Healthy Skepticism Library item: 1120
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
European Union pharmaceutical legislation review
Health Action International 2003 May 10
Full text:
(i) Article 88, Directive on the Community Code relating to medicinal products for human use
The European Commission has proposed relaxing the ban on advertising prescription drugs to the public. Substantial evidence from the USA and New Zealand, the only two industrialised countries that permit such advertising, shows that industry advertising of prescription drugs directly to consumers:
drives up drug costs threatening the sustainability of national health care services,
increases the amount of misleading and unhelpful information, and
increases the inappropriate and unnecessary use of medicines.
The Commission’s proposal will also have a global impact that threatens to strain health systems and budgets in EU candidate countries in Eastern and Central Europe, and in developing countries.
People need comparative information on the pros and cons of drug and non-drug treatments and the option not to treat. This type of information does not require a change in advertising legislation. It cannot be produced by pharmaceutical companies which have a vested interest in selling a specific product.
The European Parliament voted overwhelmingly (494/42) to reject this proposal. We urge Health Council members to reject the Commission’s proposal on Article 88.
(ii) Article 12-3 & Recital 28a, Regulation concerning medicine authorisation, EMEA etc.
It is essential for patients, health care professionals and providers of independent drug information to know whether or not a new drug offers added therapeutic value. Although added therapeutic value of new medicines is not a condition of marketing authorisation, assessment reports need to provide such an analysis based on available data. Failure to do so deprives people of useful information.
We urge Health Council members to require the addition of the following sentence to Article 12-3: “European Public Assessment Report (EPAR) conclusions will mention available data comparing the new medicinal product with existing treatments. It will provide a judgement on the degree of added therapeutic value offered by the new medicinal product, or state that comparative data are insufficient or lacking to determine the degree of added therapeutic value.”
A sentence should also be added before the last sentence of recital 28a specifying that: “The EPAR must nevertheless mention available comparative data determining the place of the new medicinal product relative to existing treatments, or, if need be, the lack of comparative data.”
(iii) Articles 51-1, 51-2 & 70 of the Regulation
In order to provide and use quality information, people must be able to access documents held by the European Medicines Evaluation Agency through registers, without delay (as outlined in European Regulation 1049/2001 on document access). Examples include documents relating to current and completed clinical trials, detailed evaluation reports on new medicines granted marketing authorisation, minutes of committee meetings, pharmacovigilance data etc (respecting patient privacy). EMEA must conform to this regulation, adopted in June 2002, and must no longer simply offer a façade of transparency. Regulation 178/2002 outlines clearly the requirements for accessing documents from the European food authority. Why should documents regarding medicines be shrouded in secrecy compared to those on food?
We urge Health Council members to ensure transparency through the clarification, simplification and effective application of Articles 51 & 70.
