UK sets deadline for novel food authorisation of CBD products

By Thomas McGuire, Katharina Ewert and Brian Kelly on February 14, 2020 Posted in Brexit, Food & Beverage, Food & Drug Regulatory

The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications. After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other novel CBD products will be removed from sale. In online guidance for businesses the FSA strongly recommend that applications are sent to the FSA for consideration – as well as to the European Commission as usual – so that they may progress swiftly through the UK authorisation process from 1 January 2021, at the end of the UK’s Brexit transition period.

The move follows an update in January 2019 to the EU Novel Foods catalogue, which classified CBD as a novel food on the basis that there was inadequate evidence of its use as a food before 15 May 1997. The catalogue is non-binding but in practice is followed by EU Member States. Indeed, recently, courts in Germany have held that the catalogue is indicative and can be relied upon, as it reflects the current views of the European Commission and the competent authorities in the Member States.

The UK’s 31 March 2021 deadline only applies to novel CBD products that are already on the market and does not include products that are not yet on the market, meaning that no new CBD products will be allowed on the market without the appropriate authorisation, according to the FSA. Accordingly, the FSA has advised local authorities that businesses may continue to sell existing CBD products until the deadline (provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under drugs legislation), but no new CBD products should be sold until they have been authorised.

The FSA is responsible for regulating CBD as a novel food and the authorisation regime outlined above will apply to CBD products sold as food or as food supplements, including: oils, drops or tinctures, gel capsules, sweets and confectionery, bread and other bakery products and drinks. The FSA is not responsible for products such as cosmetics, vapes, medicinal CBD products or products containing controlled drugs such as THC, which fall under different regimes, including rules governing medicines and controlled substances.

The FSA has also issued precautionary consumer advice on the consumption of CBD. This follows the Committee of Toxicity (COT) considering the available scientific data on the safety of CBD and publishing an update outlining their findings. The FSA has followed the COT’s recommendations and advises that vulnerable groups (those who are pregnant, breastfeeding or taking medication) should not consume CBD at all, and healthy adults should limit their consumption to no more than 70 mg of CBD a day, unless advised otherwise by a doctor. Businesses selling CBD products are expected to be aware of this advice and should “be able to inform consumers” of the recommended daily dose for healthy adults, and of the potential risks to those in vulnerable groups.

The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim

By Brian Kelly, Lukasz Gorywoda and Katharina Ewert on February 10, 2020 Posted in Food & Beverage, Food & Drug Regulatory

Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists.

In Case C-524/18, Dr. Willmar Schwabe v. Queisser Pharma, the German Bundesgerichtshof asked the Court of Justice of the European Union (“CJEU”) to clarify if a general, non-specific claim included on the front of the outer packaging was “accompanied” by a specific health claim within the meaning of Article 10(3) of the NHC Regulation, if the non-specific claim was included on the front of the packaging and the specific health claim on the back, without an apparent link between the two.

In his Opinion, Advocate General Hogan had suggested a three step approach to interpreting Article 10(3) of the NHC Regulation: (1) the specific health claim has to be authorised, (2) the specific health claim must support the general health claim and (3) the relationship between the two claims must be determined by reference to the “average consumer who is reasonably well informed, and reasonably observant and circumspect.” He concluded, that the national Court had to consider whether the relationship between the two claims was sufficiently clear to an average consumer. In his view, it would be “sufficient that the specific health claims are given sufficient prominence such that they are accessible and can be read by the consumer”, without the need for the two claims to be placed “next to, or follow or otherwise immediately adjacent” to each other, nor did the law require an asterisk.

The CJEU handed down its judgment on 30 January 2020. The judgment takes a slightly different approach than the Advocate General Opinion in the way in which it sets out the test for the meaning of “accompanied” under Article 10(3) of the NHC Regulation. Specifically, the Court considered that the word had to be interpreted taking into account both a “substantive and a visual dimension” and that it was for the national court to determine whether the product in question met the test.

As for the “substantive dimension”, the CJEU noted that the general and the specific health claim had to “match, implying, in substance, that the former fully supported the latter.” However, such a clear link between the claims’ content, irrespective of their location on the packaging, was insufficient in itself. Rather, the CJEU noted that both claims had to be located on the packaging in such a way to enable an average consumer to understand the link between the two (the “visual dimension”). According to the CJEU, a direct visual link between the general and the specific health claim requires, in principle, “spatial proximity” or “immediate vicinity” between those claims, so that the average consumer can immediately recognize the link between the two claims. In its reasoning, the CJEU also cites the European Commission Guidelines on Article 10 of NHC Regulation (Implementing Decision 2013/63) to demonstrate that the visual dimension has some role to play in the interpretation of the meaning of “accompanied.”

However, the CJEU also noted that “exceptionally”, it may be possible for a general, non-specific and the “accompanying” specific health claim not to appear on the same side of the packaging, provided that an “explicit reference, such as an asterisk” allows the consumer to make the connection between the two claims.

While the main focus of the case was on the interpretation of the word “accompany” for the purposes of Article 10(3) of the NHC Regulation, the CJEU also clarified in the same case that any general, non-specific claims had to be substantiated in accordance with the requirements of the NHC Regulation. However, it was sufficient to that end, if the non-specific claim was “accompanied” by a specific health claim.

NHS England Publishes Draft Commercial Framework for Medicines

By Raj Gathani, Grant Castle and Brian Kelly on November 14, 2019 Posted in Food & Drug Regulatory, Healthcare system, Medicinal Products, Pharmaceutical companies

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later in 2020.

The Commercial Framework describes how NHS England, the National Institute for Health and Care Excellence (“NICE”) and pharmaceutical companies could work together to support the introduction of clinically and cost-effective branded medicines into the NHS, by striking commercial deals.

Developing and publishing the Commercial Framework makes good a commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (“Voluntary Scheme”). The Voluntary Scheme is one of two price control schemes operational in the UK, which restrict prices that the NHS pays for many branded medicines. The 2019 Voluntary Scheme refreshed and replaced the former Pharmaceutical Price Regulation Scheme (“PPRS”). One of the key themes of the new scheme was to add more flexibility to market-access, including in some cases by finding commercially negotiated ways forward.

The draft Commercial Framework makes clear its intention to support NICE’s health technology appraisal process (by which NICE issues a recommendation on a product’s use within the NHS), rather than act as an alternative or substitute to it. In that context, the draft sets out various commercial options available to companies through the market-access process. Some of these options are already well-established parts of the NICE’s assessment framework, including (for example):

Simple or Complex Patient Access Schemes – by which a reimbursement recommendation from NICE is contingent on a company offering a confidential percentage discount to the NHS or more complex, non-confidential value propositions; and
Managed Access Agreements – which are, in essence, commercial deals for a fixed period that allow time to resolve clinical or cost-related uncertainties at the time of a NICE appraisal.

Importantly, the draft Commercial Framework also proposes when and how NHS England might agree to so-called “Confidential Commercial Agreements.” NHS England might consider these agreements in the following circumstances:

When a company intends to put an “enhanced value” offer to the NHS. In essence, this allows a company to put together a complex and confidential commercial deal, with the emphasis on delivering cost-effectiveness under NICE’s standard assessment methods.
When “unusual or unique circumstances” surrounding a NICE appraisal make launch a particular product challenging or commercially unviable to the company developing it. In those circumstances, NHS England has the ability – on a case-by-case basis — to reach a bespoke solution with the company concerned. The draft proposal states that NHS England would have this level of commercial flexibility only when the product offers a significant health gain and when the company would otherwise lose significant revenue that it could not recover in later years. This could be an important development for high-cost; high-benefit products resulting from expensive, pioneering innovation.

Separately, the draft Commercial Framework sets out how NICE and NHS England aim to engage with pharmaceutical companies at an early stage to discuss market access and give preliminary direction to the process.

The draft document also makes clear that the Commercial Framework is designed to be a living document. Eventually, the aim is to broaden its scope to cover biosimilar and generic products, in addition to branded medicines.

European Commission publishes Strategic Forum’s recommendations on Smart Health

By Kristof Van Quathem and Anna Oberschelp de Meneses on November 7, 2019 Posted in HEALTH PRIVACY, Privacy & Data Security

On November 5, 2019, the European Commission published a report entitled “Strengthening Strategic Value Chains for a future-ready EU Industry”, which was prepared by the Strategic Forum on Important Projects of Common European Interest (“Forum”). The Forum assists the European Commission in identifying key strategic value chains that can contribute to Europe’s industrial competitiveness and its green and digital transformation objectives. To that end, the Forum proposes a common vision for joint actions and investments between the EU, its Member States, and industry.

The report identifies smart health as one of the key strategic value chains. Other key strategic value chains include the industrial Internet of Things and cybersecurity.

The Forum defines “smart health” as “the development of smart (usually digitally aided) solutions to improve the way healthcare solutions are delivered”, and highlights the importance of health data and health analytics to improve healthcare in the EU. However, according to the report, a number of challenges at the EU-level appear to hamper the development of smart health solutions. These challenges include “the high costs associated with the installation of systems using advanced technologies, as well as concerns over data security, and a lack of integration and information sharing”. The Forum concludes in its report that there is a need for public intervention to overcome these challenges. In particular, the Forum refers to the need to (i) increase public funding in this area; (ii) regulate and harmonize—at the EU-level—access to and use of health data, and (iii) create trust by citizens through data governance and consent management models.

In light of the above, the Forum’s report provides the following six recommendations:

create a federated European health data space with appropriate privacy protections;
support the development of smart health products and services;
adapt regulations and standards with the aim of “advancing standardization and interoperability of healthcare data”;
promote skills for the development, uptake and effective use of smart health products and services;
stimulate the demand-side and the uptake of smart health products and services; and
create a pan-European operational network (a “European Smart Health Innovation Hub”) to assess and promote smart health initiatives.

The report sets out specific actions for each of these recommendations.

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

By Brian Kelly and Katharina Ewert on September 12, 2019 Posted in Food & Drug Regulatory, Medicinal Products, Pharmaceutical companies

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that a clinical study report it submitted to the EMA in support of marketing authorisation for its ultra-orphan drug Translarna was presumptively confidential and should not be disclosed to a competitor. However, this position was dismissed by the General Court of the EU in early 2018.

On appeal to the Court of Justice, however, PTC argued that the General Court had erred in arriving at that decision, raising a number of grounds, including that on a proper interpretation of the relationship between the Regulation No 726/2004 and Regulation No 1049/2001, the report at issue is covered in its entirety by a general presumption of confidentiality. In his opinion, AG Hogan disagreed with the General Court’s assessment of the relevant legislation, noting in particular that Article 39(3) of the TRIPs Agreement provides that data must be protected against disclosure unless steps are taken to ensure that such data are protected against unfair commercial use. On this point, the General Court stated in paragraph 91 of the judgment under appeal that ‘potential misuse of the report at issue by a competitor is not in itself a ground for considering that information is commercially confidential under Regulation No 1049/2001’. AG Hogan explained that while this statement is correct so far as it goes when it comes to considering the ‘commercial confidentiality’ exception in the first indent of Article 4(2) of Regulation No 1049/2001, it did not ensure that release of undisclosed data would not undermine the data and marketing exclusivity of the originator company, particularly in countries outside the EU.

As such, AG Hogan considered that the General Court had erred in law in so far as it concluded that there was no general presumption that CSRs should not be disclosed by reference to the first indent Article 4(2) of Regulation No 1049/2001. AG Hogan also considered that the General Court had erred in law in so far as it concluded that the disclosure of the report at issue would not compromise the appellant’s commercial interests for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001. The AG added, however, that the EMA does not need to rely on the presumption of confidentiality. In practice, though, this would likely make a finding by the EMA that certain data are not commercially confidential more difficult in cases of detailed and individualised assessment of clinical study reports. The AG opinion is non-binding and it will now be for the Court of Justice to assess the case in light of this opinion.

The opinion can be accessed here.

Another appeal brought by a veterinary pharmaceutical company in relation to pre-clinical study reports was heard in parallel and AG Hogan reached the same conclusion. That case can be accessed here.

Covington acted for the appellants in both cases. If you have any questions concerning the material discussed in this blog post, please contact the following members of our life sciences team: Brian Kelly, Grant Castle, Sarah Cowlishaw or Katharina Ewert.

Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

By Grant Castle on August 22, 2019 Posted in European Union, Food & Drug Regulatory, Medical Devices, Medicinal Products, Pharmaceutical companies

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them. This includes a general prohibition against offering such benefits.

To strengthen the existing regulatory framework, France has taken several additional actions and significantly amended the anti-gift provisions, by an Ordinance dated 19 January 2017 (“2017 Ordinance”). The new provisions, Articles L1453-3 and following of the French Public Health Code (Code de la Santé Publique or “CSP”), entered into force on 1 July 2018. However, companies affected remain in a grey zone until the publication of implementing texts, that should be available in autumn 2019.

Law No 2019-774 sets out new rules, in particular, on training, hospital locations, video health consultations, and plans for the creation of a new data platform which will collect, organise and make available national healthcare data. Among the new provisions, Law No 2019-774 further elaborated the anti-gift provisions of the Public Health Code.

First, Law No 2019-774 ratifies the 2017 Ordinance, so that text becomes law. Ratification was needed to maintain the validity of the 2017 Ordinance for the future.

Second, article 77 of the law provide some changes to the anti-gift rules.

Article L1453-5 of the Public Health Code has been modified to clarify the scope of the anti-gift rules. Under the 2017 Ordinance, the scope of the rules has been broadened and all pharmaceutical companies are now subject to the anti-gift rules regardless whether or not they have products on the market in France. In addition, the law brings within the scope of the anti-gift rules products that are covered by the national health insurance system (‘social security’) even if the ANSM (the French authority for health products) does not regulate them. Examples include clinical nutrition products.

As an exception to the general prohibition on the offer of benefits to HCPs, it is possible to offer benefits of negligible value. The amount of these benefits of negligible value by category of benefit (i.e., meals included in normal working relationships, books, office supplies, items of medical utility, etc.) will be defined in an implementing text that should be published in the coming months. In addition, Law No 2019-774 specifies that the maximum amount per benefit must be defined over a specified period of time (Article L1453-6, 4°).

Law No 2019-774 also expressly prevents professional ethics boards (conseils nationaux professionnels) from receiving any donations or grants in cash or in kind (Article L1453-7, 3°).

Finally, hospitality during scientific or professional meetings or promotional events cannot be offered to healthcare students and student associations anymore, in order to minimize or even eliminate any pressure on students and put an end to influential practices that are quite common in training places such as universities or health institutions (Article L1453-7, 4°).

Moreover, article 78 of the law also introduces a new definition under the sunshine rules. Influencers are now expressly covered by the transparency requirements. Article L1453-1, 7° states that companies marketing relevant products shall make available on a public website the existence of any agreement, and any benefits and fees granted to “persons who, in the media or on social networks, present one or more health products in such a way as to influence the public.”

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

By Harriet Fletcher and Sarah Cowlishaw on August 9, 2019 Posted in Food & Drug Regulatory, Medical Devices, Privacy & Data Security

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator in Europe that apply cybersecurity considerations specifically to medical devices. The full ANSM draft guidelines, ‘Cybersécurité des dispositifs médicaux intégrant du logiciel au cours de leur cycle de vie’ (‘Cybersecurity of medical devices integrating software during their life cycle’) published 19 July 2019, is available in French here, and in English here.

The draft guidelines note that while the European regulatory framework (the Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017 /746) has been modified “in line with technological developments” (e.g. “data exchange, monitoring, risk prediction and control software”) to include software within the definition of a medical device, and accompanying security and performance requirements specific to such medical devices incorporating software, the “[medical device and in vitro diagnostic medical device r]egulations do not explicitly refer to or elaborate on the notion of cybersecurity”. For the purposes of the guidelines, ‘cybersecurity’ is described as “the full set of technical or organisational measures set up to ensure the integrity and availability of a [medical device] and the confidentiality of the information held on or output by this [medical device] against the risk of targeted attacks.” Continue Reading

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

By Katharina Ewert and Harriet Fletcher on March 7, 2019 Posted in Brexit, European Union, Food & Drug Regulatory, Medical Devices

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).

Legislative Background

The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

By Grant Castle and Katharina Ewert on February 26, 2019 Posted in Brexit, European Union, Food & Drug Regulatory, Medicinal Products, Pharmaceutical companies

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here). The letter seeks to address concerns that a number of pharmaceutical companies will not have been able to adjust their pharmaceutical supply chains to provide for quality control testing and batch release of product in the EU-27 and to reflect these changes in relevant marketing authorizations in time for a no-deal Brexit if that occurs on 29 March 2019. The Commission gives EU-27 (or EEA-30) regulators scope to accept the results of quality control and batch release testing in the UK, provided that marketing authorization holders (“MAHs”) submit valid requests for an exemption before 29 March 2019.

The UK will become a third country vis-à-vis the EU-27 at midnight CET on 29 March 2019, unless the parties agree an extension under Article 50 of the Treaty on European Union or a transitional period, e.g., by ratifying the Withdrawal Agreement.

This means that the rules for imports from third countries will apply to medicines entering the EU-27 from the UK. Specifically, Directives 2001/82/EC and 2001/83/EC require that: (a) medicinal products imported from third countries undergo quality control testing in the EU/EEA; and (b) the qualified person within an appropriately authorized batch release site within the EU/EEA batch releases the product onto the EEA market.

The Commission’s letter allows competent authorities to permit MAHs, manufacturers and importers of medicinal products coming from third countries “in justifiable cases” to have third parties carry out certain controls (Article 20(b) of Directive 2001/83/EC and Article 24(b) of Directive 2001/82/EC). With this in mind, competent authorities may grant MAHs an exemption allowing them to rely on UK quality control testing for a limited period after Brexit. The exemption is subject to the following conditions:

A batch release site in the EU27 is identified by the marketing authorisation holder by the withdrawal date.
The batch release site is supervised by a qualified person established in the EU27 by the withdrawal date.
The establishment designated by the third party conducting the quality control testing may be verified by a competent authority of the EU27, including on the spot checks.
All necessary steps have been taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27.

MAHs must notify their intention to rely on the exemption immediately and in any event before 29 March 2019 either to their national competent authority or to the EMA for centrally authorized products:

“In the notification the marketing authorisation holder must:

specify the batch release site in the EU27.
confirm that the qualified person established in the EU27 is responsible for the quality control testing site in the United Kingdom.
confirm and set out their precise timetable for transfer of the quality control testing site (which should allow the process to be completed quickly and in principle by the end of 2019 at the latest).
specify the period of time and batches (packs and quantities) that are requested to be exempted. This should be strictly restricted to what is necessary.
commit to providing batch testing results for those batches from the existing facilities within the United Kingdom.
transfer samples of those tested batches together with the testing results to the batch release site in the EU27 in due time to make them available for inspection.”

Under this special procedure, which falls outside the scope of the Variations Regulation (EC) No. 1234/2008, the EMA or national competent authority will assess the notification and if justified, grant the exemption “for the time period strictly necessary and for the specific batches identified.” The relevant authority will notify the MAH about the grant of the exemption in writing. The MAH shall provide a copy of the confirmation to the competent authority responsible for the batch release site. The effect of the exemption is that the qualified person may batch release UK-control tested products for the EU-27 (or EEA-30) market.

In the absence of an exemption, products entering the EEA-30 from the UK must undergo both control testing and batch release in the EU/EEA before they can be placed on the those markets. In this context, the Commission also reminds MAHs of their obligation to notify any anticipated disruption of supply two months in advance. This means, if companies anticipate Brexit-related supply issues, they should notify the relevant competent authorities now.

This exemption would not apply if the EU-27 and the UK are able to ratify the Withdrawal Agreement. The terms of that Agreement provide for a transitional period until the end of 2020, during which the medicines regime will continue to apply to and in the UK. Thus, MAHs could continue to rely on UK quality control testing during such a period.