Latest news on Pharmaceuticals from the European Commission
Recently, the Commission has publisheed a progress report on medicines for children covering the five years since the Paediatric Regulation came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals. An inverted triangle will shortly appear on the inside leaflet of certain medicinal products on the EU market, following a legal act adopted by the European Commission today. The symbol will allow patients and health care professionals to easily identify medicinal products that are undergoing additional monitoring, and its accompanying text will encourage them to report unexpected adverse reactions through national reporting systems. A secure alert platform launched by the European Commission will improve the safety of patients undergoing transplantation and medical procedures involving human tissues and cells, e.g. bone marrow, cornea, skin, oocytes, sperm, etc. National health authorities can use the web-based Rapid Alert system for Tissues and Cells (RATC) in case of alerts relating to human tissues or cells transferred across borders. Timely exchange of urgent information between Member States can ensure that cross-border incidents are prevented or contained and immediate measures taken to ensure the safety of patients. The RATC will be used in parallel with existing national vigilance systems which collect and manage alerts on tissues and cells donated and used within a Member State. Medicines should enter the market faster. With this intention the European Commission has proposed today to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines. In the future, such decisions should be taken within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180 days today. Commission also proposes strong enforcement measures in case the decisions do not comply with the time limits, as these are often exceeded by Member States. The European Commission has launched a public consultation in view of modernising rules on the transparency of Member States’ decisions regarding the pricing and reimbursement of medicines. The consultation invites all interested parties to share their views on the review of Council Directive 89/105/EEC, often referred to as the 'transparency directive'. The Innovative Medicines Initiative (IMI) is a public-private partnership aiming to improve the drug development process. The European Commission's Seventh Framework Programme contributes EUR 1 billion to the IMI research programme. That amount will be matched by mainly in kind contributions (consisting mostly of research activities) worth at least another EUR 1 billion from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA). On the occasion of the Belgian Presidency's ministerial conference on innovation and solidarity in the field of pharmaceuticals, Commission Vice-President Antonio Tajani announced the launch of a process on corporate responsibility in the pharmaceutical industry. A distinction is made between three platforms - (1) ethics and transparency (2) access to medicines in Africa and (3) access to medicines in Europe - and will examine the major challenges of access to medicines in Europe and Africa in the light of the issues of price and reimbursement.