European legal issues stemming from the COVID-19 pandemic: regulatory, intellectual property, contract and competition law relevant to cell and gene therapy products.
Cell & Gene Therapy Insights 2021; 7(1), 35-43
On 30 January 2020, the Director-General of the World Health Organisation (WHO) declared the SARS-CoV-2 outbreak a public health emergency of international concern 1. At the time, there were 98 reported cases in 18 countries outside China and no deaths outside China. By 11 March 2020, the WHO declared COVID-19 a global pandemic with 118,000 reported cases in 114 countries and over 4,000 deaths 2. As at 14 January 2021, there were over 91 million global confirmed cases of COVID-19, including over 1.9 million deaths reported to the WHO 3. The speed and impact of this pandemic has been unprecedented. In this article, we consider some of the legal challenges and considerations that have arisen during the COVID-19 pandemic, with a focus on Europe, and explore how this has impacted the biopharmaceutical industry in its drive to develop vaccines and treatments for COVID-19, with a particular emphasis on the impact to the cell and gene therapy industry.
REGULATORY & PROCEDURAL CHALLENGES
Given the broad nature of regulatory challenges for the biopharmaceutical industry as a whole stemming from the COVID-19 epidemic, this section focuses on the challenges specific to the cell and gene therapy industry. The regulatory environment surrounding advanced therapy medicinal products (ATMPs) is already complex, with a number of interlocking regulatory regimes, a complex global supply chain, and difficult reimbursement environment. There are also particular difficulties in conducting trials in small patient populations suffering from rare diseases. The combination of small patient populations and the ATMP regulatory environment already puts strain on the authorization and launch of such products; the COVID-19 pandemic has only increased these complications.
ATMPs are often developed to treat small patient populations. This means that randomized controlled trials are difficult to run. Instead, small patient numbers are enrolled in clinical trials, which are often supplemented by post-marketing obligations and/or the collection of real world data. The treatments are also novel, developed to treat rare diseases, meaning a number of precautions are often built into the protocol to monitor unforeseen adverse reactions and ensure the safety of patients. Conducting such trials is already difficult, even without the additional stain of a global pandemic.
At the start of the pandemic, clinical trials in many countries were stopped. The Commission and EMA issued guidance for clinical-trial sponsors on how they should adjust the management of clinical trials during the pandemic to enable trials to continue 4. For example, it may be necessary for the protocol to be amended to change recruitment practices or to include social distancing measures, quarantine and self-isolation requirements, or mHealth and telemedicine aspects could be incorporated to minimize travel or to reduce interactions between healthcare professionals and patients. While these difficulties have affected all clinical trials, the impact is arguably greater for trials involving small patient populations, spread across the globe, which is often the case for certain ATMP trials. Further, many of the patients involved in ATMP trials may be vulnerable or have been told to shield during the pandemic, meaning their willingness to be part of a clinical trial may have changed.
Logistical difficulties and delays with clinical trials also put a strain on the marketing authorization process for ATMPs. Given the small patient numbers that are involved in many ATMP trials, there had already been pre-pandemic discussions among authorities on the level of data that is required for authorization of these products, and the extent to which gaps in the data can be supplemented post-marketing. Further delays in clinical trials, and reduced numbers of subjects due to COVID may exacerbate these data difficulties and lead to further delays in marketing authorization.
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