The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals.

摘要

BACKGROUND: Relationships between the pharmaceutical industry and healthcare professionals continue to drive discussion about the potential for conflicts of interest. Despite greater regulation and oversight, there are still calls for increased transparency and further restrictions on these relationships. Regulatory authorities, the pharmaceutical industry, professional societies, and other interested parties have responded by developing robust guidelines for interactions between the pharmaceutical industry and healthcare professionals. This, in turn, is driving change in the way that healthcare communications agencies work, increasing the need for them to visibly demonstrate processes that ensure their employees comply with relevant laws, regulations, and guidelines. EXPOSITION: In our group of healthcare communications agencies we have established an internal compliance program and developed a policy that reflects the services we provide, and we recommend that other agencies adopt a similar program. Compliance training, implemented by a nominated compliance team, can be enforced by including compulsory tests for employees who interact with the pharmaceutical industry and healthcare professionals, with annual reassessment. The compliance team also has an important role to play in ensuring ongoing communication and staff education, including awareness of new legal and best practice developments. Management of the compliance program is essential, with clear mechanisms for auditing and evaluation, and the inclusion of compliance adherence in staff performance objectives. A visible framework for handling potential compliance issues should also be developed, with clear definitions of different levels of noncompliance and potential associated consequences. Compliance programs may also include other elements, such as terminology and documentation guidance, so that the program becomes an integral tool used by employees on a daily basis. CONCLUSION: With a robust internal compliance program, healthcare communication agencies can play a significant role in helping maintain appropriate pharmaceutical industry-healthcare professional relationships in an increasingly regulated and scrutinized environment.