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The Pharmaceutical Journal Vol 266 No 7154 p888-891
June 30, 2001

Letters

Medicines promotions Primary care pharmacy Diabetes Veterinary medicines Mutual recognition Code of Ethics Checking technicians Disillusioned youth Martindale Letters to the Editor	Mutual recognition MRAs should benefit patients, not importers From Mr J. Sharp, Hon MRPharmS John Turner’s clarification (PJ, June 9, p787) of the mutual recognition agreement (MRA) between the European Union (and hence the United Kingdom) and Japan leaves a number of important questions unanswered. As Mr Turner, writing on behalf of the Medicines Control Agency, correctly states: “It is the standard of manufacturing practice and official inspections which it is intended will be mutually recognised as equivalent.” He adds that this recognition will come into effect “only after the successful completion of an evaluation exercise, it is hoped, by 2003”. By virtue of our membership of the EU we are already party to a similar “mutual recognition” with all the other member states. We are also party to a precisely similar MRA with the United States. Yet, and these are the crucial points, as Mr Turner and his colleagues must undoubtedly be aware, manufacturing standards in many of the member states of the EU are way below those that would be considered acceptable in Britain. “Official standards” of inspection in some of these member states are often, at best, perfunctory. Furthermore, despite the awesome (not to say draconian) reputation of the US Food and Drug Administration on its excursions away from its home patch, manufacturing standards in US pharmaceutical factories are often well below the acceptable, as well. Again, Mr Turner and his colleagues must be fully aware of this. The MCA owes British pharmacists and other health care professionals, the British public and British patients an assurance that, this time, it will do a better job of ensuring “equivalence”. Mr Turner writes of the “benefits” of these MRAs to UK importers. Should not the benefits to UK patients be the prime consideration? John Sharp Woodley, Berkshire

	JOHN TURNER replies: The process which is being followed for evaluating the equivalence of the regulatory systems of potential MRA partners is thorough and rigorous. It is set out in the text and guidance of the agreements available on the websites of the European Commission and European Medicines Evaluation Agency. The MCA continues to play a major role in these processes so that British pharmacists, other health care professionals and the public can continue to be assured of the quality, safety and efficacy of medicines. Mr Sharp’s opinions on the relative standards in Europe and the United States are interesting — but are opinions. In our experience there is, regrettably, variability in standards of manufacture in all countries, and regulators in all endeavour to minimise this variability and remove any which fall below what is acceptable.
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