Pharmaceutical Executive Europe - February 2008 - (Page 23) Pharmaceutical Executive Europe February 2008 Regulatory Affairs 23 Notably, the EFPIA revised code expanded its coverage of scientific and educational activities — the last version had focused on promotional activities as well as rules for hospitality at both promotional and educational meetings. One change that may make life simpler for companies is the provision stating that any funding to sponsor an HCP’s attendance at an international congress is subject to the rules of the jurisdiction where the HCP carries out his/her profession, rather than the rules of the jurisdiction where the event takes place. Before, the disparities between the PhRMA code’s limits on sponsorships for mere attendance at meetings — and the European code’s permitting such sponsorships — had created confusion in the frequently occuring situation in which a multi-national drug company is sponsoring a European doctor to attend a medical congress in the US. Under the revised code, sponsorship to attend a medical congress must be in compliance with the laws and relevant codes of the country where a doctor practices. It is not simply enough, however, to issue policies and to train people. Companies also must take steps to assess the extent to which business conduct conforms to compliance standards. This is best accomplished through a system of monitoring and auditing. Monitoring and auditing serve to assure there is no gap between the plan and the reality. And there is need for consequences: an effective plan can help ensure that any improper conduct contrary to established written policy is isolated. The better the procedures to implement the policies, the more likely that violations will involve instances of falsification or other forms of deceit by employees seeking to circumvent the policy. Typically, such a fact pattern puts an organisation in a much stronger position to address any questions from outside parties such as government bodies or trade code groups. The critical consideration is whether the organisation responds to violations in a way that is consistent with its overall compliance objectives. One aspect of a response is the application of appropriate discipline commensurate with the violation. Compliance plans and procedures Without a doubt, the foundation for any compliance plan is the issuance of standards and policies to guide business conduct. Company policies need to use language and examples that can be readily understood by the business people who have to follow them. Creation of a compliance plan is not primarily a drafting exercise to write down some ideal policies and then publish them. This seemingly common-sense and straightforward approach is, in fact, academic and idealistic. It can create organisational standards, without taking steps at the same time to change behaviour and internal norms. In the event of a problem, the gap between what the company says it does, and what its employees in fact do, can result in an enforcement nightmare — bad conduct as well as bad documents. So you, as an executive, can set the tone by showing those who work for you that compliance is a non-negotiable priority. At the same time, avoid compliance plans that are unrealistic and unachievable. A better and more pragmatic approach begins with an assessment of the organisation’s current understanding and approach to regulatory compliance, and building on that. Many company compliance programmes establish risk-based priorities. A company code needs to be strictest on bribery issues, kickbacks, waste of public healthcare funds and tax evasion, as well as classic regulatory concerns including off-label claims, hospitality, congresses and payments to doctors. Executives and compliance professionals need to particularly watch out for situations where there could be accusations that a company's payments (or other benefits it provided) might have influenced the choice of products by public healthcare systems. Credible compliance To have credibility, disciplinary procedures must include everyone who participated in the violation in a material way, not just lower level employees. Also, the organisation needs to learn from its problems by taking steps to understand why and how the violation occured and identify changes in the procedures to avoid recurrences. Finally, the organisation must determine whether the violation is of a type and scope to warrant some form of disclosure to regulators. About the Author Linda Horton is a partner in the Washington and Brussels offices of Hogan & Hartson (LRHorton@hhlaw.com)
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - February 2008 Pharmaceutical Executive Europe - February 2008 Contents From the Editor News and Analysis Brussels Report Calendar 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 Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 1) Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 2) Pharmaceutical Executive Europe - February 2008 - Contents (Page 3) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 8) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 9) Pharmaceutical Executive Europe - February 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 11) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 12) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 13) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 14) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 15) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 16) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 17) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 18) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 19) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 20) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 21) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 22) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 23) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 24) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 25) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 26) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 27) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 28) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 29) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 30) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 31) Pharmaceutical Executive Europe - February 2008 - Comment - Taming the Trader (Page 32) Pharmaceutical Executive Europe - February 2008 - Last Word - Under the Microscope (Page 33)
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