The “Global Compliance Congress”, held in Munich in November 2015, was an opportunity to make a review of expectations in terms of transparency, the constraints related to the implementation of such practices and to identify trends emerging among the different European countries.
In the Nordic countries (Sweden, the Netherlands), the disclosure of financial transactions with healthcare professionals is satisfactory, unlike in other European countries such as Poland, which did not receive the expected support the from healthcare professionals (less than 23% of Polish doctors are willing to give their consent for the disclosure of the amounts invested for them by pharma companies).
The Standing Committee of European Doctors representative Katrín Fjeldsted, emphasized the need to maintain and even to accentuate the often already initiated dialogues between healthcare professionals and the industry, reminding HCPs that the latter is a major vector of information and training for healthcare professionals, as well as a source of funding for scientific research.
It is also necessary to raise awareness on the issue of transparency to make the public understand that the development of new drugs needs more and more investment and that the money is invested in research, information and education.
The participation of Ben Morgan from the Serious Fraud Office in the UK, has also helped shine light on financial and image risks for pharma companies if they do not comply with the transparency requirements.
Marie-Claire Pickaert, from the EFPIA, introduced the implementation steps of the self-regulatory guidelines recommended by the EFPIA in response to the growing demands of Europe. The EFPIA would like to include clinical trials in the transparency requirements, while respecting the privacy of patients.
Among the best practices to implement for the establishment of a successful transparency policy include:
- Clearly definethe scopein thecompanies’ subsidiaries:processes analysis,approvalprocedures, financial data to integrate and the existing solutionsto interface.
- Putthe complianceissuesat the heart ofpharma companies’ stakes.
- Havelocal intermediariesto manage
- Integratewarning systemsto preventdeviations fromregulatory requirementsor internal
Some challenges in the implementation of these guidelines were discussed:
Which regulations must member companies of EFPIA follow, when there is a local regulation in place? The EFPIA integrates national specificities in its code.
The collection of consents
While several participants raised the increasing difficulty for their companies to collect consents, the EFPIA nevertheless recommends to collect them, for instance through contracts signed with healthcare professionals. According to the applicable law, pharma companies may be required to obtain this consent.
Finally, Laurent Clerc, Regulatory Affairs Expert for BMI SYSTEM, concluded this conference by emphasizing the challenges rising from the implementation of measures to monitor transparency. This may also prove to be a real opportunity to hamonize and optimize processes, payments and compliance policies within pharma companies.