Information on medicines: Conspicuously absent
By Ophélie Spanneut and Sophie Petitjean | Thursday 12 July 2012
The pricing of medicines, specific foods, clinical trials and medical devices are the key health subjects to be discussed during the Cyprus Presidency. The noteworthy absence is information on medicines. Nicosia has decided not to address this issue, which member states roundly condemn for the limited added value of the draft directive and regulation and the potentially high implementing costs. The new EU Council Presidency may try to work out an agreement with Parliament on the draft regulation on foods for infants and young children and on foods for special medical purposes (revision of Parnuts - food for particular nutritional uses - Directive).
It is also set to begin work on the directive to improve the transparency of measures regulating the prices of medicines for human use. The Commission wishes to shorten deadlines, obliging public authorities to hand down decisions more quickly on prices and reimbursement of medicines to prevent them hindering the proper working of the single market. Published in March 2012, the text has been discussed in the Council’s working group, but the road ahead looks difficult.
Two national parliaments have adopted a reasoned opinion arguing that the proposal infringes the subsidiarity principle. The Austrian chamber points out that the directive interferes with member states’ right to organise their social security systems. Luxembourg’s MPs consider that it unilaterally gives precedence to the interests of the pharmaceutical industry. These two opinions suggest that debates will be heated in Council. A Cypriot official commented that this is a “difficult matter because of possible intervention in national public health systems”. The European Parliament’s rapporteur is finalising the draft report that will be debated by members of the Committee on the Environment (ENVI) towards mid-September.
The Commission is set to present a number of new proposals that will fuel the co-legislators’ work. First, there will be a proposal, in July, on clinical trials. The challenge will apparently be to strike a balance between the need for transparency, safeguard of personal data and laboratories’ commercial interests. The Cyprus Presidency has planned a July meeting with the Commission on this subject, which will also be discussed at a Council sitting.
Work on medical devices will probably start up this autumn with presentation of a proposal for revision of the regulatory framework. Despite this late adoption, Cyprus intends to reserve two working meetings for this issue. It will be on the agenda of a Council of Ministers before the end of the Presidency. A Cypriot official explained that the safety of medical devices and patient protection both need to be improved. An EP resolution, adopted on 14 June in the wake of the scandal of the defective breast implants manufactured by the French firm PIP, anticipated these discussions. MEPs called on the Commission to change the current certification system so as to set up prior marketing authorisation for high-risk and invasive devices.
The Commission is slated to revise the directive on tobacco products towards the end of 2012 and to decide whether or not to maintain its idea of introducing neutral cigarette packaging across the EU.
The Cyprus Presidency wishes to propose conclusions to the health ministers on organ donation, active ageing and innovative approaches to health. A conference is planned on the latter theme in October.