Brussels, 13/05/2002 (Agence Europe) - Françoise Grossetête (EPP-ED, France) and Rosemarie Müller (PES, Germany) finalised their draft reports with a view to the first reading of the European Parliament on the proposals of the European Commission concerning revision of pharmaceutical legislation. Without bringing into question the essential elements of the revision proposed by the Commission, they plan to place emphasis on the interest of patients and on the essential quality and security controls of medicines. These reports have still to be examined by the parliamentary committee on the environment, health and consumer protection before being submitted to the Parliament's plenary session.
The two draft reports by Ms Grossetête concern the amendments of two 2001 directives establishing Community codes relating to medicinal products for human and veterinary use. Regarding medicines for human use, Ms Grossetête proposes Member States should be able to temporarily authorise the distribution of a non-authorised medicinal product in order to respond to the dispersion of a pathogenic agent intended to cause damage. Other than very specific cases aimed at responding to an eventual bioterrorist attack, the rapporteur mainly hopes to strengthen certain provisions of the text in order to guarantee the protection of consumers and the good use of medicines. Ms Grossetête thus recommends the introduction of a benefit/risk assessment linked to the release of the product into the environment, and hopes to make information compulsory on the precautionary and safety measures to be taken when storing the medicinal product, administering it to patients and eliminating waste. She requests that the following indication should be made on the packaging of medicinal products: "Unused or out-of-date medicines must be returned to your chemist. Do not throw them away with other rubbish". Any request for full market approval (AMM) should be accompanied by a detailed description of the pharmacovigilance system that the applicant is to set in place. Ms Grossetête proposes that the time the holder of an authorisation has for marking products should be extended to three years (instead of two as proposed by the Commission). She also takes a stance in support of a stricter limit (fifteen instead of thirty days) to the time that separates the adoption of the final opinion of the EMEA (European Agency for the Evaluation of Medicinal Products) and its transmission to the Commission, the Member States and to the party making the request. Regarding direct information to patients, Ms Grossetête is not opposed to the pilot projects proposed by the Commission for three diseases (cancer, asthma and AIDS) but it hopes to introduce a more stringent procedure for EMEA authorisation and control. In addition, each document diffused by the industry should bear an identification number and the indication: "This information must not replace consultation with your medical care dispenser". The EMEA budget should be reviewed to foresee adequate financing of this activity.
In her report on veterinary medicines, Ms Grossetête takes on board several provisions that she proposes for medicines for human use, mainly concerning assessment of the risks for the environment and the strengthening of pharmacovigilance. She proposes to extend the possibilities for treating animals that do not enter the food chain, with the provision, for example, that veterinarians may use products authorised in another Member State. She also recommends extending the time for extending initial authorisation to other species (five years instead of three in the Commission's proposal) and the protection period (eleven years instead of ten) if the holder of the initial AMM obtains, during the first eight years, additional authorisation for one or several new therapeutic indications that are believed to provide major clinical benefits compared to existing treatment.
The report by Ms Müller covers review of the EMEA authorisation and operational system. She calls for procedures to be foreseen for plant-based medicines. She proposes the creation within the agency of two specific committees for plant-based medicines and paediatric medicines. Ms Müller also hopes the obligation of clinical testing will be introduced in order to determine adequate directions for use for paediatric use. EUROPE recalls that the European Commission envisages proposing an incentive system comparable to that already set in place in the United States for making laboratories carry out clinical trials for all new products. At the same time, she considers that clinical trials concerning medicines essentially intended for western countries should be banned in developing countries. Ms Müller proposes introducing the possibility for the Commission to initiate, in the context of centralised authorisation procedures, a process for fixing prices by bringing together the company making the product and the Member State representatives, on a voluntary basis.
This mechanism would allow access to the medicine in all Member States as soon as it is authorised by the EMEA instead of having to wait for the end of the price negotiation with each national administration.
Mrs Muller also feels that each request for authorisation should be accompanied by a justification based on a product efficiency analysis in comparison with existing treatments. She would like to set a maximum time of one month between the date of the final opinion from the EMEA and the Commission's adoption of the decision authorising the medicine. Mrs Muller insists on the independence of the EMEA for whom a part of its financing should continue to be provided for by a financial donation from the Community budget. Members of the agency's administrative council and experts participating in the various committees should all make a statement of their financial interests, in order for it to be possible to verify that they do not have any interests in the pharmaceutical sector. Mrs Muller also proposes to modify the formation of the administrative council, which includes fifteen members designated by the Council and the Parliament, from a list presented by the Commission. Several other amendments aim to increase transparency. Thus, any decision by a company to withdraw its request for authorisation by a centralised procedure should be made public. Concerning the enhancement of pharmacovigilance, Mrs Muller proposed to intensify the direct participation of patients, who would be invited to inform the laboratories, the competent authority or the EMEA of any observation concerning a possible side or undesirable effect. The note attached to all new medicines (for five years) should include a red triangle and the note: "newly authorised medicine. Please inform of side effects". The notice will have the inclusion of a form to be filled in. Such a procedure already exists in the United States. Mrs Muller feels that the policy in terms of medicines, first concerns public health and should as a result be lead by the Commission Directorate General competent for health and the protection of consumers instead of being lead, as was the case until now, by the Directorate General for Industry. She also insists for the taking into account of the specific situation of small to medium sized companies.