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European Pharmaceutical Contractor

Editor’s Letter

2012 has seen a number of changes in the pharmaceutical industry, including here at Samedan Ltd. We are very sorry to see our Managing Editor John White leave and wish him every success. However, we are excited to welcome on board Rupert Gilbey.

I wouldn’t normally think that bribery would be a topic of importance to a magazine such as EPC; however, I have to reconsider that opinion in light of the recently introduced Bribery Act 2010, as Laurent Clerc at BMI SYSTEM and Steven Gray at Compliance Hub explain in this issue (page 16). It is an Act of the UK Parliament that covers the criminal law relating to bribery and as such has an impact on all industries. The relationship between industry and health professionals, in the context of medical education, continues to be raised by various stakeholders as a point of reputational vulnerability for all of those involved and the introduction of the Bribery Act tightens control of financial relationships. “Where does education become promotion and promotion become incentivisation to prescribe?” ask Laurent and Steven. Hospitality is a clear issue in the Bribery Act and in the ABPI Code; it is why guidance must be issued for all employees. They conclude that “the next big challenge for the pharmaceutical industry will not be to find a global solution for compliance and bribery issues in all its subsidiaries, but to cope with different local compliance standards and at the same time guarantee that these different standards comply with extraterritorial transparency requirements.”

The pharmaceutical industry in Japan has not exactly been headline news of late, apart from the takeover of Nycomed by Takeda in 2011. The current scene in Japan has been reviewed by Geetika Munjal of GBI Research, who notes that Japan is the second largest market globally for pharmaceuticals (page 66). However, with the emergence of China this may not last for long. The review discusses the key players, drug pricing, regulatory trends and the key issues in the market, concluding that with increasing pressure on the Japanese government to cut down on healthcare costs, the health ministry is focused on increasing the generic share above 30 per cent. This increase, coupled with the upcoming patent expirations, is expected to create opportunities for generic drug manufacturers. On the other hand, pharmaceutical companies are increasing their R&D investments in order to tap underserved disease areas. Regulatory reforms, including an improved drug approval process, are expected to attract further investment.

2012 saw the new proposals for the revision to the Clinical Trials Directive in Europe. One of the driving forces behind this revision is a fall in the amount of clinical research that is presently being carried out here. Karyn Korieth and Annick Anderson of CenterWatch report a nine per cent decrease in the number of investigators during the past five years as sites struggled with regulatory burdens and unprecedented economic challenges caused by the European financial crisis (page 42). Now that the crisis has lessened somewhat and the new Directive is expected to ease the regulatory burden, the authors see encouraging signs of financial recovery. So, perhaps we shall see the return of trials to Europe, possibly being encouraged by new initiatives in risk based monitoring, as discussed by Rick Morrison of Comprehend Systems (page 38).

I’m sure you will agree with me that there is plenty on offer in this issue of EPC; well done to Jenny for helping to assemble an interesting and thought-provoking edition.

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Graham Hughes, EPC Editor
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