Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.


Continue Reading Medical Devices and Compulsory Insurance in the EU

The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.

Continue Reading UK government publishes new draft legislation on medicines and medical devices

Yesterday, the Food Standards Agency (FSA), which regulates foods and food businesses in England, Wales and Northern Ireland, issued its long-awaited statement on CBD in foods.

In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods, as a history of consumption has not been demonstrated. As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as novel. The FSA responded by stating that it accepted the conclusion of the Commission and was “committed to finding a proportionate way forward…to clarify how to achieve compliance in the marketplace in a proportionate manner”.

Following the UK’s departure from the European Union, the current rules on novel foods will continue to apply until 1 January 2021, when the transition period under the UK’s withdrawal agreement from the EU comes to an end. However, the FSA has now confirmed its position on enforcement and prescribed actions which it considers “are a pragmatic and proportionate step in balancing the protection of public health with consumer choice“.


Continue Reading Food Standards Agency announcement on CBD

On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (the “Regulation”) was published in the Official Journal of the European Union.

Review of the matters addressed by the Regulation was initially prompted by a European Citizens’ Initiative (#StopGlyphosate), which campaigns against the use of toxic pesticides and for reform of the EU pesticides approval procedure.

The new Regulation principally amends Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (the “General Food Law Regulation”). It also amends eight sector-specific legislative acts, concerning genetically modified organisms, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.


Continue Reading Strengthened Transparency in the EU General Food Law Regulation

On 15 April we issued a client Advisory summarising the current regulatory environment in Europe and the US for foods and cosmetics containing cannabidiol (CBD).

The status of such products, however, remains uncertain in several important respects. This note therefore identifies areas where developments or clarification are currently anticipated and addresses the use of CBD in vaping products.


Continue Reading Update on the EU Regulation of CBD in Foods and Vaping

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

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.


Continue Reading Novartis Farma SpA v AIFA

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:


Continue Reading The UK 2019 Voluntary Scheme

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?

Judgment was handed down on 21 May in the DePuy Pinnacle Metal on Metal Hip group litigation: Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB)

312 claimants in the group litigation brought claims against DePuy, alleging that the hip prostheses with which they had been implanted were defective for the purposes of the Consumer Protection Act 1987 (the Act) and the Product Liability Directive 85/374/EC (the Directive). The judgement followed a trial at first instance of a common preliminary issue, namely “whether or not the defendant is liable to the claimant, subject to any development risk defence.” The preliminary issue encompassed questions of causation.


Continue Reading England & Wales High Court Judgment in metal on metal hip group litigation