EGA Press Release

Wednesday, 28 January 2009

EUROPE’S STRONGLY COMPETITIVE GENERIC MEDICINES INDUSTRY
WARNS OF INCREASING BURDENS AND HURDLES

Greg Perry, director general of the European Generic medicines Association, opened the 8th EGA Scientific and Regulatory Affairs Conference in Amsterdam today by highlighting his industry’s role in European healthcare and warning of increasing cost burdens and hurdles to competition.

“The generic medicines industry has become one of the most competitive sectors in Europe. As many as 30 companies may compete on a single product, resulting in major price reduction and savings for healthcare consumers. Generic medicines now account for nearly 50% of all medicines dispensed in the EU, but only make up 18% of pharmaceutical spending, which explains how generic medicines save EU patients €25 billion each year,” stated Mr Perry.

Generic medicines account for 70% of all applications under the Mutual Recognition Procedure, and 85% of applications under the Decentralised Procedure making the generic medicines industry the primary user of these European procedures.

But maintaining this level of competitiveness in future, Perry explained, will not depend entirely on the generic medicines industry. As highlighted in the recent preliminary report from DG Competition, the industry faces significant hurdles to market entry as a result of anti-competitive activities.

“In addition,” Mr Perry explained, “the growing economic pressures on healthcare budgets are also exerting further demands on generic companies and these pressures require corresponding efforts on the part of legislators and regulators to ensure both high volume generic competition and immediate access to generic competition after patent expiry.”

One major issue that must be solved is the current block on assessing new generic application caused by the lack of resources at the national medicines agencies to deal with growing demand. The so called “slot crisis” needs urgent action by Member States.

New European Commission proposals to combat falsified medicines must also acknowledge that generic medicines are not the target of counterfeiters and that to date there have been no reports of counterfeit generic medicines in the EU. The EGA has long supported legitimate efforts to eliminate the dangerous counterfeiting of medicines, but burdening generics manufacturers with regulations to solve a problem that does not exist in the EU generic medicines sector will only raise costs and prices.

Similarly, the EGA has worked closely with EU authorities for several years to strengthen the safety of Europe’s medicines by updating and enhancing current rules on pharmacovigilance. Mr Perry expressed confidence that “the new European Commission proposals will create a ‘win-win’ situation for Europe’s citizens, industry and regulators.” However, he said, “the EGA holds reservations on one aspect of the proposal that would require certain repetition of key information already provided to patients as potentially confusing and counterproductive to public health.”

Regarding European Commission proposals to liberalise industry information to patients, Mr Perry emphasised the EGA’s concerns over the possible misuse of that information as a marketing tool. It is crucial to the EGA that the new legislation ensures better—rather than simply more—information to patients in order to avoid any form of direct marketing and undue commercial influence over consumers.

The EGA conference is being held from Thursday 29 to Friday 30 January, bringing together industry representatives from 60 companies and some 40 regulators from 12 different medicines authorities from throughout Europe.

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