2007 Pharmaceutical Forum

Brussels, 26 June 2007 – The time has come for clear-cut decisions and concrete action if Europe wants to make a comeback as world leader in pharmaceutical innovation. This was the key message delivered today by Arthur J. Higgins, President of the European pharmaceutical industry association EFPIA and CEO of Bayer HealthCare AG, on the occasion of the second High Level Pharmaceutical Forum meeting in Brussels.

“The Forum has not met our expectations to date, as it hasn’t addressed its core objective, but has instead become another discussion platform on the cost of medicines, rather than their value and contribution to the health and wealth of Europe”, said Arthur. J. Higgins.

“My plea is that we focus on concrete deliverables” added Higgins “that will genuinely move the agenda forward - both at Community and Member-State level - for the benefit of patients, healthcare systems, and Europe’s competitiveness”.

More needs to be done in the three priority areas identified, namely: pricing & reimbursement, relative effectiveness and information to patients.

Pricing & reimbursement

Guidance at European level is urgently required for the pricing and reimbursement of medicines to ensure a better balance between the legitimate aim of national governments to contain healthcare expenditure; the right of European patients to the best available care; and providing the industry with a fair reward for research and innovation. Arthur Higgins urged Member States “to consider a broad definition of value in their pricing and reimbursement decisions, encompassing therapeutic value, quality-of-life and socio-economic gains”.

In addition, the industry pleads for an explicit endorsement of measures limiting the scope of price controls to medicines for use on the Member States’ own territory (G10 Recommendation 6). “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", stated Higgins.

Relative effectiveness

Greater transparency, quality and consistency are required in Health Technology Assessment systems across Europe. Arthur Higgins emphasized that EFPIA is committed to working with the Forum stakeholders towards the elaboration of a toolbox to provide support to Member States on methodologies, data use and coordination of HTA requests to industry.

He welcomed the clarification by the European Commission that it has no intention to set up a Pan-European relative effectiveness assessment and the recognition that initial assessments are always provisional in nature as they need data from real-life clinical practice. “The lack of data at the time of approval should not restrict or delay market access and reimbursement of a product”, he added.

Information to patients

The current lack of a modern Community framework for information about health and medicines hinders the right of European patients and citizens to access to quality health information. The pharmaceutical industry has unique drug and disease expertise and is ready to play a responsible role in the provision of non-promotional information, alongside healthcare professionals, pharmacists and regulatory bodies.

“Improved access to information will lead to better prevention and compliance, which will in turn result in more cost-effective healthcare”, said Arthur Higgins, “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”.