Drugmakers have broadly welcomed the final recommendations of the three-year investigation by the European Commission’s Pharmaceutical Forum into challenges confronting the sector, but say they have failed to address vital issues such as maintaining the price levels for products set by individual European Union (EU) member states.

Currently, parallel imports mean that attempts by the industry to offer preferential pricing to poorer EU nations are “paralysed” by the “non extra-territoriality of member state price controls,” said Arthur Higgins, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The Forum examined challenges in three areas: how to improve information to patients on diseases and treatments (see PharmaTimes October 3 for its conclusions and stakeholder reaction); how to compare medicines and identify those which are most effective; and how to balance access and reward for innovation within limited health care budgets.

Discussing the group’s recommendations on pricing and reimbursement – which include the adoption of guiding principles to help national authorities find a balance between expenditure, access and innovation - Mr Higgins said that implementing these principles, limiting price controls to nationally-used volumes and broadening the definition of “value” when making pricing and reimbursement decisions is “a necessary step.”

Equally important, he added, will be implementing the recommendations in the area of relatively effectiveness assessment, or Health Technology Assessment (HTA). These call for the drawing-up of working definitions and good practice principles, a “stocktaking” of existing methods and a common analysis of existing technical and legal barriers to the development of relevant data. The industry is fully supportive of, and wiling to participate in, any network which would increase the quality and consistency of HTA systems across Europe, said Mr Higgins, who is chief executive of Bayer HealthCare.

“At a time when the European pharmaceutical market is witnessing increasing volatility and patients in Europe need more than ever access to new medicines, it is actions not words that are needed if we are to bring Europe back to the forefront of pharmaceutical innovation,” he emphasised.

Also dissatisfied were the generics makers, who urged EU regulators to take steps to guarantee patient access to generics “at day one” after patent expiry. In some cases, the first generic only enters the market as late at 20 months after the patent has expired, said Eric Gorka, president of the European Generics medicines Association (EGA).

He called on the Commission and member states to remove all anti-competitive barriers to immediate post-patent market entry for generics, especially “patent linkage, ” ie, attempts to link a product’s authorization and price/reimbursement status with its patent status. Another cause of delay is that EU governments spend many months after market authorization before granting a price or substitution status to a generic “despite its lower price and well-known use,” added Mr Gorka.

Biotech calls for “predictable environment” in EU

EuropaBio, which represents small and medium-sized enterprises (SME), mainly biotechnology health care firms, welcomed the Forum’s conclusions but also called on the EU to do more to support its members which, it said, “are led by some of the most innovative and brightest scientists in Europe, who need a predictable long-term framework in which to anchor their research and to attract investment to Europe.”

Andrea Rappagliosi, chairman of EuropaBio’s Healthcare Council, stressed the need for all stakeholders to be involved in decisions, especially those related to relative effectiveness and pricing/reimbursement, in order to avoid what he called “short-sighted and budget-driven healthcare” decisions which “inhibit patient access to the best innovation.”

- Commission Vice-President Commissioner for Enterprise and Industry Guenter Verheugen, who co-chaired the Forum with Health Commission Androulla Vassiliou, forecast that that the group’s recommendations will lead to important savings and permit a better reward for innovation. Added Commissioner Vassiliou: “patients deserve prompt and equal access to the best medicinal products available, and EU cooperation on the relative effectiveness of drugs will help achieve that goal. I also welcome the concrete recommendations on information to patients on diseases and treatments as a major contribution to EU public health promotion policy.”