The evolution of the regulatory context in the healthcare industry has been continuous, especially over the last 3 years. An example of this can be seen in the approval of FENIN’s ethical code (the Spanish Federation of Medical Device Companies), on December 20th 2016. FENIN has now integrated the MEDTECH requirements (European Association of Medical Device sector) of the December 2015 version of the Ethical Code of business Practices.
With this update, the Medical Device sector in Spain is gaining ground towards meeting the most advanced transparency contexts already in place in the Pharmaceutical industry. Indeed, from an ethical point of view, the pharmaceutical and medical device sectors are inherently linked and should apply the same transparency guidelines as they concern the same commercial relationships and share the same objective, which is to guarantee the well-being and health of the patient.
Although there are many similarities between FENIN and FARMAINDUSTRIA’s (pharmaceutical industry) respective ethics codes, there remains one fundamental difference. In FARMAINDUSTRIA’s case, disclosure is required at the individual level for HCPs (for 2018 disclosure). FENIN requests only the aggregated publication of the ToVs made to HCOs.
A key difference with EFPIA disclosure is that the Medical Device sector will no longer be able to directly sponsor HCP invitations to congresses and events. Such sponsorships will need to be made through healthcare organizations, which will be in charge of selecting the HCPs who will attend these events on behalf of the Medical Device manufacturer.
Finally, FENIN has proposed granting a certification or stamp of adhesion to compliant companies that organize educational events, in order to attest to their commitment to the ethical code. Moreover, FENIN itself will publish the list of certified suppliers on its website.
The main challenge facing the Medical Device industry will be to face the short implementation deadlines for these new requirements since the first disclosure will take place in 2018. The first disclosure will report the ToVs made in 2017 and therefore will require companies to optimize and track all of their interactions with HCPs and HCOs as of January, 2017. Experience from the implementation of transparency in the Pharmaceutical sector demonstrates that this represents a significant challenge.