Large-scale government tenders for generic medicines are threatening the future of the off-patent pharmaceuticals industry, the new president of the trade body has warned.

Mr Barret called for a “sustainable pricing system without which you create a downward spiral in which there are no limits”. He said large-scale tenders for medicines introduced by Germany and The Netherlands were undermining competition because many manufacturers refused to participate.

Mr Barret said if only those suppliers willing to bid for tenders at the lowest possible price remained the practice “could create pressure for reduced quality. Quality is guaranteed by regulators, but we must always remain vigilant.” However, he conceded there had been “rumours” concerning the quality of some generic medicines, and said there should be greater collaboration between regulators to inspect drugs and their raw materials within and imported into Europe.

Within the next three years, products going out of patent will reach a peak, both in number and value. In addition, biosimilar medicines will be confirmed as a new field for development. “If all conditions are met to allow generic and biosimilar medicines timely and fair access to the markets as put forward by the EC recommendations following the pharmaceutical sector inquiry, the potential is there to reshape the European healthcare landscape, be it in terms of patient access to medicines or savings for the healthcare systems” said Mr Barret.

Looking at legislative challenges ahead such as the pharmaceutical package, Mr Didier Barret called for pursuing cooperation with the relevant authorities and stakeholders. “With a new Parliament in place and soon a new Commission, it is now crucial to seize this opportunity to get the EU system right for the sake of all.”

Creating the conditions for a sustainable and competitive generics industry in the European market will be the main priority of his presidency, with a special focus on: (1) promoting sustainable generic medicines pricing systems;
 (2) granting automatic pricing and reimbursement status for generic medicines upon market authorisation while avoiding post-patent delays;
 (3) enforcing clear criteria for innovation, defined as synonymous with added relative therapeutic efficacy or safety, to eliminate evergreening practices;
 (4) fostering mechanisms to promote generics prescribing by physicians and generics dispensing by pharmacists;
 (5) creating the appropriate EU regulatory environment for generic and biosimilar medicines;
 and (6) continuing cooperation with the European Patent Office in raising the bar on patent applications.

Reference:

Andrew Jack. European group raises concern about government drug tenders. BIO SmartBrief. 2009 November 30, Financial Times. 2009 November 29.

“Stakes are higher than ever for the immediate three years ahead” says Mr Didier Barret newly elected president of the European Generic medicines Association (EGA). EGA press release. 2009 November 18.