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2004 is set to be a year to remember for Europe. In May, 10 new countries will be joining the European Union, and this expansion will have far reaching consequences in many areas. At the same time, European pharmaceutical legislation is undergoing reform, and in particular the areas of patent protection and 'biosimilarity' are being discussed throughout the pharmaceutical and biotechnology industries. And let's not forget that the EU Clinical Trials Directive is scheduled to be implemented via national law on 1st May - as of December only three countries (Denmark, Sweden and Italy) had transposed the Directive into law. There are also calls to repeal the Directive from non-commercial research organisations, as it will place 'insurmountable' obstacles in their way (Scrip 21st Jan 2004). It looks like an interesting year ahead.
It was hoped that the Directive would harmonise the regulatory requirements for conducting clinical trials throughout Europe, and while it achieves this in some ways - for example each country must have a positive approval process for clinical trials - the transposition into national laws will mean that there will still be differences between the countries of Europe. It will also be interesting to see how the accession countries have framed the Directive in their laws, as these countries are increasingly being considered as targets for clinical trials.
Another country being considered as a location for clinical trials is India. At the end of last year I visited India and was invited to present at a workshop on clinical data management at the University of Pune. In what proved to be a fascinating meeting, I was encouraged by the evident enthusiasm of those working to develop relevant skills in India. There is undoubtedly a huge opportunity for clinical research in India: not only is there a large patient population, but there is also an increasing number of contract organisations developing the ability to access the population. |
