6.7.2018   

EN

Official Journal of the European Union

C 238/128

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having regard to Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use (1) (hereinafter the ‘Paediatric Medicines Regulation’),

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having regard to the Commission report to the European Parliament and the Council entitled ‘Better Medicines for Children — From Concept to Reality — General Report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for paediatric use’ (COM(2013)0443),

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having regard to the Council conclusions of 17 June 2016 on ‘Strengthening the balance in the pharmaceutical systems in the EU and its Member States’,

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having regard to the United Nations Secretary-General’s High-Level Panel on Access to Medicines report entitled ‘Promoting innovation and access to health technologies’, published in September 2016,

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having regard to the question to the Commission on the review of the regulation on paediatric medicines (O-000135/2016 — B8-1818/2016),

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having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

A.

whereas the Paediatric Medicines Regulation has had a substantial impact on paediatric medicine development, as most pharmaceutical companies consider paediatric development to be an integral part of the overall development of a product; whereas the number of paediatric research projects has increased considerably, and whereas there is now more high-quality information available regarding paediatric use of approved medicines; whereas the relative number of paediatric clinical trials has also increased;

B.

whereas the Paediatric Medicines Regulation has helped to improve the overall situation and has led to tangible benefits in respect of a series of childhood diseases; whereas, however, not enough progress has been made in a number of fields, in particular paediatric oncology and neonatology;

C.

whereas childhood cancer remains the first cause of death by disease in children aged one year and over, and whereas 6 000 young people die of cancer each year in Europe; whereas two thirds of those who survive suffer from treatment-related side effects due to existing treatments (reported to be severe for up to 50 % of survivors), and whereas there is a need to continuously improve the quality of life of childhood cancer survivors;

D.

whereas the Paediatric Medicines Regulation has fostered increased multi-stakeholder dialogue and cooperation on paediatric medicine development;

E.

whereas fewer than 10 % of children with a non-curable life-threatening relapse have access to new, experimental drugs in clinical trials from which they could benefit;

F.

whereas significantly increased access to innovative therapies can save the lives of children and adolescents with life-threatening diseases such as cancer, and whereas these therapies therefore need to be investigated without undue delay via appropriate studies in children;

G.

whereas off-label use of medicine in children is still widespread in the EU in several therapeutic areas; whereas, although studies on the extent of off-label use in the paediatric population differ in scope and patient population, there has not been a decrease in off-label prescribing since the introduction of the Paediatric Medicines Regulation; whereas the European Medicines Agency (EMA) has already been called on to develop guidelines on the off-label/unlicensed use of medicines based on medical need, and to compile a list of off-label medicines in use despite licensed alternatives;

H.

whereas the Paediatric Medicines Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population;

I.

whereas only two innovative targeted anti-cancer drugs have been authorised for a paediatric malignancy based on an agreed paediatric investigation plan (PIP) since the Paediatric Medicines Regulation came into force;

J.

whereas under the current regulatory framework the legal requirement to pursue paediatric drug development is waived when drugs are developed for adult conditions that do not occur in children; whereas this regulatory approach is unsatisfactory in the case of specific diseases that are found only in children; whereas, furthermore, the number of annual reports on deferred measures submitted to the EMA under Article 34(4) of the Paediatric Medicines Regulation is increasing every year;

K.

whereas many childhood cancer types do not occur in adults; whereas, however, the mechanism of action of a drug that is effective in treating an adult type of cancer may be relevant to a cancer type that occurs in children;

L.

whereas for those diseases that occur only in children, such as paediatric cancers, the market provides limited incentives for the development of specific paediatric drugs;

M.

whereas the third EU Health Programme (2014-2020) includes a commitment to improving resources and expertise for patients affected by rare diseases;

N.

whereas there are major delays in starting paediatric clinical trials for oncology drugs, as developers wait for the drug to show promise in adult cancer patients first;

O.

whereas there is nothing to stop an investigator from terminating a promising paediatric trial early if a drug fails to deliver positive results in the target adult population;

P.

whereas financial rewards and incentives for developing drugs in the paediatric population, such as paediatric-use marketing authorisation (PUMA), arrive late and have a limited effect; whereas, while it is necessary to ensure that the rewards and incentives are not misused or abused by pharmaceutical companies, the existing rewards system must be assessed in order to determine how it could be improved to better stimulate research and development in the area of paediatric medicines, especially in paediatric oncology;

Q.

whereas marketing authorisation holders are required to update product information to take account of the latest scientific knowledge;

R.

whereas PIPs are approved following complex negotiations between regulatory authorities and pharmaceutical companies and too often prove unfeasible and/or are started too late because of their misuse through a focus on the rare occurrence of an adult cancer in a child, rather than on the potentially wider use of the new drug in other relevant children’s cancers; whereas not all approved PIPs are completed, given that research into an active substance is often abandoned at a later stage if initial hopes regarding the safety and efficacy of the medicinal product are not confirmed; whereas to date only 12 % of approved PIPs have been completed;

S.

whereas Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use provides for the establishment of a single application portal allowing sponsors to submit a single application for trials conducted in more than one Member State; whereas such cross-border trials are particularly important for rare diseases such as paediatric cancers, as there may not be enough patients in one country to make a trial viable;

T.

whereas a large number of modifications are made to PIPs; whereas, however, if extensive modifications to a PIP are discussed with the Paediatric Committee, where the modifications have a lesser impact, the issue is less clearly defined;

U.

whereas, in accordance with Article 39(2) of the Paediatric Medicines Regulation, the Member States must provide the Commission with detailed proof of a concrete commitment to supporting research into and the development and availability of medicinal products for paediatric use;

V.

whereas, pursuant to Article 40(1) of the Paediatric Medicines Regulation, funds for research into medicinal products for the paediatric population are to be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate;

W.

whereas, under Article 50 of the Paediatric Medicines Regulation, the Commission is required to present, by 26 January 2017, a report to Parliament and the Council on the experience acquired as a result of the application of Articles 36, 37 and 38, including an analysis of the economic impact of the rewards and incentives, together with an analysis of the estimated public health impact of this regulation, with a view to proposing any necessary amendments;

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