EMEA functional transparency

- all members of EMEA committees and advisory boards will be obliged to list their conflicts of interest on a yearly basis. This list will be available to the public, but only on request from the Agency (amendment 110 article 56-2-1, 1a and 2), making this obligation ineffective;

- the Commission rejects the notion that the database on medicinal products, for which EMEA will be responsible, should permit comparison of drugs with similar indications (amendment 91 article 51-1-2-j);

- most of the amendments concerning EMEA transparency approved on 23 October 2002 by the European Parliament were based on European Regulation 1049/2001, related to document databases and their ready access by European citizens (especially amendments 38, 43, 51, 53, 79, 81, 87, 109 and 131). The Commission claims it accepts this principle of document access, but considers that some documents are already accessible and do not require any further obligations (e.g. European Public Assessment Reports). The Commission states that access to other documents will be guaranteed through a "separate proposal by the Commission". Other documents, according to the Commission, do not need to be grouped together in registers, as they will already be accessible through a separate database. This is the case of clinical trial registration, for example, but the Commission's proposal would mean they would be separated from the marketing authorisation data. Finally, the Commission proposes creating "hierarchical access" to documents, depending on whether the request comes from a pharmaceutical firm, a health professional, or a member of the public (the case of adverse effects, for example).

This complex system of access to public documents must be rejected, and Regulation 1049/2001 must be strictly applied.

EMEA functioning

- the Commission accepted the principle that rapporteurs in charge of marketing applications should be able to seek the opinion of patient organisations. However, while Parliament wanted to make this obligatory, the Commission proposes simply that: "the rapporteur may establish contact" (amendment 105 article 55-1-1). This point has not yet been settled through the Commission-Council compromise procedure;

the EU Parliament also recommended that presidents of EMEA scientific committees be obliged to participate in meetings of the Agency's management board. The Commission is seeking to make this participation optional (amendment 118 article 58-3);

the Commission's first draft Regulation proposed that the centralised marketing authorisation procedure (conducted by the European Medicines Evaluation Agency) should become obligatory for new all drug substances. This centralisation would avoid the use of the current mutual recognition procedure, which is often less demanding and more secretive. Many countries remain hostile to this proposal, which is still under discussion;

representatives of patients, physicians and social security systems will sit on the Agency's management board (amendments 116, 117 article 58-1 and 2). However, this point is still under discussion, one country opposing the presence of social security representatives;

the Commission rejects the notion that patient representatives should sit on the Agency's Advisory Board (amendment 119 article 59-1);

the Commission rejects the section of amendment 91 (article 51-1-2-j) concerning the independent funding of the EMEA database, considering that "it cannot be excluded that pharmaceutical firms do not contribute financially to the development of this database".

along the same lines, the Commission refused the amendment aimed at ensuring public funding of the Agency's core tasks (amendment 152 recital 17a). The Commission considers that "fees [paid by companies] should serve to pay for the services carried out for industry; the community contribution should serve to finance the tasks of a public nature required of the Agency by the legislators (…)". The Commission nonetheless recognises the need for "adequate" public funding of pharmacovigilance activities, "market surveillance" and "communication networks" (amendment 121, article 60);

the marketing authorisation Committee (the current CPMP) will comprise only one representative of each Member State (instead of two). The Forum fears that the CPMP will be made up solely of administrative representatives of national medicines agencies, and would prefer to see one administrative and one scientific representative of each country. If the Commission's concern is to avoid complicating meetings after EU enlargement, the Forum proposes that the two representatives of each member state have a single vote.

Evaluation of medicinal products

- the Commission rejected an amendment stipulating that the rationale underlying marketing authorisations should be explained for each therapeutic indication, arguing that this is already the case. The Forum would find it more reassuring if this practice became obligatory in the Regulation;

- the Commission rejected amendments calling for a minimum of 90 days for the scientific assessment of marketing applications during the standard centralised procedure, and for possible extension of this period in special cases (amendments 175 and 45 articles 6-3-1a, 1b, 1c and article 1362a, 2b). The Commission considers this to be a "detail" that can be dealt with through EMEA internal procedures. Yet the Forum feels that such a measure must be explicitly stated in the Regulation in order to guarantee the quality of scientific evaluation;

- the Commission accepts in principle the amendment referring to the principle of comparative efficacy (of a new drug relative to available treatments) (amendments 4 and 100, recital 11 and article 53a). The Commission even recalled that the Council of Health Ministers had underlined (on 29 June 2000) the importance of identifying drugs with added therapeutic value.
But, according to the Commission, "this evaluation should not be conducted in the context of the marketing authorisation for which it is agreed that the fundamental criteria should be retained". In the Commission's opinion the only important criteria for judging a new drug are its quality, safety and efficacy. It therefore proposes a simple "survey" of methods used by Member States to determine the added therapeutic value of new drugs. But these methods have been known for years, and such a survey would appear pointless.

The Medicines in Europe Forum would like to see a system that encourages firms to provide comparative information on their drugs. At the very least, it should be officially stated, when appropriate, that marketing application files do not contain such data. Whatever the state of the application, the Agency's assessment report should contain the CPMP's opinion on the added therapeutic value of the drug in question, or simply state that it cannot be determined, as a matter of basic transparency.

Pharmacovigilance

- patients will be invited to notify adverse effects to health professionals, and, possibly, to the relevant authorities (amendment 54 article 20-3). This point is still under discussion, however, as several Member States do not want to be encumbered by patient notifications;

- the Commission did not accept that all patient leaflets bear words to the effect: "newly authorised medicinal product; please report any adverse effects" for the first five years (amendment 42 article 13-3a), under the pretext that it does not want patients to notify adverse effects directly to the companies, but only to Agencies and health care professionals (see above). But this has nothing to do with the need to call patients' attention to the fact that new drugs must be closely monitored. Patient notification is already accepted practice in many countries (New Zealand, Sweden, United Kingdom);

- The EU Parliament recommended that EMEA actively collate pharmacovigilance data on new drugs during the first two years on the market; the Commission prefers to make this measure optional, under certain conditions, but for a 5-year period (amendment 64 article 24-3a);

- the Commission did not accept that the EMEA database should contain pharmacovigilance data (amendment 157 article 51-2), under the pretext that a specific pharmacovigilance database is planned. This simply confirms the Commission's ploy to maintain a complicated information maze that would hinder public access.

Compassionate use

- drugs for compassionate use will remain free of charge for the patients concerned (article 73-6). However, the relevant article must be worded more precisely: if not, responsibility for funding such treatments is likely to be passed around drug companies, member States and EMEA like a hot potato;

- the draft Regulation offers no guarantees that compassionate use programs will be effectively created for all patient groups in need. Patient representatives and health professionals must therefore be able to ask national agencies and EMEA to intervene.

Data protection

- the Commission rejected an amendment stating that some member states could be exempted from the planned 10-year data protection (some states only protect data for 6 years) (amendment 46 article 138). Several countries want this point to be dealt with at the same time as the corresponding item in the draft Directive.

Developing countries

- the Commission rejected all amendments calling for active solidarity with poor countries (only safe and effective drugs of high quality should be exported; research on diseases prevalent in the poorest countries should be stimulated; co-operation on pharmaceuticals should be developed; etc.) (amendments 7, 8, 26 and 94). The Commission considered that such proposals were beyond the scope of the Regulation. The Forum demands that these points at least be mentioned in the recitals of the final text, in order to show that Europe is truly concerned by this important issue.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003