Press Release Revised Transparency Directive seeks to improve patient access but more is needed by Member States

Europes pharmaceutical industry welcomes the Commission proposal for a revised Transparency Directive but calls on European Institutions to set up the debate on solidarity among Member States on pharmaceuticals.
Brussels, 1st March 2012: The Commission proposal for a revised Transparency Directive published today will improve Member States procedural framework for pricing and reimbursement of medicines to accelerate patient access to innovation. In the current difficult economic context in Europe, however, more needs to be done to ensure fair access for all EU patients to pharmaceutical treatment. EFPIA Director General Richard Bergstrm says: This proposal is a welcome step in the right direction to address some of the procedural shortcomings in national pricing and reimbursement systems. It respects Member States competence in healthcare. Further steps are needed to tackle the challenges to patient access to medicines. The proposal maintains the core principles of the existing Directive and adapts it to reflect judgments by the Court of Justice of the European Union. In particular EFPIA welcomes the following steps toward faster patient access to the medicines they need: Shorter maximum time limits for completing and publishing pricing and reimbursement decisions. The transparency requirements to include all measures that control or promote the prescription of specific medicines. No re-assessment of any regulatory approval data which may have caused delays in the past. Improved enforcement through creation of a remedies procedure in case of non-compliance with the time-limits, dialogue with stakeholders and regular monitoring of implementation. Richard Bergstrm adds: Improving access to medicines is a complex challenge requiring a joint response from the Commission, Member States and industry. Europe must continue to incentivize and reward innovation. Industry wants to make sure that products are available, but this requires solidarity among Member States. The practice of international price referencing prevents differential pricing between markets - something that is standard in other parts of the world where it is not only accepted but indeed welcomed that companies charge lower prices in low- and middle-income countries. In Europe too, access to medicines could be improved for patients if governments embraced differential pricing. Especially in times of economic crisis, the focus of Member States on pricing measures such as international or therapeutic reference pricing poses a threat to the long-term innovative capability of Europe and hinders access to medicines. This is even more worrying if emergency price cuts under exceptional circumstances such as in Greece lead to automatic and arbitrary price cuts in 15 other Member States, Richard Bergstrm concludes. The pharmaceutical industry across Europe is working with the European Commission, Member States and international institutions to ensure that pharmaceuticals support patient needs in countries in difficult economic times. ***
Leopold Plaza Building Rue du Trne 108 Bote 1 B-1050 Bruxelles T +32 2 626 25 55 F +32 2 626 25 66 www.efpia.eu

European Federation of Pharmaceutical Industries and Associations

Contact Richard Bergstrm Tel: +32 (0)2 626 2555

Useful links EFPIA Memorandum on the Review of Directive 89/105/EEC www.efpia.eu

About EFPIA: EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 35 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europes ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe. The pharmaceutical sector directly employs some 640,000 people in Europe including 115,000 working in research and development in 2010. The industry also generates around three to four times more employment both upstream and downstream. Europes research-based pharmaceutical industry generates a substantial trade surplus, estimated at about 46,800 million in 2010, and has contributed significantly to reducing the European Unions trade deficit in high-tech products. 27,000 million were spent on research and development in Europe in 2010. Almost a quarter of the EUs high-tech exports are pharmaceutical products.

Fdration Europenne dAssociations et dIndustries Pharmaceutiques

Leopold Plaza Building Rue du Trne 108 Bote 1 B-1050 Bruxelles

T +32 2 626 25 55 F +32 2 626 25 66 www.efpia.eu