Removing regulatory bottlenecks to the supply of COVID-19 products and services

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Women workers in a garment factory with medical masks on their faces sew protective masks during the COVID-19 virus pandemic.
Women workers in a garment factory with medical masks on their faces sew protective masks during the COVID-19 virus pandemic. Photo: Shymkent / Kazakhstan

From Iraq to Kenya to Mexico, many garment factories are shifting their production lines to manufacture face masks, responding to unprecedented demand triggered by the coronavirus (COVID-19) pandemic. This reminds us that businesses can adapt quickly to market changes—but only if procedures and approvals are simple enough that they can easily repurpose their activities. 

Many governments have taken regulatory measures to improve the supply of personal protective equipment (PPE) and medical equipment. These range from fast-tracking approvals for manufacturing and import of PPE to temporary realigning certification requirements for drugs and equipment. There is also an ongoing effort to facilitate telemedicine.

Many of these measures are temporary, but they serve as examples of how governments can facilitate business activity by simplifying requirements to start, conduct, or repurpose it. Both to support COVID-19 crisis management now and the recovery phase that follows, governments—particularly in developing countries—should reconsider their broader regulatory requirements to remove any unnecessary barriers for business operations while still safeguarding public goods like health and the environment.

Canada, for example, has put in place a fast-tracking approval system for companies that are redirecting their activities to manufacture, import, or distribute masks. The objective is to shorten the time to process these applications to just 24 hours. In the United States, the Food and Drug Administration (FDA) has issued emergency authorizations with less stringent requirements for PPE manufacturing approvals along with a moratorium on taking action against businesses that engage in production of PPE for the duration of the public health emergency.

In addition, temporary approvals for equipment such as respirators are helping address a lack of supply. They include, for example, the authorization of expired respirators that would otherwise not be allowed for use, and certification of similar equipment to be used as ventilators—such as anesthesia gas machines and positive pressure breathing devices. For example, Swissmedic, the Swiss surveillance authority for medicines and medical devices, has published exemptions for placing non-compliant medical devices on the market. Owing to the current “extraordinary situation,” the agency will guarantee that exemption applications are processed promptly and pragmatically for ventilators.

As some countries pass the peak of their infections and lift lockdowns, there is broad agreement that the gradual return of people to work will be possible only with extensive testing. In view of that, several countries have put in place measures to speed the market approval of COVID-19 diagnostic tests and antibody tests. Agencies in the European Union, the United Kingdom, and the United States have all put in place accelerated assessment and conditional marketing authorizations.

In order to eliminate unnecessary patient contact and ease the burden on hospitals, countries are also relaxing the requirements for provision of telemedicine services. The United States has broadened access to telehealth services so that beneficiaries can receive a wider range of medical services without having to travel to a health care facility. In Germany, the Health Innovation Hub established by the Ministry of Health has published a list of trusted telemedicine services (including costs, reimbursement policy, functionality, and prices) that can be easily integrated into a doctor’s practice without technical know-how or hardware investment.

To facilitate access to information, several countries have put in place an online focal contact point providing information and facilitating businesses’ engagement in activities that can help mitigate shortages and increase availability of COVID-related supplies and devices. The FDA, for example, has announced the process for making guidance documents available to the public.

A cumbersome regulatory environment can exacerbate a crisis like COVID-19, so governments urgently need to create a sensible and effective regulatory framework to support their response. The pandemic is an opportunity to eliminate many regulatory barriers that were never justifiable. A speedy review of regulatory requirements for simplification and acceleration of approval of core products and services to fight the virus is an important step in the right direction.

Authors

Andreja Marusic

Global Lead for Business Environment

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