On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.

DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but supplied and obtained separately.

Continue Reading EMA releases draft guidelines on drug-device combinations

Arnold & Porter’s Future Pharma Forum invites you to a complimentary competition/antitrust seminar aimed at junior lawyers and professionals new to the UK/EU life sciences industry. This seminar will provide a refresher of key EU and UK competition law topics, cover some key issues from an in-house practitioner’s perspective and touch on the implications of Brexit.

» Register to Attend

Topics

  • Competition law refresher
  • Spotting and avoiding competition law problems when drafting contracts
  • Pricing issues in the pharmaceutical sector
  • The impact of Brexit

Date and Time

Thursday, 13 June 2019

  • 5:15 PM Registration
  • 5:30 PM Seminar
  • 6:30 PM Networking Drinks & Canapés

Location

Arnold & Porter, Tower 42, 25 Old Broad Street, London, EC2N 1HQ (View Directions)

About the Forum

The Arnold & Porter Future Pharma Forum provides training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct experience-appropriate seminars and events aimed at junior and mid-level lawyers up to around eight (8) years PQE. There are no formal entry or membership requirements—please feel free to pass this to colleagues who might be interested in attending.

Apologies that it has been a while since we’ve posted! We have lots in the pipeline, starting with this webinar.

Data and Its Impact on Medical Technology Companies Doing Business in the EU

Today’s medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is a growing need for fully integrated data generation, collection and analysis as part of the development and marketing of medical technology. As a result, companies seeking to launch new technologies in the EU or expand the labelling of their EU-marketed products need to consider the regulatory and economic burden of complying with new, heightened data submission requirements.

Topics

This webinar is designed to provide guidance on the following issues:

  • Identifying the clinical data needed to comply with European Medical Devices Regulations as compared to FDA requirements.
  • Generating post-marketing data to support the clinical and economic value proposition for medical technologies.
  • Addressing data security and privacy concerns, with a focus on digital health.

More information in available here, and you can sign up here.

Hope to see you there!

On 28 January 2019, the European Commission (Commission) published its Report to the Council and the European Parliament on Competition Enforcement in the pharmaceutical Sector (2009-2017) (Report). This takes stock of all the pharma cases that the Commission has pursued at EU level and that national competition authorities have investigated over the past 10 years.  It responds to recent concerns raised by the Council and European Parliament that anti-competitive practices of pharmaceutical companies may prevent patients’ access to affordable and innovative medicines.

In parallel, the UK Competition and Markets Authority (CMA) has been very active in investigating the pharma sector and currently has some eight ongoing investigations. Some of these investigations are being narrowed but the overall mood music is that authorities regard pharma cases a high priority. This trend is likely to continue for some time yet.

The key takeaways are (i) pharma cases are likely to continue to be of interest to competition authorities (ii) entry restrictions, high price strategies and loss of exclusivity are key areas of concern together with, going forward, the entry of biosimilar competition.

Continue Reading European Competition enforcement in the pharmaceutical sector: more to be expected?

The UK Government published today details of the temporary tariff regime that will apply from 11pm on 29 March 2019 if the UK leaves the European Union (EU) without a deal (see here). This is being published ahead of the vote in Parliament on no deal to ensure that the members of parliament are well informed.

The new regime is temporary, and the government intends to closely monitor the effects of these trade tariffs on the UK economy. It would apply for up to 12 months while a full consultation and review on a permanent approach to tariffs are undertaken.
Continue Reading Impact of UK’s Temporary Tariff Regime on Life Sciences

On 23 January 2019, the European Data Protection Board (EDPB) adopted an Opinion on the interplay between the Clinical Trials Regulation (CTR), which is likely to become applicable in 2020 (if not later), and the European General Data Protection Regulation (GDPR). The Opinion focusses on an area provoking much discussion since the GDPR came into force; that is, as we discussed in our previous blog, which legal bases under the GDPR are appropriate for processing personal data in the context of clinical trials?

Continue Reading GDPR and clinical trials—more clarity?

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?

On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In practice, this prevents the competent authorities from publishing a complete SmPC, showing all indications associated with the innovator product, on their website.

Today’s judgment will be welcomed by innovative companies seeking to ensure the effectiveness of their second medical use patents.

Continue Reading CJEU decision on scope of skinny labels

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

As we approach one year to go before the application of Regulations (EU) 745/2017 (Medical Devices) and 746/2017 (In Vitro Diagnostic Medical Devices) (applicable in May 2020 and May 2022, respectively), the European Commission has updated its website to collate all of its guidance on the legislation. This includes a recently published series of nine non-binding practical reference guides, which is now available in a new section of the website entitled “Spread the word” – part of the Commission’s campaign to “inform as many stakeholders as possible about their roles and responsibilities under the new Regulations“. In particular, they consist of:
Continue Reading New guidance on the European Medical Devices and In Vitro Diagnostic Medical Devices Regulations