On the 2nd March 2020, the Medicines and Medical Devices Bill 2019-20 went through its second reading in parliament. It has been one of the first pieces of domestic legislation to be introduced since the Queen’s Speech in December 2019 and represents a critical area of post-Brexit regulatory change.
The Bill is politically uncontroversial. It passed first and second readings unopposed by the Labour Party and is more about the need for legislation to return regulatory powers to central government rather than a Brexit-fuelled political move.
Nevertheless, the legislation can define the medicines and medical devices regulatory environment for years to come.
Specifically, the legislation could have a significant impact on contract research organisations (CROs) whose interest is in stymying excessive divergence from US and EU clinical trial regulation. The following are just a few areas the bill might interfere:
The speed of approval processes for clinical trial applications
The UK has a reputation for world-leading standards in clinical research. It has several world-leading universities, research organisations, institutes and scientists operating around the ‘Golden Triangle’ (London, Cambridge and Oxford) and beyond. These hubs ensure pharmaceutical companies get the most out of phase I-III research, while also having applications approved quickly by the renowned Medicines and Healthcare products Regulatory Agency (MHRA). The combination of an effective and accessible regulator in the MHRA and its close relationship with NICE must be protected.
Alignment to the EU Clinical Trial Regulations (CTR)
The UK and, specifically, the Clinical Trials Unit of the MHRA played an active and leading role in the development of the EU Clinical Trial Regulations over the past five years – due for implementation during 2020. The regulations aim to create a single set of standards across the EU, establish a single method for submissions to assessment processes and increase transparency, collaboration and information sharing across EU Member States.
While the UK’s departure from the EU means that it won’t be implementing the regulations it helped to develop, CROs across the country will want to ensure that the future of the UK’s clinical research regulation is as closely aligned to the EU as possible. This will ensure its ability to deliver competitive, expeditious and high-quality research. The Medicines and Medical Devices Bill should facilitate this alignment.
The introduction of bureaucratic processes and regulatory burden for CROs
There is some anxiety in the CRO sector that the new regulatory environment will cause a significant bureaucratic burden when it comes to clinical trial applications. If the legislation oversees a divergence in regulatory standards and processes from other markets, applications to the MHRA could require more and different information to the U.S. Food and Drug Administration and the European Medicines Agency. CROs will be eager to mitigate this risk.
These are just a handful of areas where the Bill might affect CROs and the life sciences industry. Others include patient safety, pharmacies and medicine supply chains, as well as manufacturing, labelling and packaging.
by Ian Perrin