Ewan Townsend

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The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted, the rules will apply to all companies involved in the packaging life cycle that place packaging and packaging waste in the EU internal market regardless of whether these companies are based in the EU.  While there are various exceptions for manufacturers of medicinal products and medical devices sectors, if adopted, the Proposed Regulation will require life sciences companies to make significant amendments to their current and future product packaging, with resulting cost impacts. We set out the key requirements and takeaways from the Proposed Regulation in our Advisory, and will continue monitoring and reporting on new developments as the legislative process evolves.

We have also prepared this helpful summary for your reference. Continue Reading Proposal for Revision of EU Legislation on Packaging and Packaging Waste

In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders

After a public consultation last July, the EMA published its Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAH) on 23 July 2021. The Paper aims to clarify the responsibilities of the MAH in the GMP guidelines and the applicable legislation. While it is not legally binding, the EMA expects competent authorities to use the Paper as guidance when performing inspections, and so MAHs should familiarise themselves with the document. In this blog we have summarised the key takeaways.
Continue Reading EMA Reflection Paper on Good Manufacturing Practices and Marketing Authorisation Holders

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients

On 20 February 2019, the English High Court delivered its eagerly awaited judgment in Canary Wharf v EMA [2019] EWHC 334 (Ch), rejecting the EMA’s argument that the United Kingdom’s withdrawal from the European Union would amount to a frustrating event allowing it to terminate its lease of premises in London.

What is frustration

Under English law, frustration allows a contract to be set aside on the basis of an unforeseen event which renders the contractual rights and/or obligations radically different to those contemplated by the parties at the time the contract was entered into. A successful claim for frustration allows the claimant to terminate the contract immediately and discharges its future liabilities.

EMA’s argument

The dispute between Canary Wharf and EMA centred around EMA’s £500 million, 25-year lease of commercial premises in Canary Wharf. The lease restricted assignment of the property to a new tenant, and also included onerous subletting provisions.

The EMA argued that its lease would be frustrated by Brexit because remaining in the Canary Wharf premises following the UK’s withdrawal from the European Union would be illegal under Regulation (EU) 2018/1718 (the 2018 Regulation), which required it relocate its headquarters to Amsterdam. Once it had relocated, the EMA would be left paying rent for a property which the 2018 Regulation prohibited it from using, and which it could not assign or sublet under the terms of the lease.Continue Reading Frustrated by Brexit?

The Falsified Medicines Directive 2011/62/EU (FMD) introduced a new requirement for safety features to appear on the packaging of all prescription-only medicinal products: a unique product identifier and an anti-tampering device (ATD). Commission Delegated Regulation (EU) 2016/161 sets out technical detail around the characteristics of the safety features, how authenticity should be verified and by whom.

With the deadline to demonstrate compliance with the Delegated Regulation fast approaching (9 February 2019), we draw your attention to recent revisions to the “Question and Answers” guidance document (Version 13) published by the European Commission in January 2019, which contains amendments to some previous questions and a number of new Q&As. In particular:Continue Reading Revised guidance on implementation of the EU Falsified Medicines Directive

Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU

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Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.

In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.Continue Reading UK guidance for developers of health care software and technologies

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary…

The General Data Protection Regulation (GDPR) entered into force on 25 May 2018 and, in the absence of any transition period, companies are now expected to be in full compliance with the new requirements. However, with key guidance from regulators only recently released or still in progress, and national implementing legislation enacted at the eleventh hour, developing a GDPR-compliant approach to consent in the context of clinical trials remains an ongoing project. This post reviews the guidance available to date.
Continue Reading Clinical trial consents under the EU GDPR: where do we stand?