In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe.  But what will this mean for companies who sell in-vitro-diagnostic medical devices (“IVDs”) in the UK?

Following the UK’s exit from the EU, the IVDR will not become effective within Great Britain (i.e., England, Scotland and Wales), but it will apply to Northern Ireland.  Companies operating in both the EU/Northern Ireland and Great Britain will therefore need to be aware of the different obligations applicable to IVDs between these jurisdictions.

IVDR Background

The IVDR will replace the existing EU IVD Directive (the “IVDD”), but will not change the fundamental principles of how IVDs are regulated.  IVDs will be still be subject to a system of self-certification, notified body assessment (in certain instances) and CE marking.  Most notably, under the current system, ~90% of IVDs are self-assessed for conformity and self-certified by the IVD’s manufacturer.  By contrast under the IVDR, the new classification rules mean that this will be flipped to require ~90% of IVDs to be subject to notified body assessment.  This creates practical issues for manufacturers, since there are currently only seven notified bodies who are authorized to conduct conformity assessments under the IVDR.Continue Reading What do companies supplying IVDs to the UK market need to know about the IVDR?

In collaboration with Corporate Law Group, New Delhi, India 

On December 16, 2021, India proposed amendments to the Biological Diversity Act, 2002 (the “BDA”) by introducing the Biological Diversity (Amendment) Bill, 2021 (the “Bill”).  The process to amend the BDA was undertaken in response to long-standing complaints by stakeholders in the Indian systems of medicine, seeds, and research sectors, as well as industry, that existing access and benefit-sharing (“ABS”) processes in relation to Indian biological resources are too burdensome.

The Bill has several objectives.  It seeks to attract foreign investment in Indian biological resources, to fast-track research, patent application processes, and transfer of research results, and to decriminalize non-compliance.  The Bill also seeks to further the conservation of biological resources in line with objectives of the Convention on Biological Diversity (“CBD”) and Nagoya Protocol to the CBD, to encourage cultivation of medicinal plants, and to support the Indian system of medicines.

The Bill’s proposed amendments are extensive and touch on many different aspects of ABS, but focus mainly on access and access procedures.  In this blog, we present the key proposed amendments, as well as next steps in the process for the adoption of the Bill.Continue Reading India To Amend Its Biodiversity Rules

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways for pharmaceutical companies.
Continue Reading Key Take-aways from the 150th Session of the WHO Executive Board

On 20 January 2022, the National Institute for Health and Care Excellence (NICE) announced major changes to the processes and methods by which it assesses the cost-effectiveness of medicines and other health technologies.

NICE is an independent expert body tasked with appraising the cost-effectiveness of medicines and recommending whether a product should be funded by the National Health Service (NHS).  NICE is therefore considered the gatekeeper for medicines reimbursement; a positive recommendation obliges the NHS to fund a product.

NICE has announced a suite of detailed changes, which mark the culmination of a two-year-plus long “methods review”.  NICE will implement the changes in new guidelines.  They are due to take effect from February 2022.Continue Reading UK Aims for Faster and Fairer Access to Innovative Treatments as NICE Announces Major Changes to its Health Technology Appraisals Process

The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022.  The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban specific biodegradable and compostable materials.  The Decree also imposes specific return obligations on waste plastic bottles. While the Italian Decree provides companies with additional flexibilities to market their SUPs in Italy, companies should carefully assess the risks that may arise if EU Courts finally hold that the Decree is not compatible with EU law.
Continue Reading Italy Transposes Into National Law The EU Single-Use Plastic Products Directive

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

Between 29 November and 1 December 2021, all member states of the World Health Organization (WHO) will convene for an extraordinary session of the World Health Assembly (WHA).  There is only one agenda item: whether or not to commence negotiations towards a legally binding, global instrument on pandemic preparedness and response.  Since it was first proposed by the European Union (EU) in November 2020, significant momentum has built towards some kind of International Pandemic Treaty (IPT).  The project is currently backed by the EU and more than 25 countries, though sceptics include the U.S., Russia, Brazil and China.

The IPT will be directly relevant to all pharmaceutical companies developing medical countermeasures (e.g. vaccines, diagnostics, and therapeutics) to most infectious diseases with epidemic or pandemic potential.  This blog summarizes key points that pharmaceutical companies should be aware of.Continue Reading Negotiations on a ‘Global Pandemic Treaty’ – What should Pharmaceutical Companies Expect?

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI and ML have the “potential to transform health care” through their ability to analyse vast amounts of data and learn from real-world use.  However, these technologies also pose unique challenges, given their complexity and the constantly evolving, data-driven nature of their development.  The Regulators formed the guiding principles to “help promote safe, effective, and high-quality medical devices that use . . . AI/ML” and to “cultivate future growth” in this fast paced field.

The Regulators predict that the guiding principles could be used to: (i) adopt good practices from other sectors; (ii) tailor these practices to the medical technology/healthcare sector; and (iii) create new practices specific to the medical technology/healthcare sector.  The Regulators expect these joint principles to inform broader international engagements as well.Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.”

Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software.  Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.

The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023.  This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized.  The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.

All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).Continue Reading Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports from Westminster bodies have proposed a new regulatory regime for so-called “nutraceuticals” (products that are part drug, part nutritional) to encourage investment.Continue Reading Growing calls for separate Nutraceutical regulation in the UK