Industry heads speak out against new European hurdle
pharmafile | March 31, 2005 | News story | Sales and Marketing |
Two leading pharmaceutical executives have criticised European regulators for demanding that new treatments be compared with existing drugs before they are approved to market.
Daniel Vasella, chief executive of Novartis, said regulators should not stray away from using placebo controlled trials as the standard measurement of a drug.
Dr Vasella, speaking to the Financial Times, said: "If you make the hurdles too high, you may miss opportunities. We need to give patients more choice and doctors may find another drug works better and would prefer four or five choices to one or two."
His comments were aimed at the continuing difficulties the industry is experiencing with national regulators throughout Europe, where pricing and reimbursement decisions can be unnecessarily long, with frequent decisions to cut prices taken unilaterally by governments.
But the comments were made with particular reference to new pan-European pharma legislation, which was agreed a year ago and is now being translated into national law in the EU member states.
Article 60 of the new laws states that companies must demonstrate new products have 'added therapeutic value' over existing treatments before approval.
The industry has been steadfastly opposed to the idea, which is intended to discourage me-toos but which pharma says fails to recognise the value of different medicines in the same class in terms of clinical benefit as well as added competition.
Finland is one member state which has asked the European Commission's Pharmaceutical Committee how the new law should be interpreted, with the Commission now formulating its response.
Robert Ruffolo, head of research and development at Wyeth, agreed with Dr Vasella saying that "the Europeans have expanded their remit to social needs far beyond safety, efficacy, and risk-benefits. If you try to demand that every single drug is better, safer and brings more benefit than all the other, you'll never see another drug."
Despite his criticism, Vasella, like most other industry chiefs believes the development of an increasingly powerful EMEA will help Europe close the competitiveness gap with the US.
Vasella said the London-based agency has provided a clearer legal framework for the industry and has also "raised the level of scientific scrutiny" to satisfy public and political demand for strict pharmaceutical regulation.
The EMEA recently published its Road Map to 2010, a strategic document put together with stakeholders to turn the agency into an equivalent of the US' powerful FDA.
The greater centralisation of power is particularly necessary because of the expansion of the EU with ten new members, but also to provide faster access to medicine and greater post-marketing safety measures. Nurturing scientific excellence in the regulatory process in all therapy areas and improving access to information for patients and other key stakeholders is another key aim of the Road Map.
Speaking on this topic at the EMEA's tenth birthday celebrations, Dr Rodney Elgie, president of the European Patients' Forum highlighted the continuing lack of clear and independent information on prescription medicines in the EU. Plans by the Commission to allow limited communications between the industry and patients were thrown out in the drafting of the laws, with no clear framework in place for change.
"The fact remains that across all chronic diseases, compliance ranges from 40% to 60%. There is no disease area where compliance is 90%. Patients require more and better education in order to accept a greater degree of responsibility for the management of their illness and its treatment," he said.
Dr Elgie condemned the high wastage levels generated by poor compliance as "wholly unacceptable" citing an estimate by the Drug and Information Association that "the level of wastage in 2003 almost equalled the whole R&D budget of big pharma in that year."
Yet despite his call for improved patient information Dr Elgie paid tribute to the industry for ensuring that initial side-effects of drugs was a diminishing problem.
"Patients understand better today the mode of action of their medication and the fact that the body becomes used to the medicine's active ingredient."
He commended the EMEA for its recent reform to allow patient representatives onto its key management board.
"This was a brave move and some might claim an act of faith on their part," Dr Elgie noted, but said the move was appreciated by pan-European patient groups.
The agency also included in its Road Map the aim of helping stimulate research and innovation in the European industry, leading to the development of a roduct development toolkit
For more details on the EMEA Road Map visit: www.emea.eu.int.
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