With the review of the EU "Transparency Directive" (Directive 89/105/EEC) gaining momentum, improving the competitive environment for pharmaceuticals and strengthening access to innovation for patients must remain core objectives in the review's next steps.
Adopted more than 20 years ago, the Directive has made an important contribution to improving member states' provisions controlling pharmaceutical expenditure towards better objectivity and transparency of processes. The Directive also sets a mandatory timeline for pricing and reimbursement decisions which has been a key element in considerably improving waiting times for patients for reimbursed treatments across Europe. Its review by the European Commission comes at a time when increasing budgetary concerns by member states, further heightened by the financial crisis, weigh down heavily on healthcare systems, and pharmaceutical budgets in particular.
On the occasion of the closing of the European Commission's public consultation today, EFPIA Director General Richard Bergström stressed that the R&D-based pharmaceutical industry is well-aware of the constraints that member states are currently under and the pressures that come with making difficult funding decisions. Unavoidably, this will play an important role in member state views and actions during the review. However, cost-control in general and pharmaceutical price levels in particular must not dominate the review. He said:
"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 forward towards better functioning pharmaceutical markets and access to innovation. "
The European Commission includes an actual reopening of the Transparency Directive as a possible outcome of the review, alongside an interpretative Communication. While supporting the latter which would clarify relevant Court of Justice jurisprudence, EFPIA urges in its submission that if the Commission decides to reopen the Directive, it must be guided by core requirements for a balanced pricing and reimbursement environment:
- Speedy access to innovations for patients
- Predictable, objective and transparent processes
- Clear value criteria and consistent and adequate reward for innovation
- Good governance in systems that assess the value of medicines
- Member States‟ price controls to apply only to those products used within their territory
"We all have a role to play in making sure that the review, whatever its outcome, will ultimately benefit the environment for pharmaceuticals in Europe. 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 and access for patients. We need to find innovative solutions in partnership and enable more differentiated approaches to funding medicines", said Richard Bergström.
Source:
EFPIA