Working together: how is the relationship with healthcare professionals regulated?
11.02.16
It is also a relationship that is changing constantly. In recent years, companies have placed less emphasis on sales representatives and calls, instead focusing on providing opportunities for peer-to-peer interactions with company medics and researchers. The way medical education is provided, clinical trial information is shared and the transparency of financial interests has all been subject to learning, change and development. It is a continuous process because it’s a relationship that we are committed to and we want to secure the basis for positive collaboration in the future.
Part of this process is the development of the legal and self-regulatory frameworks that guide interactions between industry and health professionals. All interactions with HCPs are governed by EU Directive 2001/83/EC on the Community Code relating to medicinal products for human use, the EFPIA HCP Code, as well as applicable EFPIA Member Associations’ national codes and any other applicable (local) internal policies, procedures and laws. In addition to complying with laws, regulations and codes of practice, companies will often have their own guiding principles to which they adhere.
Clinician time is often constrained and always valuable. Meetings with industry representatives are recognised as being a fast and effective way to stay up-to-date with information on the latest treatments but industry codes require these meetings to be appropriate in frequency, timing and duration.
Information provided to HCPs and healthcare organisations (HCOs) during these meetings and in any other context must be consistent with the Summary of Product Characteristics (SmPC). The SmPC is a legal document, approved by the regulator that governs the use of a medicine.
Industry and health professionals collaborate in a range of activities from clinical research to sharing best clinical practice and exchanging information on how new medicines fit into the patient pathway. When HCPs are employed by companies to provide consultancy services such as attending advisory Boards, speaking or chairing meetings then a number of strict rules apply. First of all there needs to be a legitimate need for the services, the services must be provided under a written contract, agreed in advance and compensation for the services must be reasonable.
Similarly, when companies provide support for an HCP to attend a medical education event, this support must be appropriate with the educational content of the meeting the primary focus. Any travel paid for by the company must be reasonable and in most circumstances is limited to economy. Meals are subject to national thresholds, applied in each country that limits the amount that can be spent on a meal. There are rules on the choice of accommodation, which must be in line with what an individual would reasonably chose if travelling independently. Venues whose primary purpose is entertainment or luxury hotels are not allowed. No gifts or pecuniary advantage can be provided to HCPs under any circumstances and no activities that can be considered an incentive to recommend, prescribe, purchase, supply, sell or administer a medicinal product are allowed.
A new era of transparency
In June 2016, companies will begin publicly disclosing payments made to health professionals for activities such as consultancy, Advisory Boards, speaking at meetings and support to attend medical education events such as travel and accommodation. Bringing greater transparency to this, already well-regulated, vital relationship is about strengthening the basis for collaboration in the future.
Relationships operating in the unique healthcare space of are critical, they impact of people’s lives, people’s health. The frameworks and new transparency requirements governing the relationship between industry and HCPs are designed to ensure that patients, healthcare systems and the innovative medicines industry can continue to benefit from working together in confidence.
For more information on disclosure of payments to health professionals, you can visit
http://beta.efpia.eu/relationships-codes/healthcare-professionals-hcps/disclosure/
