This page was last updated on 26 May 2020.
The life sciences industry has, understandably, been at the forefront of discussions regarding the global COVID-19 pandemic, with evolving pressures and challenges on governments, the healthcare system and drug developers.
Due to the scale and nature of the crisis, governmental, regulatory and corporate pragmatism is proving fundamental to overcome the challenges of undertaking research and testing of potential treatments and vaccines of COVID-19. As just one example, on 14 April 2020, GSK and Sanofi announced their intention to collaborate on a vaccine for COVID-19. This partnership between two pharmaceutical sector competitors represents, in these unprecedented times, being "in this together" and more collaborations in the industry seem likely in coming weeks. The Government meanwhile has announced the creation of a vaccine taskforce, with representatives from academia and industry, and is working closely with the Bioindustry Association. Together with the regulatory changes and flexibilities noted below, albeit temporary, the global pharmaceutical sector is working together in seeking to overcome this emergency.
Regulators' Guidance and Priority Frameworks
Regulators worldwide have put in place a number of updated measures and revisions to their regulatory requirements designed to support the rapid development and approval of vaccines and treatments for COVID-19. For example, the European Medicines Agency (EMA) has a number of mechanisms to speed up development and approvals of COVID-related medicines, such as the PRIME scheme, accelerated assessment and conditional marketing authorisations. It is in discussions with a number of developers of potential treatments and vaccines and is providing scientific advice free of charge for potential novel treatments or vaccines with a number of clinical trials approved and underway.
In order to coordinate the development, authorisation and safety monitoring of treatments and vaccines intended to both treat and prevent COVID-19, the EMA has established the COVID-19 EMA pandemic Task Force (COVID-ETF) to take quick and co-ordinated regulatory action during the pandemic. COVID-ETF's primary goal is to assist EU Member States and the European Commission with COVID-19 related research and development, avoid duplication of knowledge and, where appropriate, assist with collaborative research and testing between EU Member States and corporate entities.
The EMA, the European Commission and the national competent authorities have issued a Q&A detailing its regulatory expectations and flexibilities during the pandemic in relation to marketing authorisation procedures, manufacturing and importation of finished products and active pharmaceutical ingredients, quality variations, product information and labelling.
Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), working alongside the Department of Health and Social Care (DHSC), is prioritising the support and authorisation of vaccines, clinical trials of new medicines, and supply management in relation to medicines and healthcare products. It has adopted a number of expedited procedures alongside regulatory flexibilities to allow it to be as pragmatic as possible in areas including blood components for transfusion, clinical trials, inspections and good practice, medical devices, medicines regulation and pharmacovigilance.
Whilst the current focus is on implementing trials for the investigation of new treatments for COVID-19, there is also a need to mitigate the negative effects of the pandemic on ongoing and planned clinical trials. The EMA has issued guidance for sponsors on clinical trial management setting out necessary adjustments and protocol deviations arising from, for example, the need to isolate participants, limit access to public spaces, and the reallocation of healthcare professionals, whilst also ensuring the safety of trial participants and preserving data quality.
The MHRA has also put in place expedited scientific advice and rapid reviews of clinical trial applications to support manufacturers and researchers. In addition to guidance on clinical trial applications for COVID-19, it has issued guidance in relation to the conduct of clinical trials generally where issues may arise as a result of COVID-19. Whilst the MHRA is clearly aiming to be as flexible and as pragmatic as possible on regulatory requirements, it stresses that the safety of trial participants remains the first priority.
Sponsors should review the EMA and MHRA guidance, alongside any other relevant specific national legislation and guidance, and travel restrictions etc.
The impact of the COVID-19 pandemic on ongoing and new clinical trials has been felt by sponsors globally. The likelihood of new non-COVID-19 clinical trials commencing in the next six months is extremely low given the closure and repurposing of trial sites, suspension of trial participant recruitment, and limited availability of diagnostic testing. It has already been seen that any non-COVID-19 clinical trials already underway are limited to existing trial patients, often supported by site transfers, with the wider clinical trial delayed and a postponement on new trial participants. Extended delays in the completion of clinical trial programmes due to COVID-19 may well lead to a number of clinical trial programmes potentially being withdrawn. If this becomes a significant issue, it can be anticipated that pharma companies will be actively lobbying the regulatory authorities to address the situation.
The MHRA has confirmed that will only be conducting essential on-site Good Practice inspections but that it expects organisations to maintain GxP compliance. It is allowing alternative courses of action for manufacturing or laboratory equipment during the crisis, and exceptional flexibilities on good distribution practice for wholesalers.
Supply disruptions and shortages are of critical concern in the face of increased demand for certain medicines. Shortages are arising for a range of reasons including temporary lockdowns of manufacturing sites, travel restrictions impacting exports, bans on exports in some jurisdictions, and stockpiling (at all levels of the supply chain).
The EMA has announced EU-level measures to help prevent and mitigate supply issues. This includes enhanced co-operation with the pharmaceutical industry in monitoring supply and regulatory actions, and the launch of the i-SPOC (industry single point of contact) system which will allow companies to report any supply issues directly to the EMA. Whilst medicine shortages are dealt with at the national level (and will continue to be reported to the Member States concerned), the EMA is co-ordinating this centrally.
The European Commission has also set out the steps it has taken on a range of issues to ensure the availability of supplies and equipment. These include a Joint Procurement Agreement in relation to medical and protective equipment, guidelines to ensure continued supply of vital medicines, increasing European production capacities of essential equipment and materials, export authorisations, and temporarily lifting customs duties and VAT on imports of medical devices and protective equipment from third countries.
The Commission has also published a Temporary Framework Communication providing anti-trust guidance to companies in relation to co-operation over responses to the pandemic, e.g., in relation to production stock management and distribution. Such co-ordination would ordinarily be potentially contrary to competition law, but the Temporary Framework provides guidance on conducting such co-operative arrangements, with appropriate safeguards. Whilst co-operation projects within the framework will not breach competition law, the Commission reiterates that these are exceptional circumstances, and it will be closely monitoring market developments and attempts to take advantage of the situation to breach competition law.
Whilst companies must themselves assess the legality of their practices, the Commission is providing oral guidance as well as written comfort letters concerning specific co-operation projects. The Commission has already provided a comfort letter to Medicines for Europe in relation to a co-operation project targeting the risk of shortage of critical hospital medicines, which are largely generic medicines.
The European Commission has published Recommendation (EU) 2020/403 inviting economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities, to deploy all possible measures to ensure supplies of PPE and medical devices in the EU match the continuously increasing demand. This includes, for example, market surveillance authorities allowing appropriate PPE or medical devices to be made available on the EU market (for a limited time and whilst necessary procedures are carried out) even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised. It has also issued guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices; and guidelines on in vitro diagnostic tests and their performance.
The MHRA has confirmed that it may authorise the supply of a non-CE marked device in the interests of health protection. It has also issued guidance on COVID-19 tests and testing kits, clinical investigations, and the regulatory status of equipment being used to help prevent COVID-19 (such as hand gels and PPE).
In the meantime, the industry was already concerned at the impact of the impending changes to the regulatory regime for medical devices from 26 May 2020, when the Medical Devices Regulation was due to apply. On 2 April, the European Commission proposed that application of the Regulation be postponed for one year, i.e., until 26 May 2021. The Commission's proposal does not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022. The Commission says that its proposal will allow health institutions and economic operators in Member States to prioritise the fight against COVID-19, whilst continuing to ensure patient health and safety until the new legislation enters into force. It will also avoid any regulatory or other hurdles arising from implementation of the new regime adversely impacting on supply. The final text of the Regulation was approved by the European Parliament and Council on 20 April 2020, and it was published in the Official Journal and came into force on 24 April 2020.
As concerted efforts continue globally to implement new medicines and vaccines, questions have arisen over possible conflicts with national and regional patent law and other IP regimes. An international group of IP lawyers and scientists have proposed an 'Open COVID Pledge', calling upon organisations to pledge to make their IP that is relevant to COVID-19 available free of charge under the terms set out in its template licence (organisations can revise the template). Many well known organisations in a range of industries have made the pledge by, for example, posting a notice to that effect on their website. The licence would remain in effect until one year after the WHO declares the pandemic to be over. The pledge does not address any data rights that may arise.
The UK's patent legislation provides mechanisms such as compulsory licensing of patents (albeit this only applies where certain criteria are met) and Crown use of patents during a period of emergency. It has also been reported that the Government has agreed to indemnify manufacturers of rapidly manufactured ventilator systems against infringement of third party IP rights and also in relation to product liability claims.