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:
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.
The judgment was handed down pretty much on the tenth anniversary of the original dawn raids in November 2008. The raids came as a follow-up from the European Commission’s pharma sector enquiry and led to a number of infringement decisions that have also found their way up to the General Court and to the Court of Justice of the EU. The key theory which the EU Commission advanced in the cohort of these so-called ‘pay-for-delay’ cases is, very broadly, that EU competition law can intervene in patent settlement cases in certain circumstances (both under the rules on abuse of dominance and restrictive agreements). These circumstances are (again, very broadly) where (i) the settlement proposal restricts entry by an actual or potential generic competitor—the delay element, and (ii) where the originator company makes a value transfer to the potential generic entrant – the payment element. This could be by way of a lump-sum payment or through some other way (e.g., through a beneficial distribution agreement). On abuse of dominance, the theory is that unilateral conduct aimed at “shutting out a competing technology and buying out a number of competitors” constitutes an abuse. These theories are now being tested in the European Courts.
In parallel, the UK’s Competition and Markets Authority (CMA)—or OFT, as it then was—investigated similar issues in Paroxetine, a case which the European Commission pushed to the CMA because of an EU limitation issue and which the CMA pursued as the UK does not have a limitation period for competition law infringements. That case is currently under appeal before the Competition Appeal Tribunal which in turn has referred a number of questions to the European Court of Justice.
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.
- Overview of the EU pharmaceutical law framework
- Clinical trials, unlicensed supply and compassionate use
- Obtaining marketing authorisations
- Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
- Advertising and promotion of medicinal products
- Pricing and reimbursement in the UK
- Supply chains
Who is it relevant for?
The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 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.
On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit.
What is exhaustion?
As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from using that right to stop the importation of a product into an EU country where it has been lawfully placed on the market in another country in the European Economic Area (EEA). In other words, an IP holder cannot use its IP rights to prevent parallel import (sometimes called grey imports) of goods from within the EEA. Unless the law is changed, this will not apply after Brexit, because the UK will no longer be part of the EEA. The proposed legislation seeks to change this so that exhaustion still applies to any goods brought into the UK, provided they have been placed on an EEA market with the IP owner’s consent. This will apply irrespective of whether there is a Brexit deal or not, and it is intended that this comes into effect on Brexit-day, if approved by Parliament.
On 5 December 2018, the High Court rejected Concordia’s application to obtain full access to the information underpinning the Competition and Markets Authority’s (CMA) application for a warrant for a dawn raid, over which the CMA had claimed public interest immunity (PII). The judge did, however, allow Concordia access to some information.
The case arose from the reimbursement by the Italian authorities of medicinal products used for an indication for which they are not authorised, in circumstances where there is an alternative authorised product available. Italian law permits the reimbursement of such products “provided that the [unlicensed] indication is known and is in line with research conducted by the national and international medical-scientific community on the basis of economic and suitability considerations”. In these cases the Italian Medicines Agency (AIFA) puts in place monitoring arrangements intended to protect patient safety.
Avastin® (bevacizumab), which is licensed for administration by intravenous infusion for various oncology indications, was added to the Italian reimbursement list in 2014, for intravitreal injection in the eye for the treatment of ophthalmology conditions, on the following conditions:
- To ensure sterility, packaging of bevacizumab in single dose syringes must be carried out solely by hospital pharmacies satisfying defined requirements and following rules to ensure the doses are properly prepared.
- The product can be administered only by highly specialised ophthalmological departments in designated public hospitals.
- Administration may take place only once the patient has signed an informed consent, including the scientific reasons, accompanied by adequate information about the existence of approved alternative therapies at higher cost to the Italian health service.
- A monitoring record must be created with an adverse reactions declaration form.
Novartis Farma challenged the inclusion of Avastin® in the reimbursement list on the basis that this was incompatible with EU pharmaceutical law. In particular: (i) the general use of medicinal products “off-label”, for financial reasons, in circumstances where the suitability of the licensed product for such use has not been tested, breaches the mandatory character of a marketing authorisation (MA) under Art 6 of Directive 2001/83/EC and is incompatible with Directive 89/105/EEC (the Transparency Directive); (ii) by allowing AIFA to establish monitoring mechanisms to safeguard patient safety, Italian law permits AIFA to encroach on the role of the EMA as established by Regulation No 726/2004; and, (iii) the repackaging of Avastin® does not comply with the conditions required for the exemption under Art 3.1 of Directive 2001/83/EC to apply.
The Italian Court referred four questions to the CJEU.
On 12 November 2018 the EU Commission announced that its rapid alert system formerly known as ‘RAPEX’ is being updated and rebranded as ‘Safety Gate’. Aside from the rebranding, the main new features of the Safety Gate platform are that it is more accessible to consumers, being now available in 25 languages, and it is capable of being shared by consumers via social media.
With certain exceptions, this online product safety database covers dangerous non-food products. It includes cosmetic products, but not medicines or medical devices. It is populated by alerts of potentially serious risks posed by such products. In line with applicable EU legislation, economic operators are required to notify risks presented by products that they have placed on the market in the EU to the competent national authorities in the Member States in which the affected products have been sold. The legislation requiring such notification is the General Product Safety Directive, or sector-specific legislation with similar effect, such as the legislation applicable to toys and electrical goods, as implemented in each Member State. The legislation also obliges operators to take corrective actions, such as product recall, if appropriate.
The UK Government (Department of Health and Social Care, DHSC) and the ABPI have announced today that they have agreed the Heads of Agreement for what will now be called a Voluntary Scheme for Branded Medicines Pricing and Access, expected to become effective from 1st January 2019 following the end of the current 2014 Pharmaceutical Pricing Regulation Scheme (PPRS”).
The details of the new Voluntary Scheme are still being finalised and, if agreed in full, will be published in December, at around the same time as publication of the new Statutory Scheme is expected to take place. Companies will then be asked to decide whether to agree to participate in the Voluntary Scheme or be subject to the Statutory Scheme.
The new Voluntary Scheme, which has been described as “a good deal for patients, the NHS and the UK life science industry” by the Health Secretary, Matt Hancock, provides a guarantee that growth of the NHS branded medicines bill will not exceed 2% per year for the next 5 years, delivering expected savings of around £930 million to the NHS in 2019. In assessing growth sales by Voluntary Scheme members, Statutory Scheme companies and parallel import sales will be taken into account. As under the 2014 PPRS, the new Scheme will require industry to make rebate payments in respect of expenditure by the NHS that exceeds the permitted growth. Other important aspects are said to be:
On 14 November, the Supreme Court handed down its judgment on the validity and infringement of the second medical use patent that protected Pfizer’s Lyrica® (pregabalin) for the treatment of various types of pain. In Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor  UKSC 56, the Court decided that the patent held by Warner-Lambert (a company in the Pfizer group) was invalid for insufficiency, because it did not render it plausible that pregabalin would be effective to treat all of the claimed types of pain. The Court also held that, had the claims been valid, they would not have been infringed by a “skinny label” generic version of pregabalin that had the protected indications carved out. However, the five judges of the Court were not in agreement on several key points.