Pharmaceuticals

UK High Court orders pre-action delivery up of samples for infringement testing and considers use in other jurisdictions

Rafi Allos

In Boehringer Ingelheim v Generics,* the English High Court ordered the rarely-used remedy of pre-action inspection of property, for the purpose of allowing experiments needed to assess patent infringement. The case provides a useful reminder of the powers of the Court in this area, as well as providing a reference as to how the Court Read More

Dutch antitrust watchdog publishes additional notification requirements for healthcare mergers

Iradj Nazaryar

The Dutch Authority for Consumers and Markets (ACM) has published a new method of analysing product markets in merger investigations with respect to specialised medical care. In this context, the ACM requires merging hospitals and independent treatment centres to provide more detailed information in their merger notifications to the ACM. The starting point for the Read More

French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine

Jeanne Fabre

The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for Read More

Positive outcomes of third evaluation of Dutch Act on Medical Research involving Human Subjects

Anna-Maria Withagen

On 9 January 2019, the Dutch Minister of Health, Welfare and Sports published its report evaluating, for the third time, the Dutch Act on Medical Research involving Human Subjects (WMO). According to the report, the overall functioning of the WMO is satisfactory. As per the evaluation, the goal of the WMO, which is to protect Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of Read More