COVID-19: A Global Review of Healthcare and Life Sciences Industry Issues
Last updated: 16 April 2020
(a) How has the regulator in charge been addressing the urgent need for medicines, medical devices and medical supplies? Has the focus been on a faster review and the granting of marketing authorizations, the exception to or relaxation of import/use/ licensing restrictions, or any other available mechanisms?
For context, the Malaysian government imposed a Movement Control Order (MCO) on 18 March 2020 to curb the spread of COVID-19 across Malaysia which has since been extended to 28 April 2020. Notwithstanding this, to address the urgent needs for essential items such as medical devices and supplies, companies manufacturing these essential items are able to continue their operations during the MCO period, subject to the approval of the Ministry of International Trade and Industry. To address the pressing necessity for medical equipment and supplies, the government and its agencies have provided the following:
Please also refer to our responses to the next question for the special mechanisms introduced by government authorities in relation to the marketing authorizations and licensing restrictions.
(b) What opportunities and challenges has the COVID-19 outbreak brought for market access in terms of regulatory approval?
In respect of medical devices which are required to be registered under the Malaysian Medical Devices Act 2012, to bypass the typical lengthy process of regulatory approval, companies can apply for exemption from registration requirement with approval from the Malaysian Medical Device Authority (MDA). In order to safeguard an adequate supply of face masks, MDA announced that companies can apply for exemption from registration for face masks through a Notification of Medical Device for Special Access. Exempted face masks are not allowed to be advertised publicly and must be sold to authorized health premises or pharmacies only.
Since the COVID-19 outbreak, MDA has exempted COVID-19 test kit brand Wondfo from registration requirements to assist medical staff in combating COVID-19 outbreak in Malaysia. These exempted kits are limited to professional use by staff in hospitals and health laboratories. Another notable MDA exemption was for the importation, distribution and sale of personal preventive equipment used by the frontliners to prevent or reduce the risk of transmission and infection of germs.
In relation to general market access of medical devices, selected rapid test kits from United States and South Korea are pending approval and certification as they are currently being tested by the MOH. There is potential for increased market access for companies of these test kits as MOH has plans to purchase in large quantities if the results pertaining to the accuracy of these test kits are promising.
(c) Other than impact felt for clinical trials (see Section 2 below) and IP risks (see Section 3 below), what challenges has the COVID-19 outbreak brought for market access in terms of regulatory approval?
In respect of other medical devices and pharmaceuticals which do not fall within the exemptions above or are not related to COVID-19, market access are generally not completely prohibited as most of the healthcare related government authorities remain in operation during the MCO and are open to online submissions. That said, market access for these products may be affected by potential delays in the timeline for regulatory applications, in light of the MCO and the need to prioritize approvals which relate to COVID-19.
In the same vein, the National Pharmaceutical Regulatory Agency (NPRA) has recently decided that all domestic and overseas inspections by NPRA scheduled for 2020 will have to be postponed to a later date. This will affect the market access for products of manufacturers who are required to comply with principles of Good Manufacturing Practice and Good Distribution Practice (GDP) as well as importers and wholesalers who are required to comply with principles of GDP.
(a) What have been the major impacts of the COVID-19 outbreak on the management of clinical trials?
The selection of Malaysia by the World Health Organisation (WHO) for the involvement of its global clinical testing to carry out the research on drugs identified as a possible treatment for COVID-19, saw clinical trials in Malaysia shifting their focus towards finding a possible treatment for COVID-19. This shift in focus is evidenced by the Medical Research & Ethics Committee (MREC) prioritising new COVID-19 studies for an immediate review as research involving human subjects requires prior ethics review and approval by MREC. Separately, Malaysia have also began testing of vaccines based on previous research on vaccines for Infectious Bronchitis virus. Since MREC’s review and approval of clinical trials involving human subjects is required before the trial is allowed to start, non-COVID 19 related trials is likely to experience an administrative backseat with the postponement of full-board reviews for all non-COVID 19 related trials until MCO term has ended. The shift in priorities and postponement of full-board reviews would result in a marked delay for the start of non-COVID 19 related trials as the majority of these trials are high risk studies requiring a full-board review.
(b) Have there been measures adopted by the regulator in charge to assist with clinical trial management whether in the interim or on an on-going basis?
The ongoing measures to assist with clinical trial management includes online registration of research and submissions for approval through the National Medical Research Register (NMRR), which would reduce the research review time and assist investigators to track the status of their research online. The online directory on the NMRR website, which lists participating investigators, also allows for investigators to locate other potential collaborators and sponsors of clinical trials to identify suitably qualified clinical investigators to participate in their multi-center trials. As mentioned above, the MREC will be prioritizing COVID-19 studies for an immediate review. Depending on the risks involved to the human subjects, the MREC will decide if the COVID-19 study will require either a full-board review or an expedited review that would be assessed by the chairperson.
(c) Are there any general tips and recommended solutions under the local regulatory framework?
For people who wish to start clinical trials related to COVID-19, it is advisable to register the study in NMRR and include “COVID” in the title of the study which would allow for the study to be forwarded directly to the MREC for review.
(a) Are there any state emergency supply measures for medicines, medical devices and biocides and what are the implications on IP protection of the product in question?
While compulsory licensing and "government-use" licenses are recognized under the Patents Act 1983, there has not been any compulsory or government-use licenses issued for drugs in relation to COVID-19. As stated earlier, Malaysia will carry out clinical trials to test selected drugs to combat COVID-19, which could trigger the possibility of a government-use license, depending on the type and cost of the original patented drug. Meanwhile, the Malaysian government has recently approved the import of 10 million facemasks from China.
(b) Are there any issued or discussions on the likely issuance in response to the COVID-19 outbreak in your jurisdiction?
Discussions on the likely issuance have yet to be seen as the focus has been primarily on clinical trials and testing.
(a) How has the COVID-19 outbreak changed the use and provision of telemedicine services? Are there any interim measures or anticipated legislative changes?
There has been more emphasis on the provision of telemedicine as seen with the collaboration of the MOH with the largest telemedicine platform in Malaysia, DoctorOnCall to launch a virtual health advisory portal to address rising number of public queries about COVID-19 and reduce congestion at medical facilities. The increased use of telemedicine services of the portal since its establishment is apparent as a growing number of people turn to telemedicine services as an alternative health advisory guide since the MCO started. Other telemedicine platforms such as Doc2Us have also been expanding the provision of telemedicine services by actively releasing informative guides on COVID-19 to the public at large. As of now, there are no anticipated legislative changes to the Telemedicine Act 1997 which provides for the regulation and control of the practice of telemedicine, though the legislation is still not yet in force.
Read more on: https://www.bakermckenzie.com/-/media/files/insight/publications/2020/04/covid19--a-global-review-of-healthcare-and-life-sciences-industry-issues.pdf
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