Tags: Life Sciences
CJEU clarifies when reverse payment patent settlements can be anticompetitive
In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent and a manufacturer of generic medicines is contrary to EU competition law.
The DPA approves a draft Act prohibiting life and health insurers from processing health sensor data
The Belgian data protection authority has approved a draft Act that prohibits life and health insurers from processing the health sensor data of their insurance holders.
CJEU sheds light on the “Country of Origin” concept
In the run-up to the entry into force of specific rules on country of origin labelling for primary ingredients, the CJEU has recently clarified both the concept of the “country of origin” under the FIC Regulation and its interplay with other regulations such as the Regulation on the common organisation of the agricultural products markets and the Union Customs Code.
New Belgian Act on medicinal product shortages
On 3 February 2020, the Belgian Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Belgian State Gazette.
The new Plant Health Regulation is ready to take off as of 14 December 2019
Pests threaten plant health. To fight the increased risks owing to the further globalisation of trade and climate change, the European legislature has adopted measures concerning the determination and reduction of risks imposed by pests: Regulation 2016/2031.
Belgian Constitutional Court annuls new export prohibition for full-line wholesalers but new legislative proposals are already put forward
On 17 October 2019, the Belgian Constitutional Court annulled the export prohibition for wholesaler-distributors, which was introduced by Article 3, 2° of the Act concerning the unavailability of medicinal products of 7 April 2019.
Incentives and public procurement in the healthcare sector: be careful what you wish for!
Since the European Court of Justice’s ruling C-300/07 of 11 June 2009, hospitals and other health institutions must abide by public procurement law to the extent that they are at least 50% financed directly by public authorities or indirectly by public insurance schemes.
Towards a harmonised employee status by levelling up… Janssen Pharmaceutica sets an example
Very recently, a major player in the pharmaceutical sector, Janssen Pharmaceutica, has entered into a company CBA with the social partners that provides for full harmonisation between its blue-collar and white-collar employees, by abolishing the blue-collar worker status for all its workers from 1 October 2019.
New research exemption under Belgian patent law?
On 19 December 2017, the legislative package on the implementation of the UPC was approved by Belgian Parliament.
New rules to deal with the unavailability of medicinal products in Belgium
An Act of 7 April 2019 has introduced new measures in Belgium to deal with the unavailability of medicinal products on the Belgian market.
Companies beware! New prohibition in Belgium on the abuse of economic dependence
On 21 March 2019, the Federal Belgian Parliament adopted an Act amending the Code of Economic Law regarding abuses of economic dependence, prohibited terms and unfair market practices in B2B relationships.
Clinical Trials and the GDPR: do I really need the participant’s consent?
On 23 January 2019, the European Data Protection Board issued its Opinion 3/2019 on the interplay between the General Data Protection Regulation and the Clinical Trials Regulation.