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

On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012,  was laid before Parliament.  These regulations will come into force on 9 February 2019.

The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products, and the associated Commission Delegated Regulation 2016/161/EU (the Delegated Regulation), which sets out the details of these features. However, the Amending Regulations have also introduced an important new provision allowing for “serious shortage protocols” (SSPs) to be put in place for prescription-only medicines (POMs) in certain circumstances, and have extended the types of product containing naloxone (indicated for the treatment of opioid overdose) that drug treatment services may supply in an emergency.

Continue Reading Amendments to UK Human Medicines Regulations 2012

Earlier this week, the Commission published a new Regulation amending Regulation 726/2004 that governs the centralised procedure and that sets out the rules for the EMA: Regulation 2019/5. Many of the changes move and consolidate the provisions set out in other Regulations into Regulation 726/2004 on the centralised procedure (known as the Regulation on the Centralised Procedure). We are preparing a more detailed advisory of the implications of the new Regulation, but some headline points are as follows:

Continue Reading New EU Regulation amending rules on centralised procedure

As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a “hard Brexit”.

Following publication of the technical notice in August 2018, which we considered in an earlier blog, a consultation was launched in order to seek views on the mechanics behind some of the proposals. The consultation ended on 1 November 2018; the responses were reviewed and the technical notice updated. However, the notice states in a number of places that further guidance will be published in due course.

Continue Reading MHRA’s updated guidance on a hard-Brexit