On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

The Guidance provides information on changes and protocol deviations that may be needed in the conduct of clinical trials during the COVID-19 pandemic.  The Guidance includes a harmonized set of EU-level recommendations to ensure the safety of trial participants while preserving data integrity.  The Guidance also advises how these changes should be notified to national authorities.

As clinical trials in the EU are authorized at the national level, this EU-level Guidance does not overrule guidance issued by national competent authorities, to the extent that there is any.  Sponsors and investigators are advised to consult national guidance for relevant national notification procedures, as there is some divergence across EU Member States.

EU-Level Guidance

The EMA acknowledges that COVID-19 and the public health measures that have been implemented in response to the pandemic can result in challenges for the conduct of clinical trials.  Quarantines, site closures, travel limitations, and supply chain interruptions, for example, may require alternative arrangements that lead to protocol modifications and deviations.

It is expected that sponsors and investigators base any decision to adjust the conduct of a trial on a documented risk assessment and implement measures that prioritize subject safety and data integrity.  The EMA’s recommendations for potential changes include the following:

  • The conversion of physical visits into contact by phone or telemedicine to ensure continuous medical care, identify adverse events and maintain oversight.
  • Critical laboratory testing, imaging or other diagnostic tests to be conducted locally where subjects cannot reach the study site.
  • The possible temporary halt of a trial, suspension of new participant enrollment, extension of a trial, or postponement of a trial or the activation of sites not yet initiated.
  • A change in the distribution of the Investigational Medicinal Product (IMP) to ensure patients receive treatment and avoid unnecessary physical site visits. Generally delivery is expected to be from the investigator site to trial subjects, but direct sponsor to subject shipment may be possible in some Member States where national guidance permits.  Sponsors must consider the practical implications of alternative shipping and storage arrangements for IMPs, including route of administration, stability during transit and storage conditions in a subject’s home.  In the event of an urgent shortage of IMP, sponsors may also consider re-distribution between sites in accordance with GMP Annex 13.
  • Where the Principal Investigator is indisposed for a period to delegate his/her duties temporarily e.g., to sub-investigator.

In relation to communication with authorities, the Guidance states that the relevant competent authorities and ethics committees must be informed in accordance with Directive 2002/20/EC and national laws where:

  • a new event is likely to have a serious effect on the benefit-risk balance of the trial; such a change should be implemented as an urgent safety measure; or
  • a change is likely to affect the safety or well-being of the participants and/or the scientific value of the trial but does not require immediate action; such a change should be submitted as a substantial amendment.

National Guidance

Notwithstanding the EMA’s Guidance, several Member States have issued national guidance on the management of clinical trials during the COVID-19 pandemic.  In some instances, national notification requirements are not harmonized with the EU-level Guidance, leading to some divergence across EU Member States and the UK.

National competent authorities that have adopted guidance, include amongst others:

  • The UK’s MHRA issued updated guidance on Managing clinical trials during Coronavirus (COVID-19) on 25 March 2020. The guidance expressly provides that if a trial has been halted due to issues related to COVID-19, there is normally no need to inform the MHRA; instead, the trial master file should include a note that the trial was halted, giving the reason why.  Only if there is a direct participant safety issue should the MHRA be informed in the “normal way” (e., as an urgent safety measure).  The MHRA also needs to be informed if a trial is halted due to a medicines supply issue.  The guidance clarifies that a substantial amendment is not required for the use of phone calls instead of protocol-directed in-person study visits or where participant monitoring visits need to be reduced.
  • Ireland’s HPRA issued Guidance on the Management of Clinical Trials during COVID-19 (Coronavirus) on 16 March 2020. The guidance has been updated to refer to the EMA Guidance and appears consistent with the EU-level position.  The HPRA requires substantial amendments to be submitted to the Authority marked “COVID-19 relevant” and confirms that urgent safety measures can be used, where appropriate.
  • Denmark’s DKMA issued updated guidance on Extraordinary measures for clinical trials due to COVID-19 on 16 March 2020. The guidance recommends that changes due to COVID-19 should be handled as urgent safety measures.  The guidance also expressly allows a single notification to cover several clinical trials if it concerns non-protocol-specific changes.  Once normal procedures are restored after the pandemic, notifications will need to be submitted individually .
  • Norway’s NoMA updated its guidance on Management of Clinical Trials in relation to COVID-19 on 19 March 2020. The guidance states that NoMA defines all changes that must be made as a result of COVID-19 as urgent safety measures.
  • France’s ANSM has issued guidance on COVID-19 – Ongoing clinical trials (available only in French). This states that if the enrollment of new patients is suspended, this should be notified to the ANSM and the ethics committee for information only, but if treatment itself is suspended, this should be notified to the ANSM and the ethics committee as an urgent safety measure and then followed up with a substantial amendment.
  • The Netherland’s CCMO issued Advice for conducting clinical trials during the coronavirus restrictions (available only in Dutch) on 13 March 2020. This discusses certain changes that should be submitted as urgent safety measures and others that can be treated as protocol deviations and would not need to be reported. The guidance states that if a study is suspended, this must be notified to the ethics committee and competent authority immediately if this impacts patient safety or otherwise within 15 days.

 

The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”).  The purpose of the RMVS Specification is to meet the UK healthcare system’s increased demand for ventilators to support patients suffering with Acute Respiratory Distress Syndrome (“ARDS”) caused by COVID-19.

Summary of the RMVS Specification

MHRA accepts that full compliance with current standards for ventilators (namely ISO 80601-2-12:2020) is unrealistic in the emergency timeframe.  MHRA has weighed patients’ need for immediate access to ventilators against the necessity for compliance with all applicable standards.  The Agency accepts that RMVS will not be CE marked and instead will be subject to approval by the MHRA through the “Exceptional use of non-CE marked medical devices” route.  The “exceptional use” route is primarily aimed at “the treatment of a single named patient”.  This route also allows the MHRA to grant approval to manufacturers to supply non-CE marked devices without prior identification of a named patient or to hold as emergency stock for use at short notice.  The UK’s Medical Devices Regulations 2002 also allow the Secretary of State – presumably acting through the MHRA – to authorise, where appropriate for a specified period, “the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with)….”

Whatever the legal basis, manufacturers of RMVS must demonstrate compliance with essential standards for patient safety.  Once the current COVID-19 emergency has passed, RMVS will no longer be useable in hospitals, unless they have been CE marked in accordance with the EU medical devices regulations.

The RMVS Specification sets out both mandatory and optional requirements. These include, amongst others:

  • It is proposed that RMVS would be for short-term stabilisation for a few hours, but this may be extended up to 1-day use for a patient in extremis as the bare minimum function.
  • The ventilator must have at least one mode of ventilation, but optionally 2 modes of ventilation, which can support patients in critical condition.
  • The user must be able to control the percentage of oxygen in the gas being breathed in by the patient.
  • The ventilator must have infection control.  This means that the ventilator must be cleanable by healthcare workers and all parts coming into contact with patients’ breath must be capable of decontamination or disposable.
  • The ventilator must alarm, for example, in response to gas or electricity supply failure, or if the ventilator is switched off while in mandatory ventilation mode.
  • Displays on the ventilator should allow healthcare workers to monitor certain activity.
  • The ventilator must be useable by qualified healthcare professionals, for example, doctors with some experience of ventilator use should not need more than 30 minutes training.
  • Manufacturers must test the ventilator at prototype and final production stage. This should be done as a short Formative Usability Test to ISO 62366 in a realistic environment, where possible.
  • Manufacturers must produce the ventilators from materials and parts readily available in the UK supply chain.  This requirement anticipates an increase in international restrictions on freight movement.

Outstanding Issues

The RMVS Specification will be a welcome measure to manufacturers wanting to help produce ventilators for the outbreak.  Manufacturers should, however, note that some points of clarification are still outstanding:

  • The MHRA recognises that flexibility is needed and will lead an exercise to define which standards can be ‘safely’ relaxed for this emergency situation. However, the outcome of this exercise has yet to be determined.
  • The RMVS Specification highlights several “unknown issues” caused by reduced requirements.  One example is whether the RMVS must have a backup battery.  MHRA flags that all current ventilators have backup batteries in case of mains electricity failure or to allow healthcare workers to unplug it from the wall to, for example, manoeuver the patient. MHRA still has to consider the balance between the risk to the patient and the potential burden to manufacturers to source huge numbers of large, heavy batteries in a short space of time.  The latter may defeat the RMVS Specification’s purpose to support the UK’s healthcare system with as many ventilators as possible.

MHRA has not provided a timeline for when it will provide further guidance on these points.  It is, however, continuing to seek advice from experts such as anaesthesia and intensive care medicine professionals, medical device regulators and electronic engineers to finalise the RMVS requirements.

On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.

The Department of Education and Cabinet Office has published guidance on key workers for COVID-19.  The guidance prioritises those who work in sectors considered as critical to the COVID-19 response, including workers involved in the food production, processing, distribution, sale and delivery, as well as those essential to the provision of other key goods (for example, hygienic and veterinary medicines).  Other key workers include those in health and social care, education and childcare, local and national government etc..  Children that cannot be kept safely at home will have their education prioritised if they have a parent who is considered a key worker.

Whilst DEFRA works closely with the food and drink industry to monitor the situation and impact of the food supply chain, the government agency has introduced measures such as extending delivery hours to supermarkets to allow a higher frequency of deliveries to stores to ensure that shelves are replenished more quickly.  A temporary relaxation of the enforcement of EU drivers’ hours rules also began from 00:01 on 18 March 2020 to last until 11:59 on 16 April 2020.  This applies solely to drivers involved in the supply of food and other essential products to supermarkets.

New home delivery guidance was issued on 18 March 2020 by the Association of Convenience Stores (“ACS”) on how to safely conduct local grocery deliveries to support those that are self-isolating.  The guidance explains what regulations apply to those thinking of opting for home deliveries and provides simple advice on how to conduct deliveries in a way that best promotes good hygiene and minimises the risk of passing on COVID-19, amongst other viruses.

In response to the evolving situation and requests from retailers, the government plans to outlay legislation next week to relax elements of competition laws temporarily so that retailers can collaborate on contingency plans and share resources as necessary during this period.

The Competition and Markets Authority (“CMA”) has launched a taskforce today in order to monitor the government’s plan to relax competition law and warns firms suspected of exploiting these exceptional circumstances through unjustifiable prices or misleading claims.  The CMA has already contacted traders and platforms regarding excessive pricing of hand sanitiser.  The taskforce will enable the CMA to advise the government on emergency legislation and how to ensure competition law does not stand in the way of legitimate measures that protect public health as “[t]his is obviously a time when we all have to behave responsibly to protect our fellow citizens, and particularly those who are most vulnerable.  We urge retailers to behave responsibly in the exceptional circumstances of the COVID-19 outbreak” (Andrea Coscelli, Chief Executive Officer of the CMA).

The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country.

On January 19, 2020 the Ukrainian authorities informed the World Organization of Animal Health (“OIE”) of an outbreak of HPAI in the village of Bugakiv, in the Nemyriv district of Vinnytsia Oblast (region).  As a result of this, all imports of poultry meat from Ukraine into the EU were effectively banned, as exporters could no longer meet the requirements of Commission Regulation 798/2008.

That Commission Regulation requires that every consignment of poultry meat from Ukraine be accompanied by a veterinary certificate signed by an official veterinarian declaring that the meat comes from a territory in Ukraine listed in Part 1 of Annex I to the Commission Regulation that is free from HPAI and other diseases.  As a result of the HPAI outbreak in the Nemyriv District of Ukraine, Ukrainian veterinary officials could no longer declare that any consignment of poultry meat from Ukraine came from an Ukrainian territory listed in Annex I free from HPAI.  Thus, no imports of Ukrainian meat into the EU could be authorized.

In response to the HPAI outbreak, Ukrainian authorities implemented a stamping-out policy to control and limit the spread of HPAI.  They also submitted information to the European Commission on the epidemiological situation in Ukraine and indicated the areas placed under restriction.  The Ukrainian authorities made use of Article 65 of the EU-Ukraine Association Agreement, which establishes a special procedure for the recognition of regionalization decisions following a disease outbreak in Ukraine.  Such regionalization allows for the division of the country into separate zones so that one (usually smaller) part of the territory cannot be considered free from HPAI, while the rest of the country can.  Following this, the European Commission’s Standing Committee on Plants, Animals, Food, and Feed (the “PAFF Standing Committee”) voted in favor of amending Part 1 of Annex I to Regulation 798/2008 to reflect these two new zones.

The adopted Regulation only bans imports of poultry from a limited area, composed of a number of municipalities, including that of Bugakiv village itself, and surrounding areas in the Nemyriv district.  Major centers of commercial production of poultry meat in Ukraine fall outside the prohibited zone.  This is a significant improvement with respect to prior outbreaks, when the operation of Commission Regulation 798/2008 effectively banned imports from entire regions (“Oblasts”) of Ukraine.

The new Regulation also removes the ban against imports of poultry meat from the regions of Kherson, Odessa, and Chernivtsi.  These regions were banned from exporting poultry meat to the EU during the prior outbreak of HPAI in Ukraine in 2016 – a ban that had not since been lifted.

The Regulation will enter into force on March 7, 2020.  It will allow Ukraine to effectively make use of the additional duty free quota of 50,000 tons of poultry meat per year that it obtained under the Agreement on Poultry that the EU and Ukraine concluded last year.

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.

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 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:

  1. 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.
  2. 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.

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:

  1. create a federated European health data space with appropriate privacy protections;
  2. support the development of smart health products and services;
  3. adapt regulations and standards with the aim of “advancing standardization and interoperability of healthcare data”;
  4. promote skills for the development, uptake and effective use of smart health products and services;
  5. stimulate the demand-side and the uptake of smart health products and services; and
  6. 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.

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.

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.”