Belgium adopts export ban on certain medicines to non-EEA countries and other measures to avoid COVID-19 shortages

1. Summary

On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19. It applies for one month from 1 April, renewable. On 2 April 2020, the authority provided further details in a news post on its website. The decision implies:

An export ban to countries outside the European Economic Area (EEA). Exceptions must be expressly requested from the FAMPH.
Exports to EEA countries are prohibited unless notified beforehand to the FAMPH.
Sales quota for wholesalers.
Notification and possible reallocation of large stocks.

We briefly explain these measures, and review their lawfulness under EU law.

2. Medicines and raw materials covered

The Decision applies to medicines and raw materials mentioned in the Annexes. Here are some examples:

Annex I: medicines with a single active substance (e.g. intravenous diazepam and lorazepam, fentanyl, epinefrin…);
Annex II: medicines with more than one active substance (e.g. lidocainehydrochloride – methylprednisolon…);
Annex III: raw materials (e.g. amoxicillin, chloroquine, morfinehydrochloride…);
Annex IV lists medicines with a single active substance for non-intravenous use that are excluded (e.g. diazepam…).

3. Export notification to EEA countries

Article 3 (1^st and 2^nd indent) of the FAMHP Decision states that it is prohibited to supply medicines to anyone other than wholesalers established in Belgium, entities established in Belgium authorized to distribute medicines, or hospitals established in Belgium. Similarly, raw materials may only be supplied to wholesalers established in Belgium and entities established in Belgium authorized to distribute medicines.

As an exception to this general principle, supplies to another EEA member state are permitted if (1) the medicine or raw material are intended to be supplied in that member state, and (2) if a notification is sent beforehand to the FAHMP at coronashortages@fagg-afmps.be . The subject line should read: “Notification export EEA – Name of MA holder – Name of the medicine.” Under article 126 of the EU-UK withdrawal agreement, for the purposes of the FAMHP Decision, “EEA” should include the UK until 31 December 2020.

Under the current circumstances, the Belgian notification requirement likely complies with EU law given that it allows the FAHMP to monitor product flows. In this regard, Commission Guidelines of 16 March 2020 on COVID-19 and border management measures state at point 6 that: “Member States should preserve the free circulation of all goods. In particular, they should guarantee the supply chain of essential products such as medicines, medical equipment, essential and perishable food products and livestock. No restriction should be imposed on the circulation of goods in the Single Market, especially (but not limited to) essential, health-related and perishable goods, notably foodstuffs, unless duly justified….”

Hence, the Belgian notification requirement should not – in practice – amount to an intra-EEA export ban.

4. Export ban to non-EEA countries

As mentioned above, the FAMHP contains a general export ban. For non-EEA countries, the Decision did not provide for a specific procedure to request an exception. The news post on the FAMHP website of 2 April clarifies this. It states that an exception can be requested via email to coronashortages@fagg.be. The subject line should read: “Request Export outside the EEA – Name of MA holder – Name of the medicine.” The country of destination and the quantities should be mentioned.

The export ban is in a tense relationship with EU law. Article 1 of Regulation 2015/479 states that “[t]he exportation of products from the Union to third countries shall be free, that is to say, they shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with this Regulation.” Therefore, in principle, a Member State should request the European Commission to impose an export authorization at EU-level in order to prevent a shortage of essential products. When a member state makes such a request, the Commission should decide within 5 working days. It is unclear whether Belgium has consulted with the European Commission. Regulation 2015/479 and Belgium’s duty of loyalty to the EU interest (article 4(3) TEU) seem to require this kind of (prior?) consultation.

Article 10 of Regulation 2015/479 does permit Belgium to adopt quantitative restrictions on exports if these are justified on grounds of public health. Presumably this requires that due to urgency, it is not possible for member state to consult with the European Commission. Moreover, the export ban requires compliance with the principle of proportionality. Thus, when a company’s request for non-EEA export is refused, EU law no doubt requires that this is specifically motivated in light of shortages for exactly that product. A general reference to public health risk is not likely sufficient.

5. Supply quota

Pursuant to article 2 of the FAMHP Decision, manufacturers, wholesalers, wholesalers-distributors must limit sales of medicines and raw materials to an amount equal to the sales of the previous year for that period, increased with a coefficient of maximum 50%. Larger quantities may be supplied on prior notification to the FAHMP. Wholesalers may receive specific instructions for deliveries from the FAHMP. These measures too, must be checked for compliance with EU free movement principles on a case-by-case basis.

6. Re-allocation of large quantities of stock

Hospitals and entities authorized to distribute medicines that hold stocks of more than one month of sales volume (or raw materials for the preparation of sales volume of officinal or magistral preparations) must notify this stock to the FAHMP with the goal of possible reallocation. The sales volume is calculated based on sales of last year for the same period, increased with a coefficient of 50%.

European Commission publishes proposal to postpone the application date of the Medical Device Regulations in response to COVID-19

By Sarah Cowlishaw and Anna Herrmann on April 3, 2020 Posted in European Union, Food & Drug Regulatory, Medical Devices

The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here). The European Parliament and the Council will have to approve the proposal before the MDR’s current implementation date of 26 May 2020.

The Commission’s legal basis for the postponement are Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (“TFEU”). This gives the European Parliament and Council the authority to adopt measures that ensure the establishment and functioning of the internal market, and, in particular, set high standards of quality and safety for medicinal products and medical devices. The Commission also cites the principles of subsidiarity and proportionality, arguing that the measure will ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption:

“This Union action is necessary to achieve the objective of the proper implementation and application of [the MDR] by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis. The proposed amendment aims to ensure that the intended purpose of [the MDR], that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.”

The Commission confirmed that its proposal does not alter the MDR substantively and does not impose any new obligations on manufacturers or other concerned parties. InsideEULifeSciences will continue to monitor developments and publish updates as they come in.

European Commission publishes Guidance relating to COVID-19 and Public Procurement

By Katharina Ewert and Brian Kelly on April 2, 2020 Posted in Miscellaneous

The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis. The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement Directive 2014/24/EU. The Guidance highlights the following flexibilities, which authorities may wish to rely on in procuring urgently needed equipment and medicines in response to COVID-19:

Authorities may choose to rely on digital tools to facilitate a more effective procurement process;
In case of urgency and extreme urgency, the timelines for the open and restricted procedures may be significantly shortened; and
Authorities may rely on the negotiated procedure without publication allowing them to negotiate directly with one or more potential suppliers.

The last point is particularly relevant. The negotiated procedure without publication can ordinarily only be relied upon in certain very narrow circumstances. One of these circumstances includes “reasons of extreme urgency brought about by events unforeseeable by the contracting authority”, which makes compliance with the deadlines for other procedures impossible. In the Guidance, the Commission acknowledges:

“The specific needs for hospitals, and other health institutions to provide treatment, personal protection equipment, ventilators, additional beds, and additional intensive care and hospital infrastructure, including all the technical equipment could, certainly, not be foreseen and planned in advance, and thus constitute an unforeseeable event for the contracting authorities.”

Similarly, the Commission also accepts that the need has to be met as soon as possible, so that even the shorter timelines for the open or restricted procedures may be unsuitable. However, the Commission also notes that this would need to be assessed on a case-by-case basis and that urgency could not be invoked in the procurement ultimately takes longer than if any of the other procedures were followed. Finally, the Guidance also makes clear that this procedure should only be used to meet immediate needs and to “cover the gaps until more stable solutions can be found.”

The Guidance addressed to Member State authorities follows after 25 Member States had participated in a joint procurement for personal protective equipment by the European Commission and for which bids were received by the end of March (see here).

The Italian Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency

By Bart Van Vooren and Teresa Portelli on March 30, 2020 Posted in European Union, Food & Drug Regulatory, Medicinal Products

On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency. The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities. The Guidance is intended to ensure that activities related to clinical trials may still continue, despite the current situation.

The Guidance covers all the phases of clinical trials, i.e., submission of authorization requests of clinical trials; Ethics Committees’ evaluation; management of clinical trials outside investigational sites. The Guidance also provides some exemptions from the current EU and Italian legislation, i.e., management of the Investigational Medicinal Product; closure of a clinical trial site; clinical tests; clinical trial monitoring; reimbursement of exceptional expenses; possibility for Sponsors to enter into agreements directly with specialized agencies to carry out activities related to the management of patients. We provide further details below.

Submission of authorization requests of clinical trials

The Guidance provides for the postponement of submission of paper documentation and CD-ROM concerning authorization requests of clinical trials and substantial amendments. It also allows the submission of authorization requests by e-mail if the trials concern the treatment of Covid-19.

Ethics Committees’ evaluations of clinical trials/substantial amendments

Ethics Committees may arrange their meetings via web-conferences and other telematics ways.

Management of clinical trials outside investigational sites

The Guidance allows conducting clinical trial activities outside of investigational sites when this is necessary to limit the risk of coronavirus infection. In this case, Sponsors must notify a substantial amendment for immediate implementation to the competent Ethics Committee, outlining the urgency of the situation. Furthermore, Sponsors and CROs must prepare a risk evaluation plan and implement an action plan with the purpose to minimize contacts between patients and the staff, and to avoid to overload healthcare facilities.

As we mentioned above, the Guidance also provides some exemptions from the current EU and Italian legislation.

Investigational Medicinal Product. Where possible, it may be useful to supply an amount of the Investigational Medicinal Product for a period of time longer than is normally estimated. Under these circumstances, deliveries of the medicinal product may be arranged directly to patients, upon indications of the director of the hospital pharmacy and the principal investigator.

Closure of a clinical trial site. If a site is closed to the public for COVID-19 containment measures, it should be first assessed whether the clinical trial staff is able to guarantee the continuity of the trial. If it is not the case, the trial should be temporarily suspended or patients should be transferred to the nearest active clinical trial site.

Clinical tests. Hematological tests should be carried out in public health facilities. However, private sites should be chosen only when it is the only possibility for patients’ protection.

Clinical trial monitoring. Telephone contacts or videoconferences with the trial site staff are allowed provided that these are described in specific Standard Operating Procedures (“POS”) by the Sponsor/CRO and approved by the Data Protection Officer of the trial site.

Exceptional expenses reimbursement. Sponsors are allowed to directly reimburse patients, in case they incur additional expenses for the implementation of urgent measures.

Possibility for Sponsors to sign directly with specialized agencies to carry out activities related to the management of patients. Interestingly, in derogation from FAQ 11 of EMA’s “Q&A: Good clinical practice (GCP)”, Sponsors may enter into service agreements directly with specialized agencies or companies, g., home nursing services, to carry out activities related to the management of patients. Such activities must be carried out under the responsibility of the principal investigator.

AIFA makes clear that the Guidance remains valid until further notice.

Finally, it should be noted that on March 20, 2020, the European Medicines Agency published guidance on the management of clinical trials due to the current healthcare emergency. The EMA invites all the sponsors and investigators to consult the specific national legislation and guidance in place and to use them to complete the EMA’s guidance or, for specific matters, they make take priority over the EMA’s guidance.

European Commission plans to postpone the application date of the Medical Device Regulations in response to COVID-19

By Sarah Cowlishaw and Anna Herrmann on March 25, 2020 Posted in Food & Drug Regulatory, Medical Devices

The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year. This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak. According to the Commission spokesman, the goal is:

“to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the deadline for entry into force is at the end of May.”

This will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain. The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.

InsideEULifeSciences will continue to monitor developments and publish updates as they come in.

MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19

By Marie Doyle-Rossi and Anna Herrmann on March 25, 2020 Posted in Food & Drug Regulatory

On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with its international regulatory network.

‘Essential’ on-site inspections

GxP inspections ensure that UK and relevant overseas sites, engaged in laboratory studies, clinical trials, manufacturing, distribution, and pharmacovigilance, comply with MHRA standards of safety monitoring, product quality and accountability, amongst others.

The Agency is balancing the UK Government’s advice to limit on-site inspections to prevent the transmission of COVID-19 with the importance of ensuring compliance with MHRA standards. The MHRA clarified that it will continue to prioritise essential clinical trial authorisation applications. Also, for the foreseeable future, ‘essential’ on-site GxP inspections are:

(i) sites linked to the UK Government’s COVID-19 response; and
(ii) sites that pose a potential serious public health risk and cannot be assessed remotely.

On-site inspections, where necessary, will continue to operate as normal. This includes potential unannounced visits. During on-site inspections, MHRA inspectors will strictly follow all UK government public health measures to prevent the spread of COVID-19.

Remote protection of public health

The MHRA aims to monitor organisations’ compliance through its remote assessment procedures and communications with its international regulatory network. For example:

Office-based inspections. The MHRA will request inspected organisations to provide electronic copies of documents and other information for review off-site. Any follow-up will be conducted via email and teleconferences. Where necessary, an on-site inspection will be scheduled when travel restrictions are lifted.
Pharmaceutical Inspection Cooperation Scheme (“PIC/S”). PIC/S is a confidentiality arrangement between 53 global inspectorates, mutual recognition partners and other regulators. The MHRA will rely on inspection information shared by the network to monitor international organisations and their supply chains’ compliance.

Going forward

Notwithstanding the reduction in inspectorate on-site presence, the Agency expects organisations to maintain GxP compliance and be prepared to take “flexible and pragmatic approaches” to ensure the protection of public health. For organisations awaiting licences that usually require an on-site GxP inspection, it is not clear whether the MHRA will issue licences without an on-site inspection or if considerable delays should now be expected. As the situation evolves, the MHRA will continue to update organisations and their supply chains on its proposed approach.

TechForce19: UK Government promises up to £25,000 for innovator companies that develop digital support solutions for COVID-19

By Sarah Cowlishaw and Anna Herrmann on March 25, 2020 Posted in Uncategorized

On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable and self-isolating.

This will be of interest to any innovative companies able to develop and deploy technology in one of TechForce19’s three priority areas:

remote social care;
optimising staffing in care and volunteering sectors; and
mental health.

The proposed digital solutions should aim to address community problems, not clinical problems, and should not require integration with NHS systems. The technology may focus on, for example, delivery, recruitment and management of services to facilitate and ease pressure on one or more of the three priority areas during COVID-19.

TechForce19 has been launched by NHSx, the joint organisation for the digital transformation of the UK health and care system, which brings together the DHSC, NHS England and NHS Improvement. PUBLIC, a GovTech venture firm, will manage TechForce19 for no profit.

Interested companies can apply here.

Please note that developing these digital support solutions will likely raise a myriad of regulatory, privacy and commercial issues. Covington’s Digital Health team is here to provide support and would be happy to speak with any companies who wish to bring innovative and essential products to the market at this important time.

EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic

By Grant Castle, Robin Blaney and Marie Doyle-Rossi on March 25, 2020 Posted in Food & Drug Regulatory, Medicinal Products

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.

MHRA issues specification for a “Rapidly Manufactured Ventilator System” for use in hospitals during the COVID-19 outbreak

By Sarah Cowlishaw and Anna Herrmann on March 23, 2020 Posted in Food & Drug Regulatory, Medical Devices

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.

DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19

By Brian Kelly, Katharina Ewert and Hannah Berry on March 20, 2020 Posted in Competition, Food & Beverage, Food & Drug Regulatory

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).