Pharmaceutical Executive Europe - February 2008 - (Page 22)

22 Regulatory Affairs Credible Compliance Linda Horton takes a global look at some of the issues that are set to affect compliance in the coming year. ompliance problems, as we all know, can tarnish the reputation of companies and the value of their brands. Restoring both a good name, and the customer’s trust, can take years. Executives have to pay attention to compliance and they know that, even for foreign operations, out of sight is not out of mind. In many companies, country managers once operated mini-fiefdoms. Today, however, many companies have decided that there is a need for certain top-down controls in the compliance arena. Otherwise, the legal, publicity and damage-to-brand risks presented by compliance failures are simply too great. C 2008 and beyond One of the pharma trends in the coming year and beyond is more attention to clinical trial compliance issues. At present, most companies have compliance plans and standard operating procedures (SOPs) governing both marketing practice compliance and relationships with healthcare professionals (HCPs). Clinical trials do not have as many clear guideposts, and certainly not the array of codes of practice seen at the post-market stage. Outside the US, there is little guidance for drug companies on relationships with clinical investigators and hospitals in a trial context. Sometimes, contract research organisations (CROs) will suggest a range of ‘incentives’ to motivate investigators to speed up enrolment of human subjects. Or they might ask for certain benefits, such as sponsorship to a medical conference. There is a general rule in the International Conference on Harmonisation (ICH) guidance on Good Clinical Practices that all financial arrangements in a trial must be disclosed to the Ethics Committee (Institutional Review Board). However, for trial sites outside the US, there is generally little other guidance on what assistance to a clinical investigator (equipment, training, reimbursement for travel to conferences and so on) is permissible. Bribery. Another trend to watch is increased attention to healthcare ‘bribery.’ There has recently been an explosion of interest in the relevance of the US Foreign Corrupt Practices Act (FCPA) and other countries’ anti-bribery laws to drug companies’ relationships with HCPs who are either employed by foreign governments or who practice medicine in public hospitals. Whether it is a clinical trial agreement, a consulting arrangement, a market research study or speaker training, the stakes are higher when dealing with a government doctor. Certainly the entire area of bribery in the healthcare sector will continue to receive a great deal of attention. Code revision. Pharmaceutical companies’ operations are still implementing the 2006 revision of the marketing practices code of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). But now all European operations must once again adapt their practices, this time to match the 2007 version of the code of the European Federation of Pharmaceutical Industry and Associations (EFPIA).

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - February 2008

Pharmaceutical Executive Europe - February 2008
From the Editor
News and Analysis
Brussels Report
R&D: Innovation - Learning to Share
Drug Launch - The Preparation Game
Q&A - Getting a Head Start
Regulatory Compliance - Credible Compliance
Clinical Trials - Establishing Trials in China
The Mix - Relevant ROI
Comment - Taming the Trader
Last Word - Under the Microscope

Pharmaceutical Executive Europe - February 2008