Members of the European Parliament's Committee on the Environment and Public Health (ENVI) made significant changes, on 18 December 2012, to the draft directive on the transparency of measures governing decisions on the pricing of medicines. The rapporteur, Antonyia Parvanova (ALDE, Bulgaria), explains that this is justified by the need to take account of the situation of member states' competent authorities.
The main innovation in the reform proposed by the Commission is the shortening of time limits for pricing decisions. By voting to maintain the existing time limits, what is left of the proposal? Was a revision even necessary?
The ENVI committee maintains the 180-day limit [90 for pricing plus 90 for reimbursement decisions, compared with 60 plus 60 proposed by the EU executive - Ed] for innovative medicines, but adds new elements to facilitate effective and practical implementation of these deadlines. The goal is to have a realistic common framework that can be complied with in the Union on time limits for decisions on pricing and reimbursement of medicines. In its impact study, the Commission demonstrated that in many cases the existing limit of 180 days was not being respected. What's more, our vote supports the principle of a shorter time limit for generic drugs, and this is a new provision not found in existing legislation. Faster access to generic drugs means more affordable treatments for patients, but above all substantial savings for the financial balance of national health care systems.
The Council also seems inclined to make substantial changes to the proposal. Is it fair to say that the Commission got it all wrong?
The impact study conducted by the Commission showed that the existing legislative framework, adopted over 20 years ago, was not being applied appropriately and no longer corresponds to today's reality in terms of access to medicines and the working of national health care systems. So in that respect, the Commission was right to present a new legislative proposal, especially because it included some of the recommendations of the pharmaceutical sector inquiry conducted by DG Competition in 2007. On the other hand, there is no doubt that it failed to give enough consideration to the concrete situation of pricing and reimbursement authorities in member states. Both Parliament and the Council consider some of these proposals disproportionate to the aims sought. In my opinion, there are still many positive elements...