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European Pharmaceutical Contractor
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The accession of 10 new European States on 1st May, coincidentally on the same day as the implementation of the EU Clinical Trials Directive, will mean new opportunities as well as pitfalls for companies undertaking clinical research projects. This article explores these possibilities and issues, with particular reference to clinical trials supply, and examines whether the expansion of Europe will make it more or less attractive as a clinical research venue. Concern has been expressed in recent years about the decline of clinical research in Europe.
A recent report from Cap Gemini Ernst and Young indicated that growth in pharmaceutical research and development in Europe was only 50 per cent of that in the US (1). However, Europe continues to be the second largest pharmaceutical market worldwide, with sales of around $100 billion and an important clinical research base. Will the accession of 10 new member states improve the climate for research and will the implementation of the EU Clinical Trials Directive in Europe help or hinder that process? A number of the accession countries have been used increasingly since the mid-1990s as attractive clinical research venues; in particular Poland, the Czech Republic and Hungary. More recently, other countries such as the Slovak Republic, Slovenia and the Baltic States have joined their ranks.
The reasons are well-rehearsed: the prevalence of disease and the availability of drug-naïve populations; the treatment of patients in large outpatient clinics; the good standards of medical education; and the high ratio of doctors per capita of population. Movement of clinical supplies into these regions, however, has not always been easy, and differing regulatory requirements, the need for import licences and customs hurdles, have sometimes proved difficult.
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