Latest Developments on the Competition & Regulation Environment in the Pharma Industry

/ / Legal x-rays, Media & Events

I recently attended the annual EU Pharma Law Forum in Brussels at the 14th & 15th of May, 2014. Competition issues in the Pharma Industry have been key discussion points among EU officials and international law firms. Also highlighted was –once more- the intense regulation in the pharma business that creates high costs in authorization, billing, refunds, intellectual property, and hinders critically larger R&D investments in comparison to other sectors.


Pharma companies

Recent decisions in the broader system of European Justice against a pharmaceutical company for “abusing its dominant position” were mentioned. In that case, falsified product information was submitted to the Intellectual Property Organization. The Company was sentenced and was forced to re-register its first-generation capsule products in order to be prohibited from engaging in the generic manufacturing and parallel trade market. In other cases, companies were charged for artificially maintaining high prices and therefore, delay the introduction of some generics in the broader market. There has been, however, an increasing tendency for compromise at the courts on issues of patent litigation, in the last decade.


Parallel Trade

On the prevalent issue of parallel trade, it was agreed that Germany has positioned itself as a parallel imports pioneer. Many other countries such as the Netherlands, Denmark and Sweden, follow Germany’s lead. Consequently, South-Eastern European countries such as Greece often face themselves with major drug shortages. The question was raised again during the conference on whether patient or commercial interests (through parallel trade) should prevail. Recent decisions of the European Justice system were examined. In one, a multinational pharmaceutical company was accused of reducing the supply quantity of a particular formula in both France and Spain in order to prevent parallel trade. The Court ruled that by applying a unilateral company policy – however accepted by its wholesalers, who continued to cooperate – did not raise a legal question according to the Article 101 of the European Regulation.


How about then adopting a corporate policy, in order to reduce quantities of imported products destined for parallel export (“on reasonable and adequate levels”, as prescribed by the domestic market) in defense of corporate commercial interests? Greece was mentioned as one of the countries which, within the last 18 months, adopted new legislation to address drug shortages. The issue of parallel trade is expected thereon to be reviewed by the new Commissioner for Economic and Monetary Affairs of the European Union, who will replace Mr. Joaquin Almounia.



This year, important emphasis has been given to the relationship between Health Care Professionals and pharmaceutical companies, vis-à-vis the evolving International and European legislation. Recent stark changes in transparency regulation were observed; more specifically, on the legality of HCPs’ participation in scientific events and on the benefits publicizing by the pharmaceutical companies. In the case of Greece, the Hellenic Association of Pharmaceutical Companies (SFEE), complying with the above, has inserted even newer modifications and altogether original and retrospective provisions to its Code for the promotion of prescription-only medicinal products.


Pharmaceutical Marketing & Advertising – Social Media & Health apps

Of particular interest has been the seminar on the new challenges faced by pharmaceutical companies to promote their formulas through social media, applications (apps), especially under the strict regulatory framework currently governing them. The flexibility given to the pharmaceutical companies to benefit from new promotional tools (e-detailing) and platforms and the legal issues which have been raised due to the variety of simultaneous legal jurisdictions and corresponding regulations attracted notable attention.



As a founding member of Michalopoulou & Associates LawGroup, I consider the work and conclusions of the conference particularly important for adopting new competition law practices, resolving intellectual property matters and dealing with current generic and compliance issues by the pharmaceutical companies and the industry in general.


In particular, pharmaceutical companies should pay attention to the following:

  • There’s a need to adopt corporate practices that effectively address parallel trade,
  • Promotional methods for end-of-protection pharmaceuticals,
  • There’s a need to address compliance issues head-on, both in tune with the provisions of the internal corporate Code of Ethics and the governing Greek, European and International legislation – especially in relation to every company’s transactions with health professionals,
  • An explicit in-house approval process in respect to the promotion of corporate formulas through social media and mobile/desktop apps and their use by patients or HCP should be implemented now, before any effort to even draft a marketing plan.


 Published on Pharma Journal on June 10 2014