All the MEPs in the European Parliament’s environment and public health committee have acknowledged that the difficulty of accessing certain medicines in Europe is a subject of concern.
The right and left of the political spectrum are, however, largely divided over the way to resolve the situation, as borne out by the debate held on 12 October.
At the core of this discussion is the question of the own initiative report by Soledad Cabezón Ruiz MEP (S&D, Spain) on the European Union’s options for improving access to medicines. In this report, Cabezón Ruiz denounces the exorbitant prices for innovative medicines, such as Sovaldi – for which the patent was partially invalidated by the European Patents Office last week. Sovaldi is sold for approximately €50,000 to patients for a three month hepatitis C treatment. Following the debate, the rapporteur stated that "in OECD countries, 20% of health spending goes on medicines, 80% of which come from public funds. There is therefore a problem involving the sustainability of health systems".
The draft report will be put to a vote at the end of November (28 or 29) and calls for a comprehensive overhaul of the current system, given that the systems for setting prices and reimbursements are covered by the member states. The report suggests that action be taken with regard to the authorisation mechanisms, competition rules and support for research.
Cabezón Ruiz recommends, for example, that the Commission introduce the concept of authorisation being conditional on levels of efficiency. She also calls for strict limits to be defined in the area of intellectual property (IP) and for non-exclusivity (or co-ownership of IP) to be supported for projects financed through EU subsidies, as well as for improved definitions of the abuse of dominant position due to high prices. At a legislative level, the rapporteur calls on the Commission to review the regulatory framework for orphan medicines, to promote legislation on evaluating medical technologies, and to put forward a new directive on the transparency of price setting procedures and reimbursement systems.
These proposals provoked an angry response from the EPP and ALDE Groups, however. Frédérique Ries (ALDE, Belgium) did not beat about the bush, stating: "I am surprised about the tone of this report, which identifies a situation but which has been drafted in haste… I hope that it will be amended”. By contrast, the GUE/NGL and Greens/EFA Groups backed the report. Michèle Rivasi (Greens/EFA, France) stated that "the market does not regulate anything", and highlighted the fact that the pharmaceutical industry was a "flourishing and competitive industry that was less and less innovative".
The deadline for submitting amendments is 19 October. In total, five parliamentary committees are due to submit their respective opinions: DEVE, INTA, EMPL, JURI and PETI. The report can be consulted at: http://urlz.fr/4dcN (Original version in French by Sophie Petitjean)