Life Sciences Trends to Watch – Q4 2019

Life Sciences Trends to Watch – Q4 2019

Next in our sector-focused series - Life Sciences. We have spoken with our in-house PSLs to outline the key legal trends to watch in Life Sciences as 2019 draws to a close.

This article focuses on the following key trends: the shake up of regulation in medical devices, the new clinical trials regulation - and expected developments for 2020 - personalised medicine and big data, and cannabis based medicine.

Look out for similar 'Trends to Watch' articles from the series, focusing on different industry sectors and practice areas.

 

Shake up of regulation of medical devices

 

The regulation of medical devices has been overhauled and two new EU regulations, Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746, (the In Vitro Diagnostic Medical Device Regulation, IVDR) will apply from 26 May 2020 and 26 May 2022 respectively.

The reform was prompted by safety concerns relating to a number of devices, including some metal-on-metal hip implants and PIP breast implants, which highlighted gaps in the existing regime, as well as by recognition that the existing 20-year old regime was no longer fit for purpose given the significant technological advances in medical devices during that time. Such incidents also shed light on inconsistencies in the assessment methods of different certification bodies (known as Notified Bodies) and the need for more rigorous controls and monitoring of Notified Bodies by Member States, as well as the involvement of independent experts in the assessment of certain high risk devices. The new regulations therefore aim to improve the quality, safety and reliability of medical devices, strengthen transparency for consumers and enhance vigilance and market surveillance.

The new MDR and IVDR introduce significant changes to the medical device regulatory framework including extending the range of products that are subject to device regulation. This means that there will be many producers of previously unregulated products (eg, app developers and producers of aesthetic devices such as coloured contact lenses that do not correct vision) who are for the first time grapping with medical device regulation. The clock is ticking for all device manufacturers to ensure they are ready for the changes.

For more information, see Practice Note: An introduction to the regulation of medical devices—Reform of the EU framework

 

 

Will 2020 be the year that the new clinical trials regulation finally becomes applicable?

 

The way clinical trials are conducted in the EU will undergo a major change when Regulation (EU) No 536/2014 (the Clinical Trial Regulation, CTR) comes into application.

The existing regulatory framework on clinical trials has been widely criticised by stakeholders for being too fragmented and for having increased the regulatory burden and costs of conducting clinical trials in the EU, resulting in a significant decline in the number of trials conducted in the EU.

With the objective of re-establishing the EU’s competitiveness in the field of clinical research, the CTR introduces a single, harmonised regulatory regime that will apply to all clinical trials conducted in the EU, thereby hopefully cutting red tape for clinical trial sponsors. In particular, the CTR harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS, formerly the EU clinical trial portal and database). The CTR further aims at ensuring that clinical trial data are reliable and robust and that the rights, safety, dignity and well-being of subjects are respected throughout the EU.

The CTR was due to become applicable this year, however, delays in the development of the CTIS  (which is vital to its implementation), that the EMA have attributed to its relocation due to Brexit, mean that the Clinical Trials Regulation is now not expected to apply until 2020.

For more information, see Practice Note: The EU Clinical Trials Regulation

 

Personalised medicine, big data and AI

 

There is a lot of hype around the terms personalised medicine, big data and AI, but what does this actually mean for the life sciences sector?

Personalised medicine has existed for quite some time. Physicians have, to varying degrees, adapted treatments to individual patients based on information collected about them. But over the last decade and a half, the advent of systems biology has significantly widened the scope of personalised medicine, which in modern practice relies on acquiring as much data as possible about a given biological system.  As individualised genetic and genomic data becomes more readily available, healthcare systems are grappling with how such information can be used to prevent and treat disease. These massive accumulating stores of information are collectively referred to as ‘big data’, which researchers are beginning to interpret with the help of AI systems. Big data, moreover, will play an increasingly greater role in the development of personalised medicine research. The healthcare community will require new IT tools to manage patient data, including clinical information and lifestyle data. AI and its numerous medical applications are a major recent development and suggest a promising future. AI will contribute to facilitating this information access and more importantly will improve drastically data interpretation.

For more information about AI, see Practice Note: Artificial intelligence—introduction to the technology.

For more information about the data protection implications of big data in the life sciences sector, see Practice Notes: Conducting clinical research—data protection implications and mHealth—data protection considerations.

For more information on personalised medicine, see Practice Note: Personalised medicine – introduction to the technology

 

Cannabis-based medicines

 

The ability, for the first time, of doctors to legally prescribe cannabis-based products for medicinal purposes has hit the headlines in recent months. However, there remains a considerable amount of uncertainty as regards access to these medicines. This is mainly due to the lack of evidence about the long term safety and effectiveness of medicinal cannabis and the fact that most of them are unlicensed (which means that they have not been authorised by the medicines regulator). In addition NICE, the non-departmental public body which makes recommendations as to the appropriate treatment of specific diseases and conditions, has yet to finalise its guidance on the use of cannabis-based medicines following a public consultation which closed in September 2019. The guidance is expected to be published in November 2019. For more information, see Practice Note: Unlicensed medicinal products and off-label use of medicinal products and News Analysis: Lack of evidence base has led to low patient access to medicinal cannabis

You can follow all Life Sciences development here using the Life Sciences tracker.

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About the author:

Amy is an established writer and researcher, having contributed to publications, such as The Law Society, LPM, City A.M. and Financial IT. Her role at LexisNexis UK involved leading content and thought leadership, as well as writing research reports, including "The Bellwether Report 2020, Covid-19: The next chapter" and "Are medium-sized firms the change-makers in legal?"