Brussels, 25/09/2006 (Agence Europe) - Following the parliamentary committee's rejection of the Mikolasik report (EUROPE 9266), it is highly unlikely that the European Parliament will be able to conclude its first reading of the draft regulation on the authorisation of innovative therapies before February 2007. The main patient associations and the pharmaceutical industry, represented by the European Biopharmaceutical Enterprises (EBE), deplores this additional delay. Although some people think that it is preferable to take the report to a plenary for introducing any corrections, other quarters consider, however, that it would be better to begin the work again in the parliamentary committee.
In its elaboration of its proposal, the Commission was fully aware of the ethical obstacles that could be raised during a centralised authorisation procedure for new gene, cell and tissue therapies. It also took care to point out a subsidiarity clause in Article 28 that allows Member States to refuse the marketing of advanced therapy medicinal products on their territories. To this end, it drew on Article 4 of the 2003 directive on medicines for human use, which allows for Member States to refuse the marketing of contraceptive or abortive products in their countries. Unfortunately, too generalised editing of this article, swiftly led to it being questioned by Parliament's legal services. In an opinion submitted at the request of the president of the environment committee, German Christian Democrat, Karl-Heinz Florenz, the legal service underlined that the draft regulation is based on Article 95 of the Treaty, which allows for the free movement of goods and that a clause that enabled Member States to put obstacles in its way would be contrary to the objective being pursued. Consequently, the legal service said that it would explain how Member States that rejected the regulation had to be motivated by questions that are not tackled in the regulation or other connected Community legislation. This amendment was included in an amendment by German Social Democrat Dagmar Roth-Behrendt, which was rejected in the committee, amid a moment of pronounced confusion. In the follow-up, the more conservative MEPs refused to approve a series of apparently inoffensive ethical amendments but which could seriously hold up the development of the new therapies. The first of them raised some extremely old fears that evoked the danger of delusional and hybrid therapies, which would almost be laughable if it did not threaten the whole range of research based on the hope of using biological materials taken from animals and xenoplantation. The second focuses on the non-commercialisation of the human body and is subsequent body parts. The principle is widely acknowledged and entirely accepted when obtaining these parts for transfusion or transplants. But the industry is afraid that its introduction in this text could block the development of some therapies. It also underlines that this regulation focuses on products that are recognisable by the nature (use of a manufacturing process) of the cell or tissue or the human organ removed for transplants. The industry considers that the approach chosen by the parliamentary committee for modifying the germ line is too restrictive and could lead to significant delays to patient access for certain therapies. In view of the vote on the amendments to the Mikolasik report, MEPs are for the instant supporting a ban on therapies that lead to modification of the germ line, except for certain diseases. It is true that this could be amended in accordance with scientific progress but the list of exceptions will therefore have to be revised each time. According to the industry, it would be better if a mechanism were introduced that would make the authorisation of intervention subject to the germ line of a “substantial therapeutic advantage”.