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THE MEDICINES AND MEDICAL DEVICES ACT 2021: STATED AIMS AND SIGNIFICANCE

The Medicines and Medical Devices Act 2021 (MMDA) became law when it received Royal Assent on 11 February 2021.  The MMDA can be viewed here:

https://www.legislation.gov.uk/ukpga/2021/3/pdfs/ukpga_20210003_en.pdf

Its stated aims included the following:

  • establishing a Patient Safety Commissioner, with the core duty of promoting patient safety in relation to the regulation of human medicines and medical devices;
  • introducing targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the UK’s departure from the EU;
  • providing “information sharing gateways” to enabling sharing of information with regulators outside the UK in order to give effect to international agreements and arrangements for the regulation of human medicines, veterinary medicines and medical devices;
  • providing a delegated power to establish information systems in relation to medical devices;
  • providing a delegated power to establish, on a legislative basis, a medical device expert advisory committee; and
  • consolidating the enforcement provisions for medical devices and introduction of civil sanctions.

Why is the MMDA important? By far and away the most important provisions of the MMDA relate to the powers given to the UK to depart from the EU regulatory framework in order to give effect to the end of the Brexit transition period and to allow relatively easy amendment of existing UK laws and regulations through secondary legislation, known as statutory instruments.

Statutory instruments often receive less legislative scrutiny than primary legislation. The MMD Bill had a controversial path through parliament with Lord Blencathra describing, in the second reading in the House of Lords, the future powers of delegation as “absolutely atrocious and an affront to parliamentary democracy”. 

What will be absolutely key for the currently globally-leading life science sector will be the detail set out in future statutory instruments which have not yet been published, but which industry observers believe might be fairly soon.  Whether the life sciences sector benefits from “slashing red tape” to make the UK an even more attractive place to do life sciences business, as the government hopes, or whether there is, as detractors fear, a “race to the bottom” in terms of a rapid move away from EU regulatory standards remains to be seen. It’s a matter of watch this space.Whatever happens, it’s bound to be an interesting time for the industry.

Prospect Law will publish an update when the draft statutory instrument is published.

About the Author

David McIntosh was admitted as a Solicitor in 1988 and is a highly experienced commercial projects lawyer who has advised clients in a number of different fields including intellectual property, data privacy, procurement law (both public and private), manufacturing, distribution, information governance and general regulatory matters covering both the nuclear and pharmaceutical sectors.

Prospect Law is a multi-disciplinary practice with specialist expertise in the energy, infrastructure and natural resources sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and other technical experts.

This article remains the copyright property of Prospect Law Ltd and Prospect Advisory Ltd and neither the article nor any part of it may be published or copied without the prior written permission of the directors of Prospect Law and Prospect Advisory.

This article is not intended to constitute legal or other professional advice and it should not be relied on in any way.

For more information and/or advice on the impact of the MMDA on your business, please contact dmc@prospectlaw.co.uk or by phone on +44 (0)7940 204 948.

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EUROPEAN COMMISSION ASSERTS JURISDICTION TO REVIEW MERGER OF TWO US CORPORATIONS – ILLUMINA INC. FILES ANNULMENT SUIT IN RESPONSE.

Prospect Law Life Sciences – Article 22, EU Merger Regulation 139/2204

Illumina Inc’s proposed acquisition of Grail Inc, which it had spun out in 2016, has raised potential competition issues on both sides of the Atlantic and will also be of interest to companies in the life sciences sector.

Illumina, based in California, is a global genomics company and a leading supplier of next generation sequencing systems for genetic and genomic analysis. GRAIL, also based in the US, is a healthcare company which develops cancer detection tests relying on next generation sequencing systems.

The story begins on March 30, 2021 when the US Federal Trade Commission announced that it had “filed an administrative complaint and authorized a federal court lawsuit to block Illumina’s $7.1 billion proposed acquisition of Grail—a maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Illumina is the only provider of DNA sequencing that is a viable option for these multi-cancers early detection, or MCED, tests in the United States”.

Then on April 20, 2021 the European Commission announced that it had accepted the requests submitted by Belgium, France, Greece, Iceland, the Netherlands, and Norway to assess the proposed acquisition of GRAIL by Illumina under the EU Merger Regulation (PDF).

The proposed acquisition did not reach the notification thresholds set out in the EU Merger Regulation, and it was not notified in any Member State.

France submitted a referral request to the Commission pursuant to Article 22(1) of the EU Merger Regulation. This provision allows Member States to request the Commission to examine a merger that does not meet national or EU thresholds and therefore does not have an EU dimension but affects trade within the single market and threatens to significantly affect competition within the territory of the Member States making the request.  

On the basis of the information provided by France and the other countries, and without prejudice to the outcome of its investigation, the Commission considers that the transaction meets the criteria for referral under the Article 22. In particular, the combined entity could restrict access to or increase prices of next generation sequencers and reagents to the detriment of GRAIL’s rivals active in genomic cancer tests following the transaction. A referral of this transaction is appropriate because GRAIL’s competitive significance is not reflected in its turnover, as notably evidenced by the USD 7.1 billion-dollar deal value. Genomic cancer tests, having the potential to identify a wide variety of cancers in asymptomatic patients, are expected to be game-changers in the fight against cancer. It is therefore important to ensure that patients get access to this technology as quickly as possible, from as wide sources as possible, and at a fair price.

Subsequently on April 29, 2021: SAN DIEGO–(BUSINESS WIRE) — Illumina, Inc. (NASDAQ: ILMN) announced today that it has filed an action in the General Court of the European Union asking for annulment of the European Commission’s decision asserting jurisdiction to review Illumina’s acquisition of GRAIL. The Commission asserted jurisdiction to review the acquisition under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced.

“The European Commission’s unprecedented and untimely decision to review this procompetitive acquisition without proper engagement with the parties leaves businesses uncertain as to how the EU Merger Regulation will be applied,” said Charles Dadswell, Senior Vice President and General Counsel for Illumina. “The Commission’s actions will stifle innovation, fail patients and increase healthcare costs by needlessly delaying this transaction. The acquisition will allow Illumina to bring GRAIL’s lifesaving testing to more patients, more quickly and at a lower cost.”

While the Court process is ongoing, Illumina will continue to work with the European Commission’s Directorate-General for Competition to bring the review to a conclusion as quickly as possible”.

WHAT HAPPENS NEXT?

Actions for annulment enable the Court to review the legality of acts adopted by European institutions, including the Commission. The Court may annul the act concerned if it is judged to be contrary to European Union law based on the grounds of: (i) lack of competence; (ii) infringement of an essential procedural requirement; (iii) infringement of the Treaties or of any rule of law relating to their application, or misuse of powers.

Key to the outcome may involve an assessment of the Commission’s own Guidance on Article 22 and a consideration of the views of Executive Vice-President Margrethe Vestager in her speech on “The Future of merger control”.

Prospect Law will publish an update when the outcome of the annulment action is known.

About the Author

David McIntosh was admitted as a Solicitor in 1988 and is a highly experienced commercial projects lawyer who has advised clients in a number of different fields including intellectual property, data privacy, procurement law (both public and private), manufacturing, distribution, information governance and general regulatory matters covering both the nuclear and pharmaceutical sectors.

Prospect Law is a multi-disciplinary practice with specialist expertise in the energy, infrastructure and natural resources sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and other technical experts.

This article remains the copyright property of Prospect Law Ltd and Prospect Advisory Ltd and neither the article nor any part of it may be published or copied without the prior written permission of the directors of Prospect Law and Prospect Advisory.

This article is not intended to constitute legal or other professional advice and it should not be relied on in any way.

For more information and/or advice on the content of this article or impact on your business, please contact dmc@prospectlaw.co.uk or by phone on +44 (0)7483 300 132.

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REVISED PHARMACEUTICAL INDUSTRY CODE OF PRACTICE ON PROMOTING MEDICINES TO HEALTH PROFESSIONALS: A BRIEF SUMMARY OF THE ABPI CODE DUE TO COME INTO FORCE IN JULY 2021

After consultation with members and stakeholders, the Code of Practice 2021 has been agreed.  The current version from 2019 will be replaced by the 2021 version with effect from 1 July 2021.

The ABPI Code of Practice, administered by the Prescription Medicines Code of Practice Authority on behalf of the ABPI, has regulated the promotion of medicines by pharmaceutical companies to health professionals since 1958.  Since the writer’s first involvement in the life science and pharmaceutical industry in 1988, the Code has been amended more than a dozen times. 

The objectives behind the latest revisions are to reflect the structure of the latest version of the Code for the European Federation of Pharmaceutical Industry Associations (EFPIA) and to “simplify, clarify, harmonise and remove repetition” and, more generally, to make it accessible for its intended audiences and be future-proofed, where possible.

As a reminder, amongst the guiding tenets of the ABPI are the following key principles:

“Patients are at the heart of our industry. We aspire to ensure that everything we do will ultimately benefit patients. Our primary contribution to society is to research and develop high quality medicines and to encourage their appropriate and rational use. Patient safety is paramount.

Ethical relationships with stakeholders are critical to our mission of helping patients, guiding the appropriate use of our medicines and ensuring the appropriate and timely exchange of scientific information”.

The new code contains a thematic colour-coded approach to the required standards relevant to particular stakeholders:

  • Overarching Requirements – Grey
  • Promotion to Health Professionals – Blue
  • Interactions with Health Professionals and Healthcare Organisations – Green
  • Interactions with Health Professionals and Healthcare Organisations, Patient Organisations, the Public and Journalists – Yellow
  • Specific Requirements for Interactions with the Public, including Patients, Journalists and Patient Organisations – Pink
  • Annual Disclosure Requirements – Teal

Some of the key changes include:

Clause 2

Clause 2 of the 2019 version states that “Activities or materials associated with promotion must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry”.

Clause 2 of the 2021 version removes the words “associated with promotion” so that it now reads:

“Activities or materials must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry”. This important overarching obligation therefore applies across the board to all activities of pharmaceutical companies.

Clause 20

Clause 20 of the 2021 Code introduces the concept of “collaborative working”. This covers “working with other parties to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the NHS and as a minimum, maintain patient care”.  This definition goes further than “joint working” under the 2019 code which covered only activities involving direct benefit to patients.

Contracted Services

This term replaces “use of consultants”. There is also an additional requirement from 2022 to disclose payments for contracted services paid to members of the public not representing patient organisations.

Donations and Grants

The term “Medical and Educational Goods and Services” from the 2019 version is no longer to be used, but these goods and services will now be covered by donations and grants. “Donations” will cover physical items and services whereas “Grants” now just covers the provision of funds.

Digital Communications

The new code expressly refers to digital communications throughout.

Covid 19 Amendments

A number of amendments have been made, including to Clause 26, Relations with the Public, to reflect the impact of the coronavirus. These include the temporary supply of medicines for public health emergencies; promotions of such medicines to health professionals can only be made with the consent of health ministers. Finally, the usual prohibition of advertising prescription-only medicines to members of the public does not apply to vaccination campaigns carried out by pharmaceutical companies and approved by health ministers. For full details click here.

For those readers who are very familiar with the 2019 Code, changes from the 2019 version are shown in the tracked changes version shown here.

Following publication of the agreed Code for 2021 the PMCPA is consulting on two further amendments that it wishes to make before the Code takes effect on 1 July 2021. Once these proposed amendments have been considered and published by the PMCPA, Prospect Law will publish a short summary.

About the Author

David McIntosh was admitted as a Solicitor in 1988 and is a highly experienced commercial projects lawyer who has advised clients in a number of different fields including intellectual property, data privacy, procurement law (both public and private), manufacturing, distribution, information governance and general regulatory matters covering both the nuclear and pharmaceutical sectors.

Prospect Law is a multi-disciplinary practice with specialist expertise in the energy, infrastructure and natural resources sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and other technical experts.

This article remains the copyright property of Prospect Law Ltd and Prospect Advisory Ltd and neither the article nor any part of it may be published or copied without the prior written permission of the directors of Prospect Law and Prospect Advisory.

This article is not intended to constitute legal or other professional advice and it should not be relied on in any way.

For more information or advice on your company’s promotional arrangements to healthcare professionals, or any issue arising from the 2021 Code, please contact David McIntosh on dmc@prospectlaw.co.uk or +44 (0) 7483 300 132.