E-DRUG: Seizures of legitimate generics and DG Competition report
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Dear E-druggers,
I am happy to see that the recent posts from HAI Europe have generated fruitful discussion.
The seizures of legitimate generics in transit in the European Union are very controversial and represent a serious threat to access to essential medicines in developing countries. The position of the buyers/procurers (governments and health NGOs) has been to strongly condemn the seizures. Suppliers (generic manufacturers) are, obviously, not satisfied with the events. The Indian government has complained during the TRIPS council and also directly to the European Union.
As to the DG Competition Pharmaceutical Sector Inquiry and its recently published report, I would like to clarify that the document reflects an European perspective, as that is the remit of the European Commission. Hence, the recommendations contained in the paper should be read within that context. Any generic medicine that is on the market in the European Union has been authorized as such, and therefore meets regulatory standards for safety, efficacy and quality. In addition, in order to be considered a generic, it also meets bioequivalence criteria. So the concerns highlighted by some about quality issues are unfounded.
As to the role to be played by the prescribers, there is ample evidence that physicians' prescribing habits are influenced by drug promotion, a systematic review published in the Journal of the American Medical Association identified 29 studies published from 1994-1999 that examined the effects of interactions between physicians and the pharmaceutical industry and effects on knowledge, attitudes and behaviour (Wazana, 2000). More frequent contact with sales representatives was associated with higher prescribing costs, more rapid prescriptions of new medicines and less prescribing of generics.
In several countries of the EU, generic policies are already in place. These can contemplate encouraged and mandatory prescribing by active pharmaceutical ingredient; generic substitution by pharmacists; incentives for generic utilisation to prescribers, pharmacists and consumers; selective financing and pricing policies, among others. The recommendation contained in the DG Competition report to make generic substitution compulsory is not odd, nor even new, as it is already happening in Cyprus, Denmark, Italy and Sweden, where the pharmacist can substitute by the lowest priced equivalent, or by the cheapest or close to cheapest equivalent (Finland). In France, Hungary, Malta, Romania, Slovakia and Slovenia, there is voluntary generic substitution by pharmacists.
Bearing in mind the above what else is needed to go from recommendation to practice?
Will the stringent EU competition policy, which has been so instrumentally applied to other sectors in Europe, gather sufficient clout and political will to see compulsory generic substitution applied in all EU Member States?
Let us hope so, as it would benefit patients and consumers, and contribute to the sustainability of our health systems.
Kind Regards
Teresa Alves
Teresa Leonardo Alves
European Coordinator
Health Action International (HAI) Europe
Overtoom 60 II
1054 HK Amsterdam
The Netherlands
Mobile:+31 6 246 867 71
Tel: +31 20 489 1864
Fax: +31 20685 5002
Email:teresa@haiweb.org
Web site: http://www.haiweb.org/>
Health Action International (HAI) is an independent, global network working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy.