Briefs & Briefing Documents

In addition to our tools and blog, ML&P occasionally delves into complex topics, posting brief explanations to make their legal implications more clear and understandable. We also undertake longer research projects, to more thoroughly explore issues and make policy recommendations. These are posted below.

Briefing Documents

An ML&P series of briefing documents that aims to contribute to the discussion on high medicines prices in Europe, in particular those that result from market exclusivity.

EU Review of Pharmaceutical Incentives:
Suggestions for Change

In June 2019, Medicines Law & Policy published a series of briefing documents that aim to contribute to the discussion on high medicines prices, in particular those that result from market exclusivity. The publication makes recommendations for policy and legislative change in the areas of Supplementary Protection Certificate, Data Exclusivity, and Orphan Medicinal Product regulations. The documents can be downloaded in their entirety, or by section, using the links below. A presentation on the documents made at a 3 June event co-hosted by the European Public Health Alliance is available here.

Briefs

CJEU Ruling on Truvada recalls ‘evergreening’ goes against public health interests

On 25th July 2018, the Court of Justice of the European Union (CJEU) rendered its preliminary ruling on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal...

Opmerkingen bij de notitie Dwanglicenties van B.J. Bruins, Minister voor Medische Zorg.

Op 15 juni 2018 stuurde Minister Bruins een notitie over dwanglicenties aan de Tweede Kamer. In deze briefing maken wij een aantal voorlopige opmerkingen op de notitie van de Minister. Vragen en opmerkingen zijn...

How patents, data exclusivity and SPCs interact to extend market exclusivity of medicines: the...

Patents usually confer 20-year exclusive rights on inventions. Data exclusivity laws confer, depending on the country, 5 to 10 years’ exclusive rights over safety and efficacy data submitted for the registration of new medicines...

Brazil’s Federal Court Reviews Medicines Mailbox Patents

This week the media reported that the Brazilian federal court removed the patent protection for eculizumab, sold under the brand name Soliris by Alexion Pharmaceuticals Inc.  Eculizumab is used in the treatment of paroxysmal...