WRITTEN QUESTION P-2143/01

by Minerva Malliori (PSE) to the Commission

(10 July 2001)

Subject: Delays in EMEA approval of drugs

There has been a growing number of reports in the European press recently concerning the time-consuming procedures used by the European Agency for the Evaluation of Medicinal Products (EMEA) to approve new drugs. Access to new drugs is a serious matter given its direct bearing on the protection of public health in the EU.

What is the procedure for approving and placing a new drug on the market in the EU?

How much time is estimated and how much is actually required to complete the approval process?

Is the Commission examining the possibility of speeding up the procedure for approving new drugs already in circulation outside the Union which many of the population could take for common seasonal illnesses?

Answer given by Mr Liikanen on behalf of the Commission

(26 September 2001)

Regarding the first question, there are two procedures in the current Community system for obtaining a marketing authorisation in the Community:

- The mutual recognition procedure for national authorisations is applicable whenever an application for marketing authorisation for a medicinal product concerns two or more Member States. Under this procedure, the scientific evaluation is carried out by one Member State, called the Reference Member State in 210 days. The other Member State - where the same application has been lodged - then has 90 days to recognise the authorisation granted by the Reference Member State.

- The centralised procedure is currently mandatory for all medicinal products resulting from biotechnology (Part A of the Annex to Council Regulation (EEC) No 2309/93)(1), and optional for certain innovative products (Part B of the same Annex). The procedure leads to a single marketing authorisation which is valid for all Member States following scientific evaluation by the European Agency for the Evaluation of Medicinal Products(2) (EMEA).

Concerning more particularly the centralised procedure, companies have to send applications directly to the EMEA. The evaluation of the file is completed and an opinion as to whether to grant or not an authorisation is issued within 210 days of the receipt of a valid application. The Agency then has 30 days to forward its opinion to the Commission and the Commission has 30 days to prepare a draft decision, i.e. to turn the Agency opinion into a binding decision for all Member States. The draft decision is submitted to the Standing Committee on Medicinal Products for Human Use, where Member States have fifteen days to return their linguistic comments and thirty days for scientific and technical ones. When the opinion is favourable, the draft decision is forwarded to the Commission for adoption. It is then notified to the Member states and the marketing authorisation holder and is also published in the Official Journal of the European Community. Marketing authorisations granted via this procedure are valid for five years. Applications for extension must be made to the EMEA three months before this five-year period expires.

Five years after its creation this procedure is already very popular since, apart from the medicinal products for which it is mandatory, it has been largely used for medicinal products for which it is optional(3). According to a study carried out on behalf of the Commission(4), government ministries, professional organisations and patient organisations generally believe that availability of new medicines has increased since the creation of the EMEA. They also confirm that this authorisation procedure is not overly time-consuming, given that many checks have to be carried out in terms of qualify, efficacy and safety control.

The problem of drug accessibility lies very often, at a later stage, with the length of time. Some Member States need to agree on prices and reimbursement rates, after the marketing authorisation has been granted, despite the fact that Directive 89/105/EEC(5) provides for strict deadlines for pricing and reimbursement approval. However, the Commission is undertaking legal proceedings pursuant to Article 226 (ex Article 169) of the EC Treaty in case Member States do not respect the provisions of this Directive.

Despite the success of the current system, the Commission is of the view that the authorisation procedures can be improved to better keep up with scientific progress. Proposals on reviewing the existing legislation were recently launched focusing on increasing the availability of new and innovative medicinal products. It is proposed that procedures are being accelerated, simplified and modernised - and thus are becoming less bureaucratic. The centralised procedure is accessible to more types of new medicines. The text includes many progressive provisions like the creation of a fast-track registration procedure, the possibility of granting conditional authorisations, subject to additional clinical studies, availability of medicinal products in advance of authorisation on a compassionate use as well as data protection incentives.

Regarding new drugs already in circulation outside the Community, the fact that they are already authorised in another third country does not imply that the EMEA or the reference Member State in the context of the decentralised procedure are obliged to proceed to their approval. The evaluation of new drugs has to be considered on a case by case basis and will only be essentially accelerated if those fall within the categories for which the fast-track, conditional or compassionate use authorisations have been proposed.

(1) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ L 214, 24.8.1993).

(2) Instituted by Regulation (EEC) No 2309/93.

(3) From 1995 to May 2001, 171 authorisations have been granted under this procedure for medicinal products for human use and 26 for medicinal products for veterinary use.

(4) Evaluation of the operation of Community procedures for the authorisation of medicinal products, Evaluation carried out on behalf of the European Commission, Cameron McKenna - Andersen Consulting, available on http://pharmacos.eudra.org.

(5) Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (called the transparency directive) (OJ L 40, 11.2.1989).