Darryl Bernstein, partner and head of the Healthcare Industry Group, and Rui Lopes, associate and member of the Healthcare Industry Group at Baker McKenzie in Johannesburg write:
The increase in the number of legal and regulatory measures arising out of COVID-19, and aimed at combatting its spread, is truly proportional to the growth of the pandemic. Although the measures affect all industries, many of these have direct implications for the healthcare and life sciences sectors. While some industries and services are forced to shut down, companies in the healthcare and life sciences ambit have been pushed to work even harder, innovate faster, collaborate and be more resilient, all at an unprecedented pace.
The COVID-19 pandemic has resulted in an urgent need for access to medical supplies and facilities. The South African government has been active in its response to securing public access to facilities and treatments, and to aid in the formulation of a cure for the virus, despite certain scathing reports of corruption and tender irregularities in some instances. Some of the main actions affecting the healthcare and life sciences sector have been set out below.
Regulatory Approach
South Africa’s regulatory approach has been to ensure that healthcare associated entities, including the medical associations, research facilities and pharmaceutical entities, are able to work in unison, essentially "singing from the same hymn sheet" when it comes to combatting the spread of COVID-19. This approach was adopted in order to ensure that the impact of the virus in all medical spheres would be effectively and adequately responded to.
National Treasury
The National Treasury issued an instruction note to government departments, municipalities and entities to help speed up the procurement of goods and commodities required to reduce and control the spread of the COVID -19 virus, which would naturally include medical-related products. This instruction note lists the prices of goods/commodities, to curb any opportunistic use of the State of National Disaster to drive profit margins. The instruction note is limited to goods required to limit the spread of the virus and will be terminated at the end of the State of National Disaster or when the National Treasury retracts the instruction note. It should be noted, however, that to date no procedural requirements have been relaxed in any sphere, including medication and devices.
Department of Trade, Industry and Competition
The Department of Trade, Industry and Competition issued the Exemption for the Healthcare Sector Regulations, which enabled healthcare players to cooperate on ensuring that there was adequate capacity and stocks at healthcare facilities throughout the country in order to respond to COVID-19.
South African Health Products Regulatory Authority
The South African Health Products Regulatory Authority (SAHPRA) adopted various scientific reviews of new medicines and vaccines through a priority review process. It has also sought to implement a Special Access Programme for practitioners treating COVID-19 patients, as well as to ensure that a speedy review of clinical trials for new vaccines or repurposed antivirals will be implemented.
Medical Supplies
SAHPRA has sought to adopt tactics to minimise and potentially prevent shortages and stockpiling of medicines or Active Pharmaceutical Ingredients (APIs). SAHPRA has been identifying alternative medicine or API suppliers and (when necessary) fast-tracking their regulatory approval, authorising the importation of unregistered products, substituting products with equivalent clinical indications, guiding rational prescribing, and prioritising medicine access for the most vulnerable. Pharmaceutical and medical device manufacturers and suppliers have also had to notify SAHPRA of any anticipated disruptions in supply as soon as possible in order for the authority to make contingency plans.
The South African Pharmacy Council and Regulatory Affairs Association has also been working proactively with institutions in terms of research to develop a vaccine as a matter of urgency. Moreover, they are issuing updates on the status of medicinal supplies and have called upon the public not to bulk buy purchases of essential supplies and medical items.
Medical Trials
South Africa is one of 10 countries involved in a global trial announced by the World Health Organisation to identify the most effective treatment for COVID-19. South African health sciences faculties are involved in this programme and the work involves many of the country's senior clinicians and researchers across specialties, such as infectious diseases and intensive care. The Southern African Pharmaceutical Regulatory Affairs Association and ethics committees are urgently reviewing potential therapeutics so that there are no regulatory delays.
The University of Cape Town, the Council for Scientific and Industrial Research, and Biovac are currently conducting research to develop a potential vaccine against COVID-19. The Department of Science and Innovation has allotted R12m and will redirect an additional R30m to further the development of a vaccine for COVID-19.
Telemedicine
The COVID-19 outbreak has changed the use and provision of telemedicine services. Prior to the COVID-19 outbreak, the use and provision of telemedicine services were only allowed in circumstances where one healthcare practitioner remotely assessed a patient, where the patient was in the physical presence of another healthcare practitioner. In terms of the Telemedicine Guidelines (issued by the Health Professions Council of South Africa (HPCSA)), "telemedicine" is defined as medical practice using electronic communications or other electronic means between an HCP in one location and an HCP in another location for purposes of facilitating, improving and enhancing clinical and scientific healthcare and research.
According to the Guidelines, the South African regulatory regime did not envisage the provision of health services from one HCP to a patient, without another healthcare practitioner being in the presence of the patient. In particular, all telemedicine services should involve an HCP where there is an actual face-to-face consultation and physical examination of the patient.
However, on 26 March 2020, and given the unique challenges of COVID -19, the HPCSA permitted the use of telemedicine for managing patients remotely, using virtual platforms, including video and telephonic links, as follows: The use of telehealth is restricted to already established relationships (practitioner-patient relationship). Telephone and/or virtual consultations for new patients are discouraged.
The HPCSA noted that the revised provisions on telemedicine are only applicable during the COVID -19 pandemic, and the revised Telemedicine Guidelines will continue to be used after the end of the pandemic.
Conclusion
While the impact of the pandemic is far from over, South African efforts to ensure that its citizens are able to access proper treatment and benefit from potential cures are on par with, and in many cases better than, other government responses around the world. While the healthcare system in South Africa faces many difficult challenges, and the numerous incidents of corruption which must be fully addressed, the government’s response to the containment of COVID 19 was recently applauded by the World Health Organisation.
As spread of the virus is expected to continue in the new normal under Alert Level 1, it is essential for businesses operating within the healthcare and life sciences sector to keep abreast of regulatory developments.
Issued by AMPR
[link url="http://www.treasury.gov.za/comm_media/press/2020/20200319%20Media%20statement%20-%20COVID-19%20Procurement%20Instruction%20Note.pdf"]National Treasury instruction note[/link]
[link url="http://www.thedtic.gov.za/wp-content/uploads/43114.pdf"]Regulations[/link]
[link url="http://www.sahpra.org.za/wp-content/uploads/2020/03/Report-Shortages_FINAL_17March.pdf"]Special Access Programme[/link]
[link url="https://www.hpcsa.co.za/Uploads/Events/Announcements/APPLICATION_OF_TELEMEDICINE_GUIDELINES.pdf"]HPCSA announcement[/link]