European drugmakers have urged the European Commission not to revise current regulations covering the transparency of EU member states' decisions on drug pricing and reimbursement.
The call comes from the European Federation of Pharmaceutical Industries and Associations (EFPIA), in its response to the Commission's public consultation on its review of the Transparency Directive (Council Directive 89/105/EEC), the regulation which seeks to facilitate the free movement of medicines within the European Union (EU).
The Directive has not been amended since 1989, despite the substantial changes which have taken place in the EU pharmaceutical market since then, and the way forward could include a total revision of the Directive in order to establish a more modern set of rules, says the Commission.
However, in its submission, EFPIA questions whether a revision is the best way to address the issues which need to tackled, suggesting that many of them can be dealt with through a "soft law" approach, with the adoption of a Communication or Guidelines that would summarise past case law and provide practice guidance for the Directive's proper implementation.
In particular, says the Association, "it appears doubtful” whether revision of the Directive is capable of: - addressing healthcare and patient access challenges which relate to affordability and budgetary concerns of member states; - improving the competitiveness of the research-based pharmaceutical industry and providing better patient access to innovation in Europe; and - providing the right vehicle to implement the conclusions and recommendations adopted by the High-Level Pharmaceutical Forum in October 2008. These relate to improving information on diseases and treatments, comparing medicines and identifying those that are most effective, and balancing access and reward for innovation within limited healthcare budgets.
"Rather than engaging in a legislative project of revising the Transparency Directive, it appears more appropriate to focus on addressing the key challenges that the pharmaceutical industry faces today through dedicated legislation and other policy measures," says EFPIA.
R&D-based pharmaceutical companies are well aware of the constraints that EU member states are currently under and the pressures that come with making difficult funding decisions, and it is unavoidable that this will play an important role in member state views and actions during the review, said EFPIA director general Richard Bergstrom.
However, he added: “cost control in general and pharmaceutical price levels in particular must not dominate the review."
"We must remain focused on what the Directive has aimed to achieve over the years and ensure that its spirit, its contribution towards improving the mechanisms with which member states control pharmaceutical prices and reimbursement and how efficiently and speedily they grant access to patients remains, intact. If not, we risk taking two steps back instead of a step forwards better-functioning pharmaceutical markets and access to innovation," said Mr Bergstrom.
If the Commission does decide to reopen the Directive, EFPIA says it must be guided by core requirements for a balanced pricing and reimbursement environment, namely: - speedy access to innovations for patients; - predictable, objective and transparent processes; - clear value criteria and consistent, adequate reward for innovation; - good governance in systems that assess the value of medicines; - and member states' price controls to apply only to those products used within their territory.
"Funding challenges are the order of the day, but we need to think more strategically and ensure that cost concerns do not take over and act as a disincentive to innovation for patients. We need to find innovative solutions in partnership and enable more differentiated approaches to funding medicines," said Mr Bergstrom.
The public consultation closed on May 25.