Common market but divergent regulatory practices: exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products

Abstract

The medical product sector is characterised by a regulatory patchwork of European and national laws and guidelines operating concurrently with each other. Each of these sectors are characterised by different levels of regulatory uncertainty that may undermine the effectiveness of the regulatory framework. How have European regulation shaped individual product sectors? How has that impacted regulatory uncertainty in that sector? What has been the impact of regulatory compliance? Drawing on documentary research and fieldwork interviews this pilot study conducted in Netherlands, finds that ATMPs and medical device sectors exhibit high level of regulatory uncertainty. Although the sources of uncertainty are varied across each of the sectors. In some instances when regulatory uncertainty have reached unmanageable levels, measures have been taken by regulators to address it. Regulatees themselves have developed a complex compliance strategy that allows them to tolerate and in certain circumstances even circumvent regulatory uncertainty.

Keywords:

• Regulation
• medical device
• pharmaceutical
• ATMPs
• regulatory uncertainty
• compliance

Notes

1. The Transparency Directive of 1989, established European guidelines for national authorities while setting up their own pricing and reimbursement policies. Despite this being the only initiative, member states fear an expansion of similar steps at the European level.

2. The criteria of classification is based on the perception of interviewees. Although there have been European regulations in all the three sectors, in the case of pharmaceuticals it has enabled harmonization, whereas in the case of medical devices and ATMPs it has met with limited success in facilitating harmonization.

3. It should be noted that when the study was done, the term RECAST was officially used by the European Commission to refer to the process of legislative changes that was under discussion with references to the medical device directives. However, since then, the European Commission (at the end of 2011) stated that the term RECAST creates an incorrect allusion to the nature of amendment of the directives, They preferred using the term ‘revision’, since the changes being considered could lead to fundamental changes in the regulatory structure of medical devices in Europe.