Rachel Bradley

Regulatory update

by Rachel Bradley and Siobhan ffrench


Proposed Supplementary Protection Certificate regulations

Supplementary Protection Certificates (SPCs) enable pharmaceutical companies to extend their patent protection by a further 5 years to take the administrative and regulatory application time into consideration. The EU has proposed new regulations (which can be found here) to encourage ‘competitiveness within the EU’ and to create a level playing field between Union-based, and third country makers, of pharmaceuticals. The proposal is to allow manufacturers of generics and biosimilars to manufacture during the term of the SPCs for the exclusive purpose of exporting their products to non-EU markets where protection does not exist or has expired. In addition, the proposal would enable those manufacturers to make and store medicinal products for a defined period pending expiry of the SPC, helping those manufacturers to enter into the market of any member state of the EU on expiry of the corresponding certificate.

These regulations have been proposed and text agreed on 14 February 2019 so the updated regulations are due to come into force later this year. The new regulations are expected to generate €1 billion annually in net additional export sales and to create new jobs in the pharmaceutical industry.


New clinical trial regulations

The implementation of the new EU Clinical Trial Regulation is due to occur sometime later this year, with the new IT portal due to go live in 2020. It will be an important piece of legislation for all clinical trial providers. The purpose is to introduce a unified portal and database for sponsors and regulatory agencies across member states. This will allow for a streamlined application process and a single portal for all EU clinical trials. It also will ensure simplified reporting procedures which will help trials to be carried out across member states. Ultimately it will encourage transparency and make the process easier, facilitating quicker and more efficient trials.

As the UK has been heavily involved in the development of this new regulation it would be beneficial for the UK life sciences market for this to be implemented during a transition period so this can have effect in the UK. In any event, the UK government has confirmed that the UK regime post Brexit will aim to align with this new regulation. However, assuming that the UK does leave the EU, the UK will not have access to the central IT system or be able to take part in the single assessment model unless a deal is reached.


New medical device regulations

The EU Medical Devices Regulations and EU In Vitro Diagnostic Medical Device Regulation were adopted on 5 April 2017 but will not apply until 26 May 2020. These will replace the current directives for the regulation of devices and all manufacturers of medical devices should be aware of the potential implications to their business models.

The regulations are aimed at increasing the level of health and safety protection for EU citizens, and adapting to technological and scientific progress occurring in the sector. No existing requirements will be removed, but the new regulations will bring more stringent requirements and will apply to a broader range of products. A new device identification system will be implemented to enhance traceability and effectiveness of post marketing safety activities. The new rules will also provide increased transparency (not dissimilar to clinical trials) with information on devices and studies being made public.



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