Access to innovative medicines for all European patients can only be possible if clear framework conditions for pricing and reimbursement are set at a European Union level, according to Rolf Schwanitz, State Secretary at Germany’s Ministry of Health.

Health is one of the few pan-European sectors with vast growth potential, which is why Germany chose, as a key theme for its presidency of the EU, innovation in the pharmaceutical sector and specifically, personalised medicine, said Mr Schwanitz, speaking at a conference in Austria on June 29, two days before Germany handed over the presidency to Portugal.

Very important innovations in personalised medicines are expected in the near future but affordability is the crucial issue, he said. Therefore, he told the conference that, addressing the second High-Level Pharmaceutical Forum meeting in Brussels on June 26, German Health Minister Ulla Schmidt had stressed that it was not “affordable” for each EU member state to use a different definition of “innovation,” to attempt to find its own way of ensuring patient access to innovative medicines, or not to exchange information on the prices of these medicines with other member states.

Frustration at Forum's failures

Industry spokesmen have expressed frustration at the Forum’s failure to move forward in its three priority areas – pricing and reimbursement, relative effectiveness and information to patients. The initiative has failed to address its core objective and has instead become “another discussion platform on the cost of medicines, ” said Arthur Higgins, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and chief executive of Bayer HealthCare.

Nevertheless, progress reported at last week’s Brussels meeting included the Forum Working Group on Pricing and Innovation’s development of an “exhaustive list of valuable benefits than can be expected from innovative new medicines.” The group has also established nonbinding “toolbox” principles which, it says, will allow good implementation of pricing and reimbursement practices, covering:

– access for patients: to ensure timely access to valuable innovation, provide affordable medicines and ensure equal availability of medicines;

– optimal use of resources: to limit price control to where it is needed to contain the public budget, set up a consistent package of supply and demand-side measures and create the right environment for price competition;

– reward for innovation: to set expectations, recognise innovation and be consistent when giving rewards.

EU-level guidance on pricing and reimbursement is required urgently, said Mr Higgins, and he urged member states to consider a broad definition of value - encompassing therapeutic value, quality-of-life and socio-economic gains - in these decisions. He also called on them to endorse Recommendation 6 of the G10 (High-Level Group on Innovation and Provision of Medicines in the European Union) report, published May 2002, which states that: “the Commission and member states should secure the principle that a member state’s authority to regulate prices in the EU should extend only to those medicines purchased by, or reimbursed by, the state. Full competition should be allowed for medicines not reimbursed by state systems or medicines sold into private markets.”

Said Mr Higgins, “this single Recommendation, which could be rapidly implemented, would give companies the flexibility to provide more tailored solutions reflecting the economic situation of the different countries. “

Meantime, a draft working document reported by the Forum’s Working Group on Relative Effectiveness states that member states encounter “significant difficulties when undertaking assessments, particularly at early stages such as soon after marketing authorisations are granted”. It acknowledges that the pharmaceutical industry also encounters such difficulties, and stresses the potential for improving the generation, sharing and use data for relative effectiveness assessments at national level. The Group says it will focus on relative effectiveness assessments at this stage of its work, although cost-effectiveness issues will be considered later, if necessary.

However, Mr Higgins welcomed the European Commission’s statement that it has no intention of setting up pan-EU relative effectiveness assessment and the recognition that initial assessments are always provisional. “The lack of real-life data at the time of approval should not restrict or delay patient access and reimbursement of a product,” he commented.

Finally, the Working Group on Information to Patients reported that it has drawn up a set of Core Quality Principles for patient information on diseases and treatment options, which state that these should be: objective and unbiased; patient-oriented; evidence-based, up-to-date; reliable; understandable; accessible; transparent; relevant; and consistent with statutory information.

“Improved access to information will lead to better prevention and compliance, which will in turn result in more cost-effective healthcare,” said Mr Higgins, adding: “if we truly believe this, we should overcome the trust barrier and set ourselves a goal to have a new, comprehensive EU health information strategy by 2009.”

– An important initiative of the Portuguese presidency will be a major conference entitled Pharmaceutical Innovation: a new R&D strategy in the EU, to be held in Lisbon on November 19-20. The meeting will examine the current status of innovation in the EU and the USA, and discuss issues including the constraints, as well as the opportunities, for the current R&D model in the EU and ways in which public-private R&D partnerships can be established. By Lynne Taylor