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Document 52012SC0268
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
/* SWD/2012/0268 final */
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors /* SWD/2012/0268 final */
TABLE OF CONTENTS 1........... Introduction.................................................................................................................... 5 2........... Procedural issues and
consultation of interested parties.................................................... 6 2.1........ Internal consultations....................................................................................................... 7 2.2........ Stakeholder consultation................................................................................................. 7 2.3........ Scrutiny by the Commission Impact Assessment Board................................................... 8 3........... Policy Context................................................................................................................ 9 3.1........ International context........................................................................................................ 9 3.2........ EU context................................................................................................................... 10 4........... Problem definition......................................................................................................... 11 4.1........ Scope of the problem................................................................................................... 11 4.2........ Scale of the problem
(methamphetamine and its precursors)........................................... 14 4.3........ Underlying drivers of the problem.................................................................................. 17 4.4........ Foreseen evolution of the problem................................................................................. 17 4.5........ Who is affected by the identified
problem?.................................................................... 18 4.6........ EU right to act.............................................................................................................. 18 5........... Objectives.................................................................................................................... 19 5.1........ General policy objectives.............................................................................................. 19 5.2........ Specific policy objectives.............................................................................................. 19 5.3........ Operational objectives.................................................................................................. 19 5.4........ Consistency with other policies
and objectives............................................................... 19 6........... Policy options............................................................................................................... 20 6.1........ Option 1: taking no new
legislative action (baseline option)............................................. 20 6.2........ Option 2: Recommending voluntary
measures to Member States.................................... 22 6.3........ Option 3: Increasing the powers
of competent authorities............................................... 22 6.4........ Option 4: Increasing the powers
of competent authorities (Option 3) and introducing pre-export notifications 23 6.5........ Option 5: Subjecting medicinal
products containing ephedrine or pseudoephedrine are subject to the same
control requirements as ephedrine and pseudoephedrine............................................................ 24 6.6........ Option 6: banning trade of
medicinal products containing ephedrine and pseudoephedrine 24 7........... Analysis of impacts....................................................................................................... 25 7.1........ Option 1: taking no new
legislative action (baseline option)............................................. 26 7.1.1..... Effectiveness................................................................................................................. 26 7.1.2..... Cost efficiency.............................................................................................................. 27 7.2........ Option 2: Recommending voluntary
measures to Member States.................................... 27 7.2.1..... Effectiveness................................................................................................................. 27 7.2.2..... Cost efficiency.............................................................................................................. 28 7.3........ Option 3: Increasing the powers
of competent authorities............................................... 28 7.3.1..... Effectiveness................................................................................................................. 28 7.3.2..... Cost efficiency.............................................................................................................. 29 7.4........ Option 4: Increasing the powers
of competent authorities and introducing pre-export notifications 29 7.4.1..... Effectiveness................................................................................................................. 29 7.4.2..... Cost efficiency.............................................................................................................. 30 7.5........ Option 5: Subjecting medicinal
products containing ephedrine or pseudoephedrine to the same control
requirements as ephedrine and pseudoephedrine............................................................ 31 7.5.1..... Effectiveness................................................................................................................. 31 7.5.2..... Cost efficiency.............................................................................................................. 31 8........... Comparing the options.................................................................................................. 33 9........... Monitoring and evaluation............................................................................................. 35 9.1........ Measuring the fulfilment of
objectives............................................................................ 35 9.2........ Monitoring the implementation of
the new legislative measures........................................ 35 9.2.1..... Collecting, analysing and
publishing statistics.................................................................. 35 9.2.2..... Monitoring difficulties in the
implementation................................................................... 36 9.2.3..... Involvement of stakeholders.......................................................................................... 36 9.2.4..... Supporting the implementation of
the new legislative measures........................................ 36 9.2.5..... Guidelines..................................................................................................................... 36 9.2.6..... Activities...................................................................................................................... 36 9.3........ Monitoring results and exchange
information with the third countries concerned.............. 36 9.4........ Overall evaluation......................................................................................................... 37 10......... ANNEX...................................................................................................................... 37 COMMISSION
STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the
European Parliament and of the Council amending Council Regulation (EC)
No 111/2005 laying down rules for the monitoring of trade between the Community
and third countries in drug precursors 1. Introduction Drug precursors are chemical substances
having a wide variety of licit uses, such as in the synthesis of plastics,
pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded
for legitimate purposes on regional and global markets, but some of them can
also be diverted from the licit distribution channels for the illicit
manufacture of narcotic drugs and psychotropic substances. In other words, "there is no production
of illicit drugs without drug precursors". Therefore, controlling drug precursors is a
key component in the fight against narcotic drugs. Taking into account the wide
legitimate uses of drug precursors, their trade cannot be prohibited. A
specific regulatory framework, both at international and at EU level, has been
put in place to monitor their legal trade and to identify suspicious
transactions, thus preventing their diversion for illicit use. An effective
cooperation between the competent authorities and the industry is key to the
implementation of this regulatory framework. These chemicals are rarely produced by
criminals that intend to use them for their illicit purposes as their
production often requires substantial infrastructure. Criminals tend to either
smuggle or divert them from the licit trade by exploiting weaknesses of
national control systems to their benefit. The weakness identified in the
control system of international trade in drug precursors concerns medicinal
products containing ephedrine or pseudoephedrine[1]
(drug precursors) exported from or transiting through the Union customs
territory which are diverted for the illicit manufacture of methamphetamines[2] in other countries of the
world. The EU is criticized internationally for not taking adequate control
measures across Member States to tackle this weakness. The EU is expected to
close the loophole in the current legislation as regards the powers conferred
to customs and police authorities who can stop and seize ephedrine and
pseudoephedrine but cannot stop and seize medicinal products containing
ephedrine or pseudoephedrine. By imposing EU control over these medicinal
products, we are aiming to make it more difficult, expensive and risky for
criminals to source the chemicals they need to manufacture drugs. This proposal
should work as a deterrent: it focuses on preventing the diversion of
precursors. It does not aim to solve health problems and reduce criminality
related to drug abuse; it concentrates on the supply reduction of the chemicals
to make drugs and not on the supply of the drugs for the consumers. The present impact assessment refers to
measures to address this specific weakness concerning the trade in drug
precursors between the Union and third countries, under Regulation (EC) No
111/2005[3],
which is under the responsibility of DG Taxation and Customs Union (DG TAXUD).
Another impact assessment, carried out in parallel, concerns intra-EU trade in
drug precursors, Regulation (EC) No 273/2004[4], under the responsibility of DG Enterprise
and Industry (DG ENTR) and focuses on strengthening controls over acetic
anhydride, the main heroin precursors, within the Union. 2. Procedural
issues and consultation of interested parties The proposal to amend Council Regulation
(EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of
trade between the Community and third countries in drug precursors was
announced in the 2011 Commission Work Programme and further scheduled in the
2012 Commission Work Programme. This initiative follows on from the Council
Conclusions on the functioning and implementation of the EU drug precursor's
legislation[5]
inviting the Commission "to set a work programme to address the identified
weaknesses in the legislation in co-operation with Member States and to propose
legislative amendments before the end of 2011 after carefully assessing their
potential impacts on Member States’ authorities and economic operators". The Council conclusions were based on the
Commission Report to the Council and the European Parliament issued in January
2010[6]. The underlying evaluation to
the Commission report had been carried out by the Commission Services, with the
assistance of a group of experts from competent national authorities, which had
been established for the evaluation purposes. In addition, the Commission had
mandated an external contractor, the consultancy RPA to gather further
information[7]. 2.1. Internal consultations The preparation of this Impact Assessment
was monitored by an Inter-service Steering Group, composed of Directorates
General TAXUD, ENTR, HOME, JUST, OLAF and SANCO and from the Legal Service and
the Secretariat-General. The Steering Group met on four occasions. Its last
meeting was convened on 14 December 2011. 2.2. Stakeholder
consultation A stakeholder consultation was held from 30
June to 13 September 2011. This was not a public consultation, given the
sensitivity and the peculiarity of the matter at stake. On the one hand, the
subject matter, drug precursors, is not widely known and would have most likely
entailed responses concerning the overall drug situation, which would have been
irrelevant for this exercise. On the other hand, the problem at stake and the
envisaged options only affect a very specific aspect of drug precursor control.
Only the most concerned stakeholders were therefore consulted. The responses of
the stakeholders were treated confidentially; they have not been published on
the Commission website to avoid providing sensitive information to traffickers.
All the contributions have been taken into consideration for the analysis in
this impact assessment. The consultation consisted of two types of
questionnaires[8],
one targeted to national authorities and one targeted to the pharmaceutical
industry, including small and medium-sized enterprises. The questionnaires were
introduced in the Interactive Policy Management (IPM) tool of the Commission.
The link to these questionnaires was sent to the specific stakeholders, namely
Member States' competent authorities (customs, police and health) and economic
operators (9 pan-European[9]
pharmaceutical associations representing the major components of the
pharmaceutical industry). Two of these pharmaceutical associations with a high
proportion of SME member companies were consulted, as it was not possible to
target only those SMEs marketing medicinal products containing ephedrine or
pseudoephedrine (the databases currently available are devised for commercial
purposes and do not allow selecting this kind of information). Small and
medium-sized enterprises were also consulted through the Enterprise Europe
Network. In response to this consultation the
Commission received 31 contributions. Of these, 22 were from national
authorities (3 of which were partial replies) and 8 from the industry (6
manufacturing companies and 2 pharmaceutical associations). From the absence of
replies from SMEs and as confirmed by the industry, SMEs are not much involved
in the trade of medicinal products containing ephedrine or pseudoephedrine, or
are working for the few multinational firms that are active in this segment. Chart 1 here below shows that the industry
is unanimous in favouring the baseline scenario as they take the stance that
this is not an EU-wide problem but rather a regional one. Subsequent
consultations with the Association of European Self Medication Industry (AESGP)
revealed that options 3 and 4 would not be opposed by industry since the
administrative burden on exporting companies would be minimal or even
inexistent. However, Member States' competent authorities are equally split
among the various options; two thirds plead for an amendment of the legislation,
though to different degrees; one third is in favour of no change in the
legislation, considering that their drug legislation provides for the
possibility for customs and police authorities to stop and seize products,
which are likely to be used for the illicit drug manufacture, including
medicinal products containing ephedrine or pseudoephedrine. Results concerning option
2 do not appear in this Chart because this option lists a series of measures
for which stakeholders were asked only to assess the degree of their
effectiveness. Chart 1. Options selection - Overview The
Commission maintained regular contacts with the competent authorities of the
Member States throughout the review process in the last year and there was an
active dialogue to identify the main problems and the possible options to
address them, notably: - through the Drug Precursors Working Group
meetings, composed of Member States' representatives and the Commission which
meets twice per year; - through the "Drug Precursors Project
Group" created under the Customs 2013 Programme, composed of operational
experts from Member States which meets twice per year; and - at a "Roundtable on medicinal
products containing ephedrine and pseudoephedrine", composed of Member
States' competent authorities for drug precursors and for medicinal products
which was held on 7 December 2009. The main results of these consultations are
summarised in Annex 2. 2.3. Scrutiny by the Commission Impact Assessment Board The Impact Assessment Board of the European
Commission assessed a draft version of the present impact assessment and issued
its opinion on 29 February 2012. The Impact Assessment Board made several
recommendations and, in the light of the latter, the final impact assessment
report: - presents the scope of the proposal more
clearly; - indicates the volume of licit trade of
medicinal products containing ephedrine and pseudoephedrine at European and at
global level; - explains how these products are diverted
for the illicit manufacture of methamphetamine; - gives an overview of the drug legislation
in the Member States and of the powers of their customs and police authorities; - considers a sixth option which consists
in a trade ban of these products; - strengthens the analysis of impacts
through better emphasizing the cost-efficiency and effectiveness criteria; and - provides an overall evaluation review
exercise, as well as specific progress indicators. 3. Policy
Context 3.1. International
context The United Nations Convention against the
Illicit Traffic in Narcotic Drugs and Psychotropic Substances contains in its
Article 12 specific reference to measures to prevent diversion of drug
precursor chemicals for use in the illicit manufacture of narcotic drugs and
psychotropic substances. Tables I and II of the 1998 Convention contains the
list of 23 drug precursors (so-called "scheduled substances") which
are controlled by the Convention because they are most frequently used in the
production of illicit drugs. The EU is a Contracting Party of Article 12
of the 1988 UN Convention, which has 185 Parties including all major chemical
producing countries. The EU has implemented its obligations through legislation
and voluntary measures applied by the public and private sectors. The United Nations’ International Narcotics
Control Board (INCB) is an independent control body which closely monitors the
implementation of the United Nations drug conventions. It publishes annual
technical reports containing diversion statistics and their analysis as well as
recommendations to the countries concerned. According to the 2009 INCB report, 70% of
all identified instances of suspicious shipments or diversions of
methamphetamine precursors currently involve ephedrine or pseudoephedrine in
tablet form.[10]
This trend was further confirmed by the results of the activities under Project
PRISM[11]
with an emphasis on pharmaceutical preparations containing ephedrine or
pseudoephedrine[12],
as outlined in the 2010 INCB report[13].
In particular, of 35 cases of seizures of ephedrine and pseudoephedrine during
Operation Crystal Flow, 40 cases during Operation Ice Block and 139 cases
during Operation Pila, 11%, 27.5% and 67% respectively were in the form of
medicinal products. Some countries have therefore strengthened measures to
control these products: e.g. Malaysia and Thailand request to receive
pre-export notifications for transactions involving these products and require
an import/export licence for all import/export of these products in the same
way as the substances they contain. Other countries, such as Mexico, several
Central American countries, and Colombia entirely prohibit imports of these
products. The United States also control medicinal products
containing ephedrine or pseudoephedrine as List I chemicals under the
Controlled Substances Act. This means that these products are submitted to the
same control regime imposed to the raw substances they contain, which are List
I chemicals. They are controlled regardless of their form – bulk substances
(raw material) or tablets. Since 2006, the Commission on Narcotic
Drugs[14]
(CND), the central drug policymaking body within the United Nations, adopted
various Resolutions inviting all Contracting Parties to strengthen controls
over this type of products (the latest at the 2011 CND meeting[15]), in particular to adopt
regulatory framework to control these products containing precursors and to
encourage the use of the pre-export notification system for these products so
as to favour the rapid identification of new patterns of diversion. CND
Resolutions shape global drug control policy and direct the work of the UN
Office of Drugs and Crime (UNODC) and of the INCB on these matters. 3.2. EU
context Since the early nineties the EU has put in
place legislation to ensure that diversion of drug precursors is prevented
through control and monitoring of their legitimate trade. The existing
legislation aims at striking a balance between necessary actions to prevent
diversion of drug precursors and allowing their legitimate trade without
creating unnecessary administrative burdens. The EU legislation on drug precursors, just
like the 1988 United Nations Convention, covers the same 23 drug precursors
which are divided in three categories according to their sensitivity: - Category 1 covers the most sensitive
substances (12 substances); - Category 2 covers less sensitive
substances and “pre-precursors”[16]
(5 substances ); - Category 3 covers bulk chemicals that can
have different types of uses in the manufacturing process, such as feedstock,
but also solvents and impurities remover (6 substances). The extent of control of operators and of
trade transactions depends on the Category concerned: the strictest control
applies to category 1 substances, while the least control is imposed on
substances of category 3. A summary table comprising the obligations is
attached in Annex 3. Furthermore, the legislation builds upon
the key principle of partnership between authorities and operators in
identifying diversion attempts; a voluntary monitoring system is in operation
for non-controlled substances, providing flexibility[17] for rapidly changing diversion
patterns. The control of drug precursors is part of
the EU Drugs Strategy[18]
and the EU Drugs Action Plan (2009-2012)[19],
which sets out the objective to reduce the diversion and trafficking in/via the
EU of drug precursors used for the illicit manufacture of drugs. The responsibility for drug precursors in
the Commission is shared between DG TAXUD and DG ENTR. DG TAXUD is in charge of
Council Regulation (EC) No 111/2005 governing the trade in drug precursors
between the EU and third countries, while DG ENTR is in charge of Regulation
(EC) 273/2004 of the European Parliament and the Council relating to the trade
in drug precursors within the EU. As mentioned under point 2 above, the
European Commission’s Report COM(2009)709 assessed the functioning of the
existing EU legislation on drug precursors and, while concluding that the
system overall functions well, it also identified some weaknesses in the
existing control system of trade in drug precursors both within the Union and
between the Union and third countries. As announced in the Introduction, two
impact assessments on the European drug precursor legislations are carried out
in parallel by DG TAXUD in respect of extra-EU trade and by DG ENTR in respect
of intra-EU trade. Even though both initiatives concern the
drug precursors' legislation, they tackle two issues which are not interlinked.
This is the reason why, despite the common background, two separate initiatives
have been put forward. The two DGs have nevertheless ensured coordination all
through the procedure of preparation and writing of the respective impact
assessments. 4. Problem
definition 4.1. Scope
of the problem Ephedrine and pseudoephedrine are chemical
substances used for the manufacture of cold or allergy medicines as they are
effective nasal decongestant. These two substances are also the key precursors
for the manufacture of methamphetamines. While the raw substances, ephedrine
and pseudoephedrine, are internationally controlled according to the 1988 UN
Convention, medicinal products containing ephedrine or pseudoephedrine are not
controlled as they are excluded from the scope of the UN Convention. Based on
the 1988 UN Convention, the EU legislation also provides for the control of
ephedrine and pseudoephedrine but it does not provide for the control of
medicinal products containing ephedrine or pseudoephedrine for human use[20]. These products are regulated
in accordance with Directive 2001/83/EC on the Community code relating to
medicinal products for human use[21]
and belong to the category of over-the-counter medicines[22] or non-prescription drugs. The focus of this impact assessment is not
on over-the-counter-medicines as a category but only and exclusively on the
medicines for human use containing ephedrine or pseudoephedrine (drug
precursors). As the ephedrine and pseudoephedrine
contained in medicinal products can be easily extracted (by using cheap
home-made equipment and through a simple chemical process), these products are
specifically targeted by drug traffickers as a source of precursors for the illicit
manufacture of methamphetamines. There is a growing international concern about
increased diversion of ephedrine and pseudoephedrine when contained in
medicinal products - this is one of the findings of the ad hoc study for the
evaluation of Community legislation on drug precursors of 2009. Diversion of precursors from licit trade
can occur at any stage of handling, as illustrated in the chart here below: Traffickers have several modus operandi to
divert chemicals. The list here below is not exhaustive but gives an overview
of the main patterns. Criminals often try to cover their true identity, for instance, by using false
names and addresses; by using front-men, front companies or corrupt companies;
by misusing bona-fide names of well-known international companies. They often use criminal means to obtain
chemicals, for instance, bribery or coercion of legal companies, blackmailing
employees; theft of chemicals; falsification of documents (e.g. use of false
licences). They often disguise and blur the
destination and the consignee of a transaction, for
instance, by offering cash-payment, by using unconventional means of money
transfer or transport; by destroying documents relating to the transaction; by
picking up the chemicals themselves. They often disguise
the nature of the substance intended to be diverted, for instance, by making use
of or asking the supplier to put wrong, falsified, modified or no labels; by
making use of or asking the supplier to use generic names for the substance
(e.g. “solvent”, "thinner"). According to the 2010 INCB Report, the EU
is still being used as a transhipment[23]
point, with Germany, the Netherlands, Spain and the United Kingdom of Great
Britain and Northern Ireland having been associated with shipments from South
and South-East Asia destined for Belize, Guatemala and Mexico[24], where large scale illicit
methamphetamine manufacture takes place. The 2009 INCB
report already stated that the
route by which tableted preparations were shipped to destinations in Central
America passed through countries of the European Union. In October 2008, French
authorities seized three consignments of pseudoephedrine preparations, the
largest of which involved 11 million tablets transiting from the Syrian Arab
Republic to Honduras. The other two shipments were destined for Guatemala, one
originating in India and the other in Vietnam[25]. The fact that medicinal products for human use containing ephedrine
or pseudoephedrine are excluded from the provisions of Regulation (EC) 111/2005
has led to a situation where these products could not be stopped or seized by
Member States' competent authorities when products were exported from or
transiting through the Union customs territory. Even though it was very likely
that they would be misused for the illicit manufacture of methamphetamine, as proven
by the results of the international operational initiatives launched under
Project PRISM[26].
Some Member States customs authorities have however been using provisions of
national anti-drugs laws or the customs code to stop or seize such goods, with
more or less success. Drug traffickers therefore use the loophole in the drug
precursor legislation to source this type of products. Without a specific legal basis in the drug
precursor legislation, several Member States consider that customs control over
medicinal products containing ephedrine or pseudoephedrine when exported or in
transit cannot be performed with a view to seizing or stopping these products. For
example, in 2008 eight airfreight consignments of medicinal products for human
use containing ephedrine were exported from the EU to Mexico and another sea
container was exported to Belize. These transactions presented a combination of
risks indicators that would have urged the competent authorities to prevent the
export of the products, had they had the legal ground to perform them. This
would have prevented these products from being diverted to the illicit
manufacture of methamphetamine in Mexico, as it was established by the
investigation carried out a posteriori. 4.2. Scale
of the problem (methamphetamine and its precursors) In Europe[27]
illicit methamphetamine production is concentrated in the Czech Republic and in
Slovakia. In recent years, methamphetamine has also appeared on the drug market
in other countries in the north of Europe (Norway, Sweden, Latvia and Finland),
where it appears to have partially replaced amphetamine, the two substances
being virtually indistinguishable to users of the drugs. In 2009 almost 7400
seizures of methamphetamine, amounting to about 600 kg of the drug were reported
in Europe. Both the number of seizures and quantities increased over 2004-2009.
In 2009 illicit methamphetamine laboratories were seized for the first time in
several European countries, including Austria, Lithuania, Netherlands, Poland,
Portugal and Belarus. This is an indication that methamphetamine markets may be
expanding in Europe. At global
level, in 2009, North America accounted for 44% of global seizures of
methamphetamine, due to the continued high level of seizures in the United
States (7.5 mt[28],
compared with 7.4 mt in 2008) as well as to a sharp increase in
methamphetamines seizures in Mexico which reached a comparable level (6.1 mt,
up from 341 kg in 2008). The Asia-Pacific region
(Cambodia, Laos, Myanmar, Thailand, Viet Nam and China) continued to be
affected by manufacture, trafficking and consumption of methamphetamine on a
large scale. In 2009, seizures in East and South-East Asia rose by more than
one third, from 11.6 mt in 2008 to 15.8 mt. There are signs that
methamphetamine is reaching the region from Africa and the Islamic Republic of
Iran. West Africa is also emerging as a new source of
methamphetamine for the illicit Asian markets, with couriers transiting Europe,
West Asia or East Africa[29]. Ephedrine and pseudoephedrine are the main
precursors for methamphetamine. From 2007 until 2010, seizures of
methamphetamine precursors contained in medicinal products by EU Member States'
competent authorities at the borders have fluctuated considerably (see Chart 2
below): while in 2007 hardly any preparations were recorded out of the overall
quantities seized (0.3 mt out of 8 mt), in 2008 and 2009 the amount of
preparations out of the total quantities seized increased sharply (respectively
1.8 mt out of 3.5 mt and 0.6 mt out of 1.4 mt). In 2010 this amount decreased
considerably (0.1 mt out of 2.9 mt) even though increased quantities of
ephedrine and pseudoephedrine (raw material) were seized compared to the
previous years. Even though this amount decreased considerably in 2010, many
Member States and the International Narcotics Control Board (INCB) are
concerned about the absence of a control mechanism for the medicinal products
containing ephedrine and pseudoephedrine. Chart 2: EU
seizures of ephedrine and pseudoephedrine in raw material and in the form of
preparations Source: DG TAXUD on the basis of the figures from the
UNODC World Drug Report 2011. Global
seizures of methamphetamine precursors have fluctuated significantly. From 2007 until 2009, the following amounts were seized: 53
mt of these precursors of which 10% were in the form of pharmaceutical
preparations; 49 mt of which 30% in the form of preparations; 53 mt of which
67% were preparations; and 89 mt of which 75% were in the form of
pharmaceutical preparations[30]. After the continued increase of seizures of pharmaceutical
preparations from 2007 to 2009, as a result of strengthened controls of
pharmaceutical preparations containing ephedrine and pseudoephedrine in several
countries, particularly in Mexico and countries in Central America, the total
amount of preparations seized worldwide has decreased in 2010. The amount of
pseudoephedrine in the form of pharmaceutical preparations accounted in 2009
for 38% and in 2010 for 25% of total pseudoephedrine seized worldwide. In
south-East Asia pharmaceutical preparations are increasingly used for the
manufacture of methamphetamine. A recent case shows that large quantities of cold medicines containing pseudoephedrine have
gone missing from hospitals in Thailand. The drugs are thought to have been sent
across the border to Myanmar and Laos where they are used in the production of
methamphetamines which are then
smuggled back into Thailand for sale. From 2008 to the present, Thai
authorities have seized more than 48 million cold pills containing pseudoephedrine.
The pills were stolen from the public health system (hospitals and drug
stores). It is believed there is still a large amount of stolen pills that have
not been recovered[31]. Oceania remains a common destination for
smuggled ephedrine and pseudoephedrine in both forms. Together, Australia and
New Zealand accounted for 1.7 tons, mostly seized in the form of pharmaceutical
preparations. Diversion of pharmaceutical preparations containing
pseudoephedrine from pharmacies remains the primary source of precursors used
in the high number of small-scale illicit methamphetamine laboratories in the
United States. It appears that even though seizures are decreasing in the
EU, they are instead increasing globally. However, the increasing or decreasing
level of seizures is only one indicator to illustrate that illicit manufacture
is taking place in a given part of the world. Another indicator could be the amount of precursors diverted in
comparison with the volume of the licit trade for a given precursor and/or of
medicinal products containing ephedrine or pseudoephedrine. For any of the
precursors under international and European control, it is possible to determine the volume of trade as each precursor has a
specific tariff code in the customs nomenclature allowing to target that
specific substance. For the purpose of this initiative, it would be useful to
determine the volume of trade of medicinal products containing ephedrine or
pseudoephedrine in order to determine the percentage which is diverted for
illicit uses. As there are no specific Harmonised System codes[32] (yet) for medicinal products containing
ephedrine and pseudoephedrine, Governments are not in a position to track their
trade systematically. The only indicator that can currently be
used to determine the licit trade of these products is the information annually
reported by the Governments on the Form D[33]. Unlike
the mandatory reporting on seizures and illicit trafficking of precursors, Form
D reporting on licit trade is voluntary, pursuant to resolution 1995/20 of the
Economic and Social Council. Therefore, the licit trade data reported on the
Form D can be partial and have to be interpreted with caution. Table: Licit trade based on the 2010
Form D data: 2010 Form D data || IMPORTS (kg) || EXPORTS (kg) || EU || Global || EU || Global Ephedrine raw material || 26299 || 99954 || 18296 || 106719 Ephedrine preparations || 3114 || 3986 || 2439 || 5704 Pseudoephedrine raw material || 39899 || 898251 || 239288 || 838708 Pseudoephedrine preparations || 753 || 44546 || 1003 || 50938 According to the 2010 Form D data reported
to the International Narcotics Control Commission, the EU imported 3114 kg of
ephedrine preparations while the global figure was close to 4000 kg. The EU
figure accounts for about 78% of the global imports of ephedrine preparations. As regards the exports of ephedrine
preparations in 2010, EU exported 2439 kg which accounts for about 43% of the
global exports reported. In 2010, EU imports and exports of
pseudoephedrine preparations amount to about 2% of the global imports and
exports reported. An
attempt could be made to determine the existing demand of ephedrine and
pseudoephedrine for the purpose of methamphetamine production by making a
back-calculation from the use of methamphetamine in specific high-prevalence
countries. However, this would be misleading as methamphetamine can also be
produced with other drug precursors such as BMK or phenyl acetic acid. 4.3. Underlying
drivers of the problem The drivers can be summarised as follows: - control measures over ephedrine and
pseudoephedrine (the substances) have been strengthened worldwide. Some
countries of the world[34]
have gone to the extent to prohibit the imports of these substances. - therefore, traffickers need to look for
alternative sources of ephedrine and pseudoephedrine to manufacture methamphetamines;
they are targeting medicinal products containing these substances which are not
subject to strict control measures; and - in view of strengthening of control
measures over medicinal products containing ephedrine and pseudoephedrine in
other regions of the world. Traffickers target those regions, such as the EU,
where there are less control measures over these products, when exported or in
transit. 4.4. Foreseen evolution of the problem It is difficult to foresee the evolution of
future diversion trends, as traffickers rapidly adapt
to pressure from regulatory and law enforcement authorities by changing their
modus operandi using alternative trafficking routes and manufacturing methods
in order to circumvent legislative controls. It is likely that strengthening controls
over export and/or transit of medicinal products containing ephedrine and
pseudoephedrine in the EU legislation will result in traffickers targeting
other parts of the world where there are no or weaker control measures on these
products and/or sourcing alternative substances which can be used to
manufacture methamphetamines. However, in case of no action at the Union's
level, it is likely that traffickers will keep on targeting the EU for
diverting these products when exported or in transit. Moreover, the EU will continue to be
pressured by the UN to take action as it is the case since 2006 when the issue first
arose. 4.5. Who
is affected by the identified problem? The identified problem may affect: - third countries, where methamphetamines
are produced, whose control measures over medicinal products containing drug
precursors are not effective if not reciprocated by exporting and transiting
countries; - manufacturers and distributors located
either inside or outside of the Union, as suppliers or traders of these
medicinal products containing ephedrine and pseudoephedrine; - customs authorities, police and health
authorities, as the enforcement authorities designated within each Member State
to implement the drug precursors legislation. 4.6. EU
right to act The European Union has exclusive competence
in the area of common commercial policy, as provided for in paragraph 1 of
Article 3 of the Treaty on the Functioning of the European Union (TFEU).
Article 207 of the TFEU defines common commercial policy and trade in drug
precursors falls within this definition. In some of its policy options this
initiative suggests regulating medicinal products containing ephedrine and
pseudo-ephedrine which are already regulated by Directive 2001/83/EC. The
preamble to Directive 2001/83/EC states that the essential aim of any rules
governing the production, distribution and use of medicinal products, must be
to safeguard public health and that this must be attained without hindering the
development of the pharmaceutical industry or trade in medicinal products
within the Community. However, the directive does recognise that special
measures may be required to control the distribution of narcotic and
psychotropic substances within the territory of Member States. In any case the
objective pursued in this initiative differs, without contradicting from those
pursued by the Directive. The control mechanisms foreseen in Directive
2001/83/EC and in Regulation (EC) 111/2005 are different as they pursue
different goals. It is important, however, that any amendments do not present
unnecessary obstacles to patients' legitimate access to authorized medicinal
products. EU Member States currently try to curtail
traffickers' attempts to divert medicinal products containing ephedrine or
pseudoephedrine through different types of national measures, such as
strengthening control measures for these products by amending the national
legislation in areas of national competence, such as for drugs or medicines.
This leads to potential distortions, resulting from differing legal
requirements for EU economic operators. Whether such measures have had an
impact on the export of medicinal products containing ephedrine or
pseudoephedrine potentially diverted to methamphetamine production in third
countries is not documented. Other national measures, such as the seizure of
medicinal products containing ephedrine or pseudoephedrine by customs in some
Member States on the basis of national anti-drugs laws or the customs code also
result in a difference of control approaches and actions at the EU external
borders. It is not always possible to qualify the offence and apply the
penalties foreseen for activities related to drug trafficking, in particular
when goods are seized under the customs code. 5. Objectives[35] 5.1. General
policy objectives In line with the EU Drug Strategy
2005-2012, the general objective of this initiative is to contribute to the
world-wide combat against the illicit manufacture of drugs. 5.2. Specific
policy objectives To fight the illicit manufacture of
methamphetamines, by controlling the supply of ephedrine/pseudoephedrine
contained in medicinal products that are traded between the Union and third
countries by preventing their diversion, while not hampering legitimate trade
in these products; To maintain the free flow of medicinal
products containing ephedrine or pseudoephedrine for legitimate purposes
between the Union and third countries; To avoid disproportionate administrative
burdens on national competent authorities (customs, police, health) and on the
industry involved in the trade of medicines containing
ephedrine/pseudoephedrine. 5.3. Operational
objectives In order to contribute to the fight against
the illicit manufacture of methamphetamines, the operational objective is to
achieve and maintain a downward trend of diversion attempts of medicinal
products containing ephedrine or pseudoephedrine from the licit trade. 5.4. Consistency
with other policies and objectives The objective of achieving an effective
prevention of diversion of drug precursors to the production of illicit drugs
is ultimately aimed at reducing the supply of illegal drugs. It is thus
consistent with the drug policy outlined in the EU Drugs Strategy 2005-2012,
providing for action to reduce the supply of precursors, and, thereby, decrease
the production of drugs. In some of its policy options this
initiative suggests regulating the external trade in medicinal products
containing ephedrine and pseudo-ephedrine which are already regulated by Directive
2001/83/EC. However, the objective pursued by the Directive is to safeguard
public health by controlling medicinal products in order to ensure their
quality, safety and efficacy. Therefore, the control mechanisms foreseen in
Directive 2001/83/EC and in Regulation (EC) 111/2005 are different as they
pursue different goals. The medicinal products legislation has
recently been amended by Directive 2011/62/EU which relates to the prevention
of the entry into the legal supply chain of falsified medicinal products. The
Directive addresses inter alia the distribution chain for medicines
within the EU, importation of active pharmaceutical ingredients, and
'introduction' of medicines, i.e. medicines brought into the customs territory
without the intention of placing them on the market. These provisions are
focused on preventing products that fall within the definition of falsified
medicinal products from entering the legal supply chain. Given that the
principal issue with drug precursors is one of legitimately produced products leaving
the legal supply chain, it is unlikely that these new provisions will make a
significant contribution to tackling the issue of controlling medicinal
products containing ephedrine or pseudoephedrine being exported or transiting
through the EU. 6. Policy
options Five policy options have been identified.
The baseline scenario is outlined as option 1 to map out how the situation
could be expected to develop if no remedial action was taken. Option 2
considers contributing to improve the situation through voluntary measures by
Member States, while options 3, 4 and 5 consider resolving it through
compulsory control measures. The last three options have been built as a
crescendo depending on the number and strength of the control measures suggested.
These policy options were presented to stakeholders for comment. A further
policy option has been considered after this consultation and has been discarded
for the reasons explained below. Therefore, no further analysis of its impact
has been carried out. 6.1. Option
1: taking no new legislative action (baseline option) In this option, no measure will be
proposed. In the current legislation drug precursors, such as ephedrine and
pseudoephedrine are subject to specific control requirements, with regard to
external trade, while medicinal products containing these precursors are not.
Therefore, under the current drug precursor legislation, Member States’
authorities cannot stop or seize these products when they enter or leave the
Union customs territory, even though it is likely that they would be misused
for the illicit manufacture of methamphetamines. This has been proven by the results
achieved during the international activities organised under Project PRISM
since 2007 which focused on trade in ephedrine and pseudoephedrine, including
medicinal products containing these two substances[36]. Member States who are particularly affected
by the diversion of these products on their market have taken some measures to
control the distribution of these products. For instance, Poland has recently
restricted purchases of over-the-counter medicines containing pseudoephedrine
to a total of 720 mg of pseudoephedrine salts in one or more medicinal products
per transaction by amending their Drug Prevention Act. This measure will not be
an impediment to purchasing medicinal products for the purpose of treating
infections of the respiratory tract. It will, however, prevent bulk purchasing
of medicinal products by some consumers for non-medical purposes. Another
example is given by the Czech Republic where pharmacies must enter all
ephedrine and pseudoephedrine sales in a central register to verify that the
product has not been sold to that particular person in the same week and
purchase of these products over the internet by mail order has been prohibited. As mentioned above, some Member States
customs seize medicinal products containing ephedrine or pseudoephedrine on the
basis of national anti-drugs laws or the customs code. This results in a
difference of control approaches and actions at the EU external borders. It is
also not always possible to qualify the offence and apply the penalties
foreseen for activities related to drug trafficking, in particular when goods
are seized under the customs code because they have been misclassified[37]. While drug precursor control is an area of
Union competence, drug is instead an area of shared competence. This implies
that each Member State develops its own drug legislation, even if they all
pursue the objectives enshrined in the five-year EU Drug Strategy. From the
overview given in Annex 6, it appears that in one third of Member States the
drug legislation allows customs authorities to stop and seize medicinal
products containing ephedrine or pseudoephedrine when
it can be proven that they might be misused for the illicit drug manufacture. The
customs authorities of two thirds of Member States are not empowered for this
by their respective drug legislation. The INCB has recently requested the World
Customs Organisation (WCO) to create in the Harmonised System (HS) a specific
tariff code for medicinal products containing respectively ephedrine,
pseudoephedrine and nor-ephedrine in order to better monitor their licit trade.
For the time being, these products fall within the category of medicinal
products containing alkaloids; therefore, they cannot be targeted for specific
purposes. Even though the decision to create these new tariff codes will be
taken in the near future, the new codes will only be applicable as from 1
January 2017. It is consolidated practice that the Harmonised System is amended
every 5 to 6 years. The latest amendment entered into force in 2012 and was the
fourth one since 1996. Meantime, the European Commission has undertaken to
create new tariff codes in the EU Combined Nomenclature to identify medicinal
products containing respectively ephedrine, pseudoephedrine and nor-ephedrine,
through the relevant Committee in accordance with the Rules of Procedure of the
Customs Code Committee[38].
Once these codes are in place, companies exporting and importing these
medicines will have to indicate them in the customs declaration. This will
allow determining the volume of trade (import and exports) of these specific
products. These codes will be available as of January 2013 through the
amendment of Commission Regulation (EU) No 1006/2011 of 27 September 2011
amending Annex 1 to Council Regulation (EEC) No 2658/87 on the Tariff and
Statistical Nomenclature and on the Common Customs Tariff. This Annex is
updated annually in order to take into account any changes that have been
agreed at international level, either at the World Customs Organisation with
regard to the nomenclature at HS level, or within the framework of the World
Trade Organisation with regard to conventional rates of duty. Currently trends and diversion patterns of
medicinal products containing ephedrine or pseudoephedrine can be determined
thanks to the regular exchange of information between the EU and third
countries in the framework of their bilateral agreements on drug precursors[39]. The stakeholders' consultation showed that
this option is favoured by those Member States who consider themselves as not
directly affected by the diversion of medicinal products containing ephedrine
or pseudoephedrine, either because they have no seizures or because they have
drug legislation in force which already allow them to stop and seize these
products. 6.2. Option
2: Recommending voluntary measures to Member States In this option, the Commission would make a
Recommendation to encourage Member States’ authorities to exchange best
practices for the control of medicinal products containing ephedrine and
pseudo-ephedrine, following the existing examples (see option 6.1). Measures to be considered under this option
are the following: - restricting
the availability of purchases of over-the-counter medicines containing
ephedrine/pseudo-ephedrine through compulsory prescription; - raising awareness of pharmacies
concerning the risk of diversion of medicinal products containing ephedrine and
pseudo-ephedrine through a national campaign; - enhancing cooperation between competent
authorities and pharmaceutical companies: these companies are well placed to
notify the authorities of any suspicious order for export of medicinal
products, thus allowing an early detection of possible misuse of the products; - increasing cooperation among EU Member
States authorities and with the European Commission, on a voluntary basis, by
exchanging data on licit exports from the EU and products that have been found
by customs as smuggled, and inspections on companies established in several
Member States; This list is not exhaustive. Other measures
could be developed in cooperation with Member States in the future, drawing
from the "Information Package on the control of precursors- for use by
competent regulatory and tax enforcement authorities only"[40]. A Commission Recommendation would thus list
a number of measures from which each Member State can "pick and
choose" as they deem it appropriate. These measures are not in themselves
a solution to the diversion of medicinal products being exported from or
transiting through the EU. However, if followed in all Member States, they may
have a deterrent effect of pushing traffickers seeking methamphetamine
precursors out of the EU borders. They could also support the non-EU countries
in their identification of suspicious transactions involving the EU customs
territory. The same Member States, who consider
themselves as not directly affected by the diversion of medicinal products
containing ephedrine or pseudoephedrine, are also in favour of this option as
they consider that it is not an EU-wide issue and should therefore be left to
their discretion whether they deem necessary to implement certain control
measures on their market. 6.3. Option
3: Increasing the powers of competent authorities In this option, powers would be granted to
EU competent authorities to stop transactions involving not only scheduled
substances but also medicinal products containing ephedrine and pseudoephedrine,
when there are reasonable grounds for suspecting that these products are
intended for the illicit drugs manufacture, whether they are exported, imported
or in transit. This can be achieved by amending article 26
§1 so that it applies also to medicinal products containing ephedrine or
pseudo-ephedrine and thereby derogating from the exclusion of medicinal
products for human use in Article 2 (a)[41]. Those Member States who consider themselves
directly concerned by the diversion of these medicinal products (either because
they have seizures or because they have no other legislation in place allowing
their authorities to stop and seize these products) favour this option. Most member
States are also in favour of the following option (option 4) as they consider
the use of pre-export notification has an added value to the overall control
system. 6.4. Option
4: Increasing the powers of competent authorities (Option 3) and introducing
pre-export notifications In this option, competent authorities would
have power not only to stop and seize medicinal products containing ephedrine
and pseudo-ephedrine (as in option 3) but would also send pre-export
notifications for these products to the country of destination via PEN online
(Pre-Export Notification). Currently, Member States’ competent
authorities have the obligation under Article 11[42] to send pre-export
notifications for all exports of category 1 substances, as well as for exports
of certain category 2 substances, to the competent authorities of the country
of destination. This system enables these authorities to verify the licit
purposes of the transaction and to refuse, in case of suspicion, to import the
consignment within a period of 15 working days. In case of no reply, it is
assumed that the consignment is licit and can be exported. Moreover, simplified
pre-export notification procedures can be applied by competent authorities when
they believe that this will not result in any risk of diversion. PEN-online, developed by the International
Narcotic Control Board in 2006, is an internet-based, automated system allowing
real-time exchange of information concerning legitimate trade in chemicals
between trading countries. This system is currently used for import
and export of scheduled substances. However, it could potentially be used to
inform the country of transit, when known, about a future transaction but this
feature of the system is currently not exploited. This option can be achieved by amending
Article 26 (as in option 3) and Article 11 of Regulation (EC) 111/2005 so that
it applies also to medicinal products containing ephedrine or pseudo-ephedrine.
Under this option, for an intended export of medicinal products, the EU
competent authorities will be filling in the pre-export notification with the
information provided by the exporting company in the customs declaration, which
is the document which must be presented to customs at import or export. The
pre-export notification will be sent through PEN-online to the authorities of
the importing country, as declared by the exporting company. Once the
authorities of the importing country have confirmed that the transaction is
licit, the exportation can take place. 6.5. Option
5: Subjecting medicinal products containing ephedrine or pseudoephedrine are
subject to the same control requirements as ephedrine and pseudoephedrine In this option, medicinal products
containing ephedrine or pseudoephedrine would be subject to the same control
requirements to which scheduled substances of category 1, such as ephedrine and
pseudoephedrine, are currently submitted. Trading in these substances entails a
series of obligations for the operators: they must notify suspicious
transactions or orders to the competent authorities; they must appoint a
responsible officer who ensures compliance with the legislation; they must
obtain a licence; they must also obtain an export or import authorisation; they
must document and label all transactions and keep records for 3 years and
report annually to the competent authorities on exports, imports and
intermediary activities[43].
The obligations on the operators imply a series of tasks to be performed by the
competent authorities, i.e. to grant an export and/or import authorisation;
they must issue a licence. The competent authorities will also have to check
the legitimacy of an order before sending a pre-export notification to the
country of destination. Medicinal products containing ephedrine and
pseudoephedrine would therefore be subject to the control mechanism and
obligations foreseen for scheduled substances of category 1 by: - amending Article 2 (a) of Regulation (EC)
111/2005 through specifying that the exclusion of medicinal products defined by
Directive 2001/83 does not apply to medicinal products containing ephedrine or
pseudoephedrine; and - amending the Annex to this Regulation by
including medicinal products containing ephedrine or pseudoephedrine in the
list of category 1 substances. The competent authorities of a few Member
States would like to see these products being controlled as the substances they
contain, even though they are aware of the administrative burden that would be
imposed. 6.6. Option
6: banning trade of medicinal products containing ephedrine and pseudoephedrine In this option, import, export and transit
of medicinal products containing ephedrine or pseudoephedrine to, from and
through the Union customs territory will no longer be possible. This would go beyond the measures in force
under the current drug precursor control system, where no substance has been
banned so far. The existing legislation allows for monitoring the licit trade
in drug precursors and preventing diversion by targeted interventions by public
authorities, such as the seizure of substances that are suspected of, or the
result of a diversion for producing illicit narcotic drugs. Additionally, to be
effective, a ban on international trade in the EU would have to be complemented
by a ban on production and commercialisation within the EU. The proportionality of a ban needs to be assessed against the consequences
on legitimate producers and users of the medicinal products concerned,
including the possibilities of substitution of the banned products. Ephedrine and above all pseudoephedrine are
nasal decongestants contained in many cough and cold medicines sold
over-the-counter in most EU Member States. In the EU, non-prescription
medicines represent 50% of pharmaceutical products in volume, cough products
representing one of the main categories. The impact of a ban on these products
on the market, i.e. for the pharmaceutical industry and subsequently the
patients, would be very significant. It would be necessary to find an
appropriate substitute chemical for the production of these widely and commonly
used medicinal products, which would require clinical tests that could last
several years. Phenylephrine has been marketed as a substitute for
pseudoephedrine in the production of cold medicines in those Central America
countries which have gone to the extent to prohibit both the substances
(ephedrine and pseudoephedrine) and the medicinal products containing them.
However, there are claims that oral phenylephrine may be
no more effective as a decongestant than a placebo[44]. Before considering a trade ban, other control measures, such as those
already foreseen in the legislation, should be explored. These measures have
been analysed under option 5. 7. Analysis
of impacts This initiative respects the fundamental
rights, freedoms and principles contained in the Charter of Fundamental
Rights of the Union. In particular Article 35 of
the Charter guarantees to everyone the right
of access to preventive health care and the right to benefit from medical
treatment. Empowering competent authorities to act over medicines, as
foreseen under options 3, 4 and 5, will not reduce the access to medicines for
the public. Medicines will continue to be available to the public under the
conditions established by national laws and practices. Therefore, consumers of
these medicines will not be affected by any of these options. No environmental impact can be
associated with this problem. The only environmental aspect of the problem
could be linked to the destruction of the medicinal products seized. However,
these products will be subject to the same procedures and rules foreseen for
the destruction of all seized goods in the Community Customs Code. It is difficult to determine whether there
would be any specific impact on SMEs or micro-enterprises, as it was not
possible to target in the consultation those marketing specifically medicinal products
containing ephedrine or pseudoephedrine (the databases currently available are
devised for commercial purposes and do not allow selecting this kind of
information). However, SMEs were consulted as part of the pharmaceutical
associations and also through the Enterprise Europe Network. From the absence
of their replies and as confirmed by the pharmaceutical associations to which
they belong, they are not much involved in the trade of medicinal products
containing ephedrine or pseudoephedrine or are working for the multinational
companies that are active in this segment. Therefore, it could be assumed that
SMEs as such would not be affected by this proposal. International impacts: Diversion of drug
precursors is a global problem which requires a global response. Therefore,
control measures over drug precursors should be harmonized, to the extent
possible, at international level so that weak controls in one country do not
jeopardize the efforts of neighboring countries where controls may be more
effective. In this respect international co-operation between the EU and third
countries has a very significant role to play in preventing relevant chemicals from ending up in
the illicit manufacture of drugs. If stronger control
measures over medicinal products containing ephedrine or pseudoephedrine were
taken at EU level, this would match efforts made by other countries in the
world, thus contributing to the international objective of strengthening
controls over these products. . For policy options 3, 4 and 5, the administrative
burden for the competent authorities has been quantified using the EU
'Standard Cost model' and on the basis of the data gathered from the
stakeholders' consultation. Annex 8 presents the data and methodology on how
the additional administrative burden of the different options was calculated.
The additional administrative burden for the industry could only be
partially assessed as no data were provided by the pharmaceutical trade
associations and companies that submitted a reply to the online consultation,
given that they were all in favour of no legislative action. Subsequent
consultation with the Association of European Self-Medication Industry (AESGP)
revealed that options 3 and 4 would not be opposed by the industry since the
administrative burden on exporting companies would be minimal or even
inexistent. They had initially feared that this proposal might have an impact
on their sales and also limit the access to these medicines. Options 1 to 5 are assessed in terms of
their effectiveness in meeting the objective to prevent the diversion of
medicinal products at stake for the illicit manufacture of methamphetamine.
Three indicators have been used to determine the effectiveness of each option,
namely the reduction of the supply of ephedrine and pseudoephedrine, the
maintenance of the free flow of trade of ephedrine/pseudoephedrine medicines
and the compliance with the international regulatory framework. Options 3, 4
and 5 are also assessed in terms of cost efficiency with the aim to avoid
disproportionate administrative burden for competent authorities and the
industry. Option 6, as previously mentioned, has been discarded and is not
further assessed. 7.1. Option
1: taking no new legislative action (baseline option) 7.1.1. Effectiveness In this option the identified weakness of
the current legislation with regard to the diversion of medicinal products
containing ephedrine and pseudoephedrine would remain, allowing traffickers to
continue targeting medicinal products to source ephedrine and pseudoephedrine
for the illicit manufacture of methamphetamines. Therefore, this option will
not contribute to fighting the illicit manufacture of methamphetamine by reducing
the supply of ephedrine and pseudoephedrine contained in medicinal
products. The free trade flow of these
products for legitimate purposes between the Union and third countries will
be maintained. The seizures made over the past few years
show fluctuation trends (as already shown in section 4.2 Scale of the
Problem). It can be assumed that these fluctuations may continue. Diversion attempts concerning medicinal
products containing ephedrine and pseudoephedrine have been experienced in the
past to very different degrees by Member States. According to last years' EU
statistics (2008 to 2010)[45],
Austria, Bulgaria, Czech Republic, Finland, Germany, Sweden and UK are the most
concerned Member States. Some of these countries have introduced control
measures tailored to their needs. The argument has been made - mainly by the
industry but also by some Member State authorities –that diversion is not a
"European-wide" issue and the solution does not need to be enforced
as a strict "European-wide" approach, which legislative amendments to
the European drug precursor legislation would enforce. However, there is no
demonstration of any impact of these national measures on external trade in
these products, and on the extent to which they may have helped to prevent the
exportation and diversion of such products to other countries. Moreover, such
national measures do not address the problem of transit of pharmaceutical
preparations containing ephedrine and pseudoephedrine through the EU territory.
National measures tend to encourage traffickers to target their sourcing
activities in Member States where no or little control measures are
implemented. In addition, in the Single Market where goods circulate freely,
the effectiveness of national control measures is limited since goods can be
supplied from another Member State where such measures do not exist. Finally,
problems related to the EU external trade in goods can only be addressed at the
EU level. At the same time, under this option, the European
Union will continue to be criticised at international level for remaining
"inactive" and for neglect of the continued calls by the INCB to step
up legislative control of its external trade[46]. 7.1.2. Cost
efficiency This option provides for no changes in the
legislation, nor does it impose any additional administrative burden on
European level on either businesses or national competent authorities. As there
is no additional administrative burden and the “business as usual costs” will
remain unchanged, the administrative costs will also remain unchanged. 7.2. Option
2: Recommending voluntary measures to Member States 7.2.1. Effectiveness In this option, the Commission would
suggest to Member States' competent authorities a set of measures which can be
effective in preventing the diversion of these medicinal products. This option
will not provide for an EU response to the identified problem. It will,
however, guide those Member States which do not have any control measures in
place, to establish some on the basis of the good practice in other Member
States which have already taken some and have proven to be effective in
reducing the supply of ephedrine and pseudoephedrine for the illicit
manufacture of methamphetamine (in one of the examples provided under option
6.2, in the Czech Republic purchase/sale of these medicinal products, after
imposing restrictions, have dropped by 80% while not restricting legitimate
access to those products). In this option, if one Member State
strengthens control over medicinal products containing ephedrine or
pseudoephedrine, other Member States where no control measures over these
products are in place will automatically be targeted by traffickers seeking to
source the substances necessary for the manufacture of methamphetamines. The
absence of a homogeneous EU response will encourage traffickers to exploit
potential differences of national control systems and will alter the
level-playing field for economic operators who will be facing different
requirements within the Union. The trade flow of these products between
the Union and third countries will not be affected.
However, these specific products may be submitted to some restrictions on the
market, depending on the measures taken. It should be noted that the measures
envisaged under this option would only address the aspect of exportation of
medicinal products from the EU territory, not the transit cases. Finally, this option will not comply
with the UN Resolutions inviting all Contracting Parties to the 1988 UN
Convention to strengthen controls over this type of products. 7.2.2. Cost
efficiency This option leaves the choice of which measure
to be applied to the discretion of Member States, depending on the scale of the
problem at national level. Whatever measure they may decide to implement, one
can assume that it will imply some administrative burden at the national level.
The additional administrative burden of any of these national measures is not
assessed in the present initiative as it is unclear which measures Member
States might take. 7.3. Option
3: Increasing the powers of competent authorities 7.3.1. Effectiveness This option will establish within the drug
precursor legislation a legal basis for Member States' competent authorities to
stop[47]
or seize a consignment of medicinal products containing ephedrine and
pseudoephedrine in case they have doubts as to the legitimacy of the consignment.
Under this option, Member States' competent
authorities will no longer need to look for other legal bases to stop or seize
these products, such as national Drug Acts. The revised legislation will apply
throughout the Union in the same way, thus providing consistency across Member
States. The creation of a tariff code at EU level
for medicinal products containing ephedrine and pseudoephedrine will contribute
to better targeting these goods for the purpose of controls. This option will increase the chances to
prevent diversion, thus reducing the supply of ephedrine and pseudoephedrine for the illicit manufacture of methamphetamines.
This could result in a reduced offer of methamphetamine on the market, and
reduce its abuse. However, the effect would tend to be
temporary as criminals will turn towards other precursors to manufacture
methamphetamine or towards the manufacture of other drugs that can be produced
with other substances which are not under international control. Medicinal
products containing ephedrine and pseudoephedrine could also transit through
other parts of the world between their place of origin and their final
destination. Drug consumers could also turn their attention to other drugs more
widely available. The trade flow of medicines containing
ephedrine or pseudoephedrine will not be hampered.
Controls will be performed on these products in the same way as they are
generally carried out on the precursors they contain, according to the general
provisions of the Community Customs Code. Moreover, it will reduce the criticism
expressed by the INCB concerning the EU lack of action in imposing control
measures over these products. By reducing the risk of diversion, the measure is
expected to be positive for the third countries to which the goods are destined
and where they may be used for the illicit manufacture of methamphetamines. 7.3.2. Cost
efficiency As this option would establish a clear
legal basis for competent authorities to act over these products, controls will
be performed both at export/import and in transit on the basis of risk analysis[48] as already used in respect of
other sensitive goods internationally traded. Since this will be part of the
normal work of customs, where risk criteria vary according to trends, the
additional administrative burden is expected to be minimal. As regards traders,
customs controls being part of the normal risk they take in trading goods
internationally, the impact is also considered minimal. 7.4. Option 4: Increasing the
powers of competent authorities and introducing pre-export notifications 7.4.1. Effectiveness This option builds on the previous one,
thus maintaining all the benefits already outlined. In addition, the use of the PEN-online
system will further minimise the risk of diversion by ensuring systematic and
consistent monitoring of trade in drug precursors globally. The effectiveness
of this system is proven by the growing number of notifications sent globally
per year: 7900 notifications in 2007 increased to 25600 in 2010[49]. Thanks to this tool, this
option will enhance the chances to prevent the diversion of medicinal
products containing ephedrine or pseudoephedrine for the illicit
manufacture of methamphetamine. The use of pre-export notifications (PEN
online) for medicinal products by Member States’ competent authorities will
be praised by the INCB which has repeatedly encouraged the Union to do so
over the last years.[50] The systematic use of PEN-online by Member
States’ authorities will also be welcomed by the international community as a
whole and in particular by those countries[51]
that have already introduced legislative measures making the use of pre-export
notifications for this kind of products compulsory. Preventing the diversion of
these products is considered a global problem which requires a global response.
The more countries use PEN online, the more effective this tool will be, as this creates an unbroken chain of monitoring of international
trade. This option will contribute to this international goal. Since its creation, PEN-online has never
been recorded as slowing down or hindering trade transactions as confirmed
by the fact that a growing number of countries in the world use it – to date
126 countries out of the 184 countries which are Parties to the 1988 UN
Convention. This system provides for adequate monitoring: in cases where
shipments are suspended, appropriate action is taken rapidly by all concerned
to verify the legitimacy of an individual transaction[52]. Therefore, if its use were to
be extended to medicinal products containing ephedrine and pseudoephedrine, it
will not be an impediment to the legitimate trade. Moreover, no changes to the
online system will be necessary as it already allows indicating whether the
chemicals are in raw form or in the form of preparations. Without the legal basis enabling competent
authorities to stop and seize suspicious consignments (amendment of Article
26), the PEN system cannot be used to reduce the supply of precursors for the
illicit drug manufacture. 7.4.2. Cost
efficiency The additional administrative burden for
competent authorities in relation to the controls they will perform, under the
amended Article 26, as explained under option 6.3, will remain minimal. The average additional administrative
burden for competent authorities for sending one pre-export notification for a
category 1 substance amounts at € 15. This amount has been calculated on the
basis of data provided by 12 Member States concerning the time spent on
processing one PEN, the number of pre-export notifications sent per year and
the hourly tariff per administration. It can be assumed that the additional
administrative burden to send a pre-export notification for medicinal products
containing ephedrine and pseudoephedrine would be the same as for any other
substance of category 1, should these products be included in this category.
The additional administrative burden will mainly depend on the volume of the
licit trade for these products in each Member State. However, it can be assumed that this
additional administrative burden will be low and that it can be borne by Member
States competent authorities given that over the last three years they have
already been sending information voluntarily over the last three years during
the international operational initiatives under Project Prism[53]. As previously mentioned, the additional
administrative burden for the industry could not be assessed as no data were
provided by the industry through the stakeholders' consultation. However, the
pre-export notification is a task for competent authorities and not for the
industry. This notification is filled in on the basis of the information
already provided by the operators in the customs declaration they are obliged
to submit prior to export. Once the authorities of the importing country have
confirmed that the transaction is licit or for a maximum of 15 working days[54], the exportation can take
place. The
potential costs for the involved operators due to the delayed export are the
same as any other potential costs they would incur should customs interrupt the
transaction to perform controls such as those generally carried out on other
goods submitted to other restrictive measure applicable to external trade. 7.5. Option
5: Subjecting medicinal products containing ephedrine or pseudoephedrine to the
same control requirements as ephedrine and pseudoephedrine 7.5.1. Effectiveness This option will strengthen considerably
controls over medicinal products containing ephedrine or pseudoephedrine, which
are currently not controlled for the purpose of preventing their diversion, as
they will be submitted to the same control regime imposed by the drug precursor
legislation to the raw substances they contain. These substances are listed in
Category 1, which covers the most sensitive substances ("key precursors"),
as outlined in the Introduction to this initiative. This option will increase the chances to
prevent diversion, thus reducing the supply of ephedrine and pseudoephedrine for the illicit manufacture of methamphetamines. However, it has been argued by the industry
and by some Member State's authorities that the requirements that would be
applicable to these medicinal products in this option would be disproportionate
to the objective pursued by the present initiative, considering that their diversion
is not an EU-wide problem. Moreover, the trade flow of these
products between the Union and third countries might be hampered by the
increased requirements with which operators will be obliged to comply in order
to export or import these products. This option will comply with the CND
Resolution inviting amongst others the Union "to apply similar
control measures for pharmaceutical preparations containing ephedrine and
pseudoephedrine as those for bulk (raw) precursor chemicals"[55]. Furthermore, this option, if retained,
would imply the amendment of the same article in the Regulation governing
intra-EU trade in drug precursors. 7.5.2. Cost
efficiency As medicinal products would be submitted to
the same control regime as category 1 substances, the current and the
additional administrative burden per requirement have been calculated on this
basis. There are four main administrative
requirements: license, import authorisation, export authorisation and
pre-export notifications. The additional administrative burden stemming from
the requirement of PEN-online has been calculated under option 4. Licence (data
available from 9 Member States' authorities). As the amount of licences issued
per year varies significantly among Member States, the administrative burden for
competent authorities to issue a licence for category 1 substances also varies
considerably. The current average administrative burden per competent authority
is € 861 per year. It can be assumed that the additional
administrative burden to issue a licence for medicinal products containing
ephedrine and pseudoephedrine would be the same as for any other substance of
category 1, should these products be included in this list. Given that
currently the average time spent to issue a licence is 88 min and that the
current average tariff of human labour per min is € 0,55, the current
administrative burden to issue a licence is € 49. This figure should serve as a
basis to assess the additional administrative burden for issuing licences,
generated by the inclusion of medicinal products in the category 1 list, which
ultimately depends on the volume of trade in those products in each Member
State. Import authorisation (data available for 10 Member States' authorities). As the amount
of import authorisations per year varies significantly among Member States, the
current administrative burden for competent authorities to grant an import
authorisation for category 1 substances also varies considerably. The current
average administrative burden per competent authority is therefore € 1236 per
year. As
previously, it can be assumed that the additional administrative burden to
grant an import authorisation for medicinal products containing ephedrine and
pseudoephedrine would be the same as for any other substance of category 1,
should these products be subjected to the same requirements. Given that the
current average time spent to grant an import authorisation is 48 min and that
the current average tariff of human labour per min is € 0.59, the current
administrative burden to grant an import authorisation is € 28. This figure
should serve as a basis to assess the additional administrative burden for
granting import authorisations, which depends on the volume of trade in those
products in each Member State. Export authorisation (data available for 9 Member States' authorities). Likewise, the
amount of export authorisations per year varies significantly among different
Member States. Therefore, the current administrative burden for each Member
State also differs. The average administrative burden per competent authority
is € 995 per year. Once more, it can be assumed that the
additional administrative burden to grant an export authorisation for medicinal
products containing ephedrine and pseudoephedrine would be the same as for any
other substance of category 1, should these products be included in this
category. Given that the current average time to grant an export authorisation
is 51 min and that the current average tariff per min is € 0.56, the current
administrative burden to grant an export authorisation is € 29. This figure
should serve as a basis to assess the additional administrative burden for
granting export authorisations, which depends on the volume of trade in those
products in each Member State. Due
to the fact that a realistic forecast cannot be made without knowing the volume
of trade in medicinal products containing ephedrine or pseudoephedrine per
Member State, for the sake of this impact assessment, the calculations have
been made on the assumption that 100 exports or imports of medicinal products
are performed per year per competent authority (see Table 1. Comparing the
options). As far as the industry is concerned,
despite the fact that no data were received, costs for obtaining the licence
could be assumed on the basis of the licence fee charged by the competent
authorities. The price range for the licence varies considerably among Member
States, ranging from € 0 to as much as € 4348 (average: € 399). Moreover, the
administrative burden per company to obtain a licence has been calculated in
the framework of the impact assessment carried out by DG ENTR[56], this figure (€ 77) has been
taken over in this impact assessment. As costs for obtaining an import
authorisation or an export authorisation were not notified in response to the
consultation addressed to the industry, it may be assumed that these costs are
marginal. As regards pre-export notification, as previously explained, this is
primarily a task for competent authorities and not for the industry and,
therefore, any burden for the industry will not be significant. For the purpose of comparing the options,
the additional administrative burden for competent authorities was calculated
on the administrative costs generated by import and export operations. An
export operation implies administrative costs for a licence (€ 49), for an
export authorisation (€ 29) and for a pre-export notification (€ 15), while an
import operation implies administrative costs for a licence (€ 49) and an
import authorisation (€ 28). Thus the additional administrative burden of one
competent authority dealing with one export operation is € 93. For an
assumption of 100 operations, the administrative cost would be € 9300. For an
import operation, the costs would be respectively € 77 and € 7700 as shown in
Table 1. Comparing the options. 8. Comparing
the options The following table has therefore been
drawn in order to show the effectiveness and cost efficiency of each option,
thus contributing to the analysis of the most preferred one. Table 1: Comparing the options Options || || Effectiveness || || Cost Efficiency || || Overall Assessment || Reducing supply of EPH/PSE contained in medicines by preventing their diversion || Maintaining the free flow of EPH/PSE medicines between the EU and third countries || Compliance with UN Resolutions || Additional administrative burden Per authority || Per industry 1 || - || + || - || € 0 || € 0 || - 2 || -/+ || + || - || € 0/+ || € 0/+ || - 3 || + || + || -/+ || € 0/+ || € 0/+ || ++ 4 || ++ || + || + || € 1500* || NA || +++ 5 || +++ || +/- || + || Exports = €9300** Imports = €7700 || Licence = €77*** || ++ * As the volume of trade is not known, these calculations
have been made on the assumption on 100 pre-export notifications per year. ** As the volume of trade is not known, these calculations
have been made on the assumption on 100 export operations (licence, export
authorisation, pre-export notification), 100 import operations (licence and
import authorisation) and 100 licences per year. *** The same company only needs one licence independently from
the number of transactions (import/export) they perform. Even though the baseline scenario does not
imply any additional administrative burden, retaining this option should be
excluded if the Commission is to respond adequately to the Council's request to
address the weaknesses identified in the control system of the drug precursor
legislation and to concerns expressed by the international community. Non-legislative measures, unless adopted
across all Member States, would only partially address the identified problem.
A compulsory application of these measures cannot be enforced by the instrument
foreseen under option 2. Moreover, it will not enable competent authorities to
stop or seize, be it at export or in transit, medicinal products containing
ephedrine or pseudoephedrine due to the lack of a clear legal basis on these
specific goods. The measures contemplated under this option would only to a
certain extent prevent the diversion of the medicinal products containing
ephedrine and pseudoephedrine. Options 3, 4 and 5 would all provide a
clear legal basis for competent authorities to stop and/or seize medicinal
products containing ephedrine or pseudoephedrine at export from or in transit
through the Union customs territory, when there are reasonable grounds for
suspecting that these products are intended for the illicit drugs manufacture.
They would all reduce the criticism expressed by the INCB concerning the EU
lack of action in imposing control measures over these products. They would all
increase the chances to prevent the diversion of these products, thus reducing
the supply of ephedrine and pseudoephedrine for the illicit manufacture of
methamphetamines, though to different degrees. When comparing these three options
providing for legislative amendments, option 3 would generate only minor
administrative burden; the same can be expected for option 4, while option 5
would impose the highest administrative burden for both competent authorities
and economic operators. Even though option 5 could be considered the most
effective insofar as it applies the strictest controls, it would impose too
many control requirements that would seem disproportionate to the objective
pursued by the present initiative. The added value provided by option 4 if
compared to option 3 is that, under this option, the synergy of the two
combined measures increases the effectiveness of each individual measure, with
a limited additional burden given that the pre-export notification system is up
and running and that the number of pre-export notifications that could be
seemingly sent per year by Member States' competent authorities is relatively
small. Moreover, as pre-export notifications are already compulsory for
scheduled substances of category 1, it would seem logical to make them
compulsory also for the products containing them, such as medicinal products
containing ephedrine or pseudoephedrine. Option 4 would thus seem the most preferred
one: it would provide for a legal basis, would impose only one extra control
requirement and it would generate hardly any additional administrative burden. 9. Monitoring
and evaluation 9.1. Measuring
the fulfilment of objectives The Commission will continue to collect
from Member States statistics of seizures and stopped shipment of medicinal
products containing ephedrine or pseudoephedrine. These statistics will show
whether under the new legislative measures a downward trend of seizures of
diverted medicinal products and of stopped shipments (indicating diversion
attempts) can be observed. A downward trend can also potentially imply that
traffickers are avoiding the EU customs territory, as a consequence of
strengthened measures on that territory. Comparing the amount of medicinal
products seized or stopped to the overall quantity of medicinal products
containing ephedrine or pseudoephedrine traded between the EU and third
countries will be a first indicator of the percentage of diversion of these
products. This will be possible as from 2013 at EU level when the relevant
tariff codes will be created in the Combined Nomenclature and as from 2017 at
global level when the same codes will be created in the Harmonised System.
Moreover, the Commission, in cooperation with Member States, will collect
annually the number of pre-export notifications sent by competent authorities
for these products, including details about the quantities and the countries
where the products were destined. These progress indicators are outlined in
Annex 5. 9.2. Monitoring
the implementation of the new legislative measures Should Regulation (EC) No. 111/2005 be amended,
the Commission will ensure that the system put in place is monitored in order
to assess its correct functioning. This will be achieved through the following
mechanisms. 9.2.1. Collecting,
analysing and publishing statistics As in previous years, the Commission will
analyse the data provided by EU Member States which forward results relating to
the licit and illicit trade of drug precursors to the Commission on a quarterly
basis and will report yearly on statistics of customs seizures of precursors used
in the illicit manufacture of drugs. These data also include medicinal products
containing ephedrine or pseudoephedrine, thus allowing assessing if a downward
trend of diversions of these products is achieved in the short term and
maintained in the long term. In order to evaluate to what extent the new
legislative measures contribute to the operational objective of reducing the
number of attempts to divert medicinal products containing ephedrine or
pseudoephedrine, the Commission will request Member States' competent
authorities via the Drug Precursors Working Group to collect data concerning
the number of notifications of suspicious transactions, as well as the number
of pre-export notifications sent for transactions involving medicinal products
containing ephedrine or pseudoephedrine The system will be improved with the
implementation of an electronic system, which is currently being developed by
the Commission that shall facilitate the collection and analysis of statistics.
This system is scheduled to become operational in the beginning of 2013. The European Commission has undertaken to
create new tariff codes for medicinal products containing ephedrine and
pseudoephedrine in the Combined Nomenclature, through the Customs Code
Committee, Tariff and Statistical Nomenclature section, in accordance with the
relevant Rules of Procedure, which will allow determining the volume of trade
(import and exports) of these specific products. 9.2.2. Monitoring
difficulties in the implementation The Drug Precursors Working Committee,
composed of the Member States and the Commission, will continue to analyse any
issue related to the implementation of the Regulation, including the new
measures it will provide for. 9.2.3. Involvement
of stakeholders The Commission will ensure that all
stakeholders are given the opportunity to express their views and concerns with
regards to the application of the Regulation, including the new measures it may
provide for, through the appropriate channels. In particular, the stakeholders (pharmaceutical
industry) will be invited to participate in a meeting of the Drug Precursors
Working Group/Committee together with the Commission and representatives of
Member States. 9.2.4. Supporting
the implementation of the new legislative measures The Commission will develop, together with
Member States experts and interested stakeholders, a number of accompanying
activities to facilitate the implementation of the new measures. 9.2.5. Guidelines The Commission will update existing
guidelines for the implementation of the Regulation by competent authorities
and economic operators. 9.2.6. Activities The Commission will organise
awareness-raising activities involving both competent authorities and economic
operators as described under section 6.2 outlining the non-legislative option. 9.3. Monitoring
results and exchange information with the third countries concerned To maximise the impact of the measures
proposed, it would be useful to continue the exchange of information and trends
with the governments of third countries, in particular those concerned by the
production and consumption of methamphetamines. For example, the Commission is
in the process of re-launching the cooperation with Latin American countries
under the existing bilateral agreements on the control of drug precursors. This
cooperation will offer the opportunity to evaluate the effectiveness of the
measures taken at EU level and assess whether the EU continues to be a transit
platform for medicinal products containing ephedrine and pseudoephedrine
destined to Latin America. Continued dialogue with the US and China will also
be pursued on this matter. 9.4. Overall
evaluation The Commission could undertake an
evaluation of its new provisions five years after their adoption, examining the
results achieved against the objectives set and assessing any implications of
future options. It could then submit a report on the evaluation. 10. ANNEX Annex 1: Stakeholders'
questionnaires Annex 2: Summary of stakeholder
consultation Annex 3: Guidelines for operators
(page 8) Annex 4: Ephedrine/Pseudoephedrine
Laws in Central America Annex 5: Objectives Annex 6: Drug legislation in the
Member States Annex 7: Articles 2(a), 11 and
26 of Council Regulation (EC) No 111/2005 Annex 8: Methodology for
calculating the additional administrative burden of the options [1] The term 'medicinal products containing ephedrine or
pseudoephedrine' will be used throughout the text, as this is the term used in
the EU legislation. However, other terms are used to refer to these products,
in particular in case of quotations from international sources, such as:
'pharmaceutical preparations' containing ephedrine or pseudoephedrine or
'medicines' containing ephedrine or pseudoephedrine. [2] Methamphetamine is a synthetic drug which belongs to
the amphetamines-group. [3] Council Regulation (EC) No 111/2005 of 22.12.2004
laying down the rules for the monitoring of trade between the EU and third
countries, OJ L 22 of 26.1.2005, p. 1. [4] Regulation (EC) 273/2004 of the European Parliament
and the Council on drug precursors, OJ L 22 of 26.1.2005, p.1. [5] 3016th Competitiveness Council meeting
Brussels, 25 May 2010 - . [6] Report from the Commission
to the Council and the European Parliament pursuant to Article 16 of Regulation
(EC) No 273/2004 of the European Parliament and of the Council of 11
February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the
implementation and functioning of the Community legislation on monitoring and
control of trade in drug precursors, COM(2009)709 final [7] Ad hoc Study to be used in the evaluation of the
Community legislation on drug precursors, Final Report, prepared for the
European Commission, RPA, February 2009. Available in pdf format on demand. [8] Stakeholders questionnaires are reproduced in Annex
1. [9] EU Member States and other European countries such as
Norway, Switzerland, Croatia. [10] INCB
2009 Annual Report on Precursors: p.xii
http://www.incb.org/pdf/precursors-report/2009/English/Precursors_Report_09_english.pdf [11] Project PRISM (Precursors Required In
Synthetic drugs Manufacturing) is a United Nations/INCB-led
project to address diversion and trafficking of amphetamine-type stimulants
(AES) precursors. [12] This is the term internationally used to refer to
medicinal products or medicines containing these two drug precursors. [13] INCB
2010 Annual Report on Precursors: p. 6
http://www.incb.org/pdf/precursors-report/2010/en/PrecursorsReport2010_E_V10579291.pdf [14] Established in 1946, the Commission on Narcotic Drugs reviews
and analyses the global drug control situation, considering the interrelated
issues of prevention of drug abuse, rehabilitation of drug users and supply and
trafficking in illicit drugs. It takes action through resolutions and decisions. [15] Resolution E/CN.7/2011/L.5/Rev.1 on "Strengthening
international cooperation and regulatory and institutional frameworks for the
control of precursor chemicals used in the illicit manufacture of synthetic
drugs": http://www.unodc.org/documents/commissions/CND-Res-2011to2019/CND54_8e1.pdf [16] Substances which are used to produce another precursor. [17] Non-scheduled substances can be added or withdrawn form
the voluntary monitoring list upon request of one Member State and by decision
of the Drug Precursors Working Group. [18] EU Drugs Strategy 2005-2012, endorsed by the European
Council of November 2004 (15074/04 CORDROGUE 77 SAN 187 ENFOPOL 187 RELEX 564). [19] EU Drug Action Plan for 2009-2012 (2008/C 326/09). [20] Medicinal products containing ephedrine or
pseudoephedrine for veterinary use are instead not excluded in the EU drug
precursor legislation. [21] OJ L 311 of 28.11.2001, as amended. [22] Over-the-counter or OCT drugs are medicines that may be sold directly to a consumer without a
prescription from a healthcare professional, as compared to prescription drugs,
which may be sold only to consumers possessing a valid prescription. [23] The terms 'transhipment' and 'transit' are used
interchangeably in the INCB Reports, as the act of shipping goods to an
intermediate destination prior to reaching their ultimate end-use. [24] INCB
2010 Annual Report on Precursors: Point 41, p. 7 http://www.incb.org/pdf/precursors-report/2010/en/PrecursorsReport2010_E_V10579291.pdf [25] INCB 2009 Annual Report on Precursors: Point 55, p. 9 http://www.incb.org/pdf/precursors-report/2009/English/Precursors_Report_09_english.pdf
[26] See section 3.1 paragraph 4. [27] EMCDDA 2011 Annual report on the
state of the drugs problem in Europe (data of 2009), pages 14-15. [28] Mt = metric tons. 1 mt = 1000 kg [29] UNODC World Drug Report 2011, pages 156, 160 and 166. [30] Source: intelligence data from INCB. [31] Source: The Bangkok Post newspaper, published on 26
March 2012. [32] Further details under section 6.1. [33] Form D is a specific form used by the INCB to request
Governments to provide annual information on substances frequently used in the
illicit manufacture of narcotic drugs and psychotropic substances, from their
licit trade to their seizures, and methods of diversion. [34] Mexico, Colombia and several Central American countries. See Annex 4 for further details. [35] See table in Annex 5. [36] See section 3.1 paragraph 4. [37] The tariff classification indicated in the customs
declaration does not correspond to the product. [38] Customs Code Committee – Tariff and Statistical
Nomenclature section (Agricultural/Chemical sector). [39] The EU currently has concluded ten agreements on drug
precursors, namely with Turkey, the United States, Mexico, Chile, Bolivia,
Colombia, Ecuador, Peru, Venezuela and China. [40] E/INCB/2011/WP.5 – this document is confidential. [41] This Article includes the definitions of the main terms
used in the Regulation. The entire Article 2 is reproduced in Annex 7. [42] The entire Article 11 is reproduced in 7. [43] More details on how the control system works can be
found in the "Guidelines for operators" (page 8) - Annex 3. [44] F. Horak,
P. Zieglmayer,; R. Zieglmayer, P. Lemell, R. Yao, H. Staudinger, M. Danzig,
(2009). "A placebo-controlled study of the nasal decongestant effect of
phenylephrine and pseudoephedrine in the Vienna Challenge Chamber". Annals
of Allergy, Asthma & Immunology. [45] EU Annual reports: http://ec.europa.eu/taxation_customs/customs/customs_controls/drugs_precursors/seizures/index_en.htm [46] INCB Annual Reports: 2008, 2009 and 2010. [47] Stopping a consignment means that the delivery doesn't
take place, the transaction (import/export) is not carried out. [48] Risk analysis in the context of Customs control is a
working method that aims to maximise the use of Customs resources while
minimising the risk. It aims to concentrate controls on goods of highest risk
while at the same time leaving the majority of trade to flow relatively freely
through Customs. [49] Source: extract from the PEN-online system by INCB. [50] INCB Annual Reports on Precursors: http://www.incb.org/incb/precursors_reports.html [51] Thailand, Malaysia and the United Arab Emirates [52] E/INCB/2011/WP.5 this document is confidential. [53] For the period of reference 2009-2011, nine Member
States sent an average per year of 40 pre-export notifications for medicinal
products containing ephedrine or pseudoephedrine [54] As established by Article 11 of Regulation No 11/2005.
Further details under section 6.4 [55] Resolution E/CN.7/2011/L.5/Rev.1 on "Strengthening
international cooperation and regulatory and institutional frameworks for the
control of precursor chemicals used in the illicit manufacture of synthetic
drugs". http://www.unodc.org/documents/commissions/CND-Res-2011to2019/CND54_8e1.pdf [56] Administrative costs and administrative burdens imposed
by amendments of EU drug precursor legislation, Final Report, EIM, October
2011, page 24.