The European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI) has finally published the draft report on EU Options for Improving Access to Medicines. The draft report adds to the current debate on access to medicines going on at EU and national level, which accelerated over the past two years on the prices on new medicines. The draft report prepared by socialist MEP Soledad Cabezón Ruiz is largely based on the Recommendations for Better Access to Medicines of the Parliamentary Group of the Socialists and Democrats which was published earlier this year. It should be taken into consideration that an INI report only expresses the Parliament’s views on a topic and calls the European Commission and the Council to act, but is ultimately not binding on the Commission and Member States and in particular no legislative act.
The draft report especially criticises
- that prices for new medicines are in general too high and could not be afforded by patients and health care systems;
- the (mis-)use of the current patent system claiming that this would lead to a delay of the entry of generic products;
- the lack of transparency of the costs for the development of new medicines.
Consequently, the draft report calls for
- more transparency of drugs’ prices;
- more coordination on joint procurement and cooperation as regards price-setting procedures(in order to share information about prices, reimbursement etc.);
- rethink patenting rules: assumption that patents hinder innovation (OMPs among target medicines);
- increase of EU competences in the field of pricing mechanisms;
- a review the regulatory framework for orphan medicines.
Many points included in the draft, have already been addressed by the European Commission and the EU legislators. For example, in 2009 the Commission adopted the Final Report on its competition inquiry into the pharmaceutical sector. Since then, the Commission has been monitoring patent settlements between originator and generic companies and publishes annual reports. At the same time, the current system of data exclusivity and market exclusivity for medicinal products provides for a fair balance between the interests of originators and those of manufacturers of generics. Thus, many people do not see any need for the Commission or the Member States to act in this regard. Despite the many critical points, the debate in ENVI is also an opportunity to share positive messages on the existing legislative framework, for instance, highlighting the specificities and the importance of the OMP business model.
The next steps in the procedure are:
Exchange on the draft report within the ENVI Committee: 12-13 October
Deadline for amendments: 19 October
Vote in ENVI: 28 – 29 November
Vote in plenary session: January 2017, tbc
It is expected that the deadline for tabling amendments will be slightly extended due to the delay in publishing the draft.