This week, we look at guidance for industry in the EU, UK and US in respect of medical supplies considered central to the fight against COVID-19: medical devices, medicines, PPE and hand sanitizer. This blog considers the introduction of new infrastructure and the relaxation of existing regulatory requirements, and builds on our previous blogs since the beginning of the crisis, including overall considerations for pivot of manufacture and past EU and UK guidance.
The European Commission, charged with coordinating the EU’s response to COVID-19, has a dedicated webpage setting out its current initiatives and guidance for manufacturers.
The Commission has introduced some systemic changes to assist with the fast manufacture and supply of medical devices in Europe, including:
- Postponing the application of the EU’s new medical devices regime by one year, to May 2021 (read more about this important update in this blog post);
- Establishing a ‘clearing house for medical equipment’ to match companies producing additional medical devices and PPE with Member States in need of this equipment, including by mediating any technical or regulatory obstacles, to ensure quick delivery;
- Lifting customs duties and VAT on imports from outside the EU;
- Confirming that a derogation within the medical devices regime can be relied on by Member States to avoid full conformity assessment procedures for new devices where there is a strong justification and a lack of suitable alternatives.
Q&A on Regulatory Expectations for Medicinal Products for Human Use
Together with the European Medicines Agency (“EMA”), the Commission has published a Q&A for marketing authorisation holders of medicinal products (“MAH”) on regulatory expectations and flexibility during the COVID-19 crisis.
Key steps included in this Q&A are as follows:
- Expediting marketing authorisations for medicinal products designed to assist with the treatment of COVID-19;
- Allowing justified requests for postponement of renewal applications for MAH with difficulties meeting deadlines;
- Allowing deferral of full assessment to variation of supplier/manufacturing/control sites for medicines crucial to treat COVID-19 patients in certain circumstances, by making available an exceptional change management process (“ECMP”). To benefit from this, manufacturers must notify the national competent authority that granted the marketing authorisation, or the EMA, of their intention to rely on the ECMP;
- Allowing Member State authorities to exercise increased flexibility on labelling requirements for essential medicinal products where there is a severe problem with the availability of the product.
Guidance on Conformity Assessment Procedures for Protective Equipment
The Commission has also published Guidance for prospective manufacturers of personal protective equipment (“PPE”). This Guidance is primarily aimed at companies who were not previously operating in this space, but may wish to start producing face masks, aprons, gloves and other PPE in light of the current pandemic. For more information, please see our previous blog post here.
Medicines and Healthcare products Regulatory Agency (“MHRA”) Initiatives
The MHRA webpage sets out specific guidance for industry on the flexible approaches it is taking towards regulation during the COVID-19 outbreak.
The MHRA has announced a series of initiatives for the regulation of medical devices in light of COVID-19, including:
- Working with the Office for Product Safety & Standards and the Health and Safety Executive (“HSE”) to significantly reduce product assessment timeframes, particularly for PPE , while “maintaining regulatory rigour”;
- All COVID-19 enquiries are being prioritised ahead of the agency’s standard targets;
- As previously reported here, exceptional use applications are being processed to ensure a continued supply of non-CE-marked medical devices, where: (i) there is a significant clinical need, and (ii) no CE-marked device available.
Initiatives to increase the production of hand sanitizer
Whilst the lack of EU-wide initiatives means companies producing hand sanitizer are grappling with complex national regulatory hurdles for “active substances” still under review, the UK has introduced some provisions to assist with supply:
- as part of its regulation of biocides, the HSE has introduced a derogation for certain Proponal-2-ol based hand sanitizers that meet the WHO-recommended formula requirements. Confirmation that the derogation applies to products must be given by the HSE before the derogation is relied upon. The HSE has also indicated it may consider relaxation of requirements for active substance suppliers to appear on the Article 95 list, where every effort is made to use ingredients that ensure compliance with obligations otherwise;
- HMRC has relaxed certain tax/customs requirements for supply of the active substances used in these products which, as alcohols, are often subject to strict quantity limitations.
Indemnification of manufacturers of Rapidly Manufacturers Ventilator Systems
The UK government has taken the unusual step of deciding to indemnify certain stakeholders in the production of Rapidly Manufactured Ventilator Systems (“RMVS”), in an effort to scale up the production vital to the NHS efforts. In certain, limited, circumstances, this may include product liability indemnities, which are subject to individual negotiations between suppliers and the Government, and may assist companies, especially where new activities fall outside the scope of their existing business activities and insurance policies.
Watch this space for details of our upcoming webinar, which will cover liability and insurance issues that may arise for stakeholders during the COVID-19 crisis.
In the US, the Food and Drug Administration (“FDA”) has focused on offering guidance on conservation strategies to avoid product shortages and issuing Emergency Use Authorizations (“EUAs”) to expedite the commercialization of medical devices for the duration of the COVID-19 public health emergency.
The FDA has issued EUAs across its regulated product base. EUAs are updated daily (available here) and have covered:
- In vitro diagnostic tests, including those for SARS-CoV-2 and for COVID-19 antibodies;
- PPE, including respirators, face shields, masks, gowns and gloves;
- Ventilators and accessories, including modified use of anesthesia and positive pressure breathing devices for use as ventilators;
- Extracorporeal blood purification devices;
- A Temporary Policy (rather than an EUA) permitting the compounding of alcohol-based hand sanitizers
Other therapeutic devices running in short supply, such as renal dialysis systems, will likely be covered in forthcoming EUAs.
3D Printing of Medical Devices
Recognizing that some facilities and providers might be turning to alternate methods of manufacture, the FDA has also issued Frequently Asked Questions guidance on the use of 3D printers to make PPE and components for medical devices.
Development of COVID-19 treatments
In addition to stepped-up monitoring to prevent supply chain shortages of approved drugs and biologics, the FDA has created a special emergency Coronavirus Treatment Acceleration Program, or CTAP (available here), to expedite investigational use of drugs and biologics to treat COVID-19 and its related sequellae.
For development stage companies, the FDA issued guidance earlier in March (see our Alert) which is being used by sponsors and clinical trial sites to navigate the completion of clinical trials and maintenance of data integrity in a time of unparalleled global challenge to the healthcare system.
International regulators continue to produce a significant volume of guidance, which is changing the product safety regulatory landscape on a daily basis. This unprecedented output is extremely helpful to companies involved in the supply of medical supplies central to the fight against COVID-19; allowing them to address the immediate needs of the crisis effectively. As well as keeping up to date with current changes, companies should bear in mind that regulators’ targeted relaxation of rules does not necessarily mean that broader deviations will be viewed sympathetically. Moreover, companies should consider a long-term strategy that contemplates the post COVID-19 regulatory environment in which the current flexibilities will likely cease to exist, and product liability claims may materialise.
Cooley’s life sciences experts are available to advise on the most up-to-date position, and assist with short-term measures and long-term strategy to ensure that stakeholders are optimally-positioned for the current crisis, and for the future.