BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.
Clinical trials for oncology drugs have been hit hardest. Patients have found it difficult or impossible to visit hospitals for pre-screening or to see their physicians and get their medications regularly. For example, Beigene Ltd.’s clinical trials of tislelizumab were reportedly disrupted.
Xiaobin Wu, Beigene’s general manager for China, told BioWorld previously that keeping hospital operations orderly is essential to ensure clinical trials continue. Drugmakers have tried to keep their clinical trials moving by all means.
“We see a lot of pharmaceutical companies trying to deliver drugs to the patients. While it is not a direct impact of the outbreak, it’s a side effect that cannot go unnoticed,” Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), told BioWorld.
He said health authorities in China have already proposed restoring order at hospitals to respond to the disruptions on the clinical front.
A former health care official himself, Song and his association have made suggestions to regulators about how to support ongoing clinical trials and handle potential delays in drug approvals.
In early March, PhIRDA proposed special requirements for processing clinical data in case trial protocols are disrupted and conducting on-site inspections remotely due to travel restrictions.
One proposal, for low-risk products, is to grant conditional approvals with strengthened postmarketing surveillance.
Another proposal is to put in place a special consultation channel for drug candidates designed to treat critical indications to enter clinical trials without interruptions.
To minimize the impacts on clinical trials, PhIRDA called on physicians and patients to use remote communication tools to replace on-site visits, urged good clinical practice (GCP) organizations and ethical review committees to hold meetings remotely, and recommended authorities give priority to clinical research organizations (CROs) to resume operations, especially in areas with lower health risks.
Disruptions in logistics and supply chains have also resulted in financial difficulties for some biotech companies, especially those with poor cash flows.
To sustain the long-term development of the pharma industry, PhIRDA urged the Chinese government to halt its centralized procurement program to relieve the burden on companies. The program requires companies to negotiate prices for their drugs with the government to win contracts.
Policy overhaul and reflection
The COVID-19 outbreak has been a wake-up call for China to improve its health care policies and establish a system of emergency use authorizations for future crises.
“This outbreak has prompted the Chinese government to further improve its national stockpile system for drugs and medical devices,” Song said.
He said he believes that a strategic national stockpile system is of utmost importance to respond to public health emergencies like COVID-19, but creating such a stockpile will require efforts from both the pharmaceutical industry and government.
“While the companies can develop drugs and keep sufficient stock to provide them when needed, the government needs to bear the costs of stockpiling these products,” Song said.
With most health care resources going to fight the coronavirus, patients who are not infected with the virus have gone unattended.
Among the suggestions to regulators this month, PhIRDA said that in the long term, the government should consider cancer drugs as essential supplies and stockpile them to ensure sufficient inventory for cancer patients in affected areas.
The association has also called for emergency use authorization. China currently lacks a system that would be similar to the one currently in place in the U.S.
In late February, PhIRDA submitted a detailed proposal to authorities on establishing emergency use authorization through legislation and the introduction of special procedures for drug approvals.
The proposal specified the responsibilities of different agencies. The state would be responsible for declaring a national emergency, while it would be up to the National Medical Products Administration (NMPA) for activating the emergency use authorization to approve drugs that are needed urgently. The National Healthcare Security Administration would provide temporary reimbursement for those drugs.
China was the first country to experience an outbreak of COVID-19 and has faced criticism for delays in announcing a public health emergency back in January. Song said there is a policy in place to track outbreaks and declare emergencies but implementation is key.
“After the SARS outbreak, China promulgated the Law on the Prevention and Treatment of Infectious Diseases, which strictly requires the local CDCs to report cases to the national CDC,” Song said, adding that local authorities had failed to comply with that requirement this time.
“China has a lot to ponder in terms of implementing its policies,” he said. “We need to specify the responsibilities of the central and local governments, and even the authority of the CDC and government agencies, when it comes to announcing a public health emergency.”
Collaboration and innovation
While PhIRDA focuses on solving problems at home by advocating policies, Song said he believes global efforts and a strong will to innovate will be the ultimate solutions to COVID-19 and future outbreaks.
“Diseases do not need a visa or passport to travel. After an outbreak takes place in a country, if the global community does not raise its guard, the outbreak will eventually hit everybody,” Song warned.
He called for a global health care system, in which pharmaceutical companies and research institutes around the world can make joint efforts. The U.S. and China, the world’s two biggest economies, should take up more responsibilities to address a global public health emergency.
“Protectionism only restricts interactions and exchanges,” he cautioned. “Collaboration, rather than protectionism, is what we need to fight a common enemy.”
Song’s appeal came at a time when the World Health Organization proposed a master protocol for companies and institutions around the world that aim to test therapeutics against SARS-CoV-2 as part of its COVID-19 R&D Blueprint.
Constant dedication to innovation also has a role. Song said governments should step up input in basic research for anticoagulant and antiviral drugs.
“Governments should encourage pharma companies to innovate and conduct R&D,” Song said. “When there is a sudden virus outbreak, we will then have drugs that come in handy at the initial stage and be able to mobilize our R&D and manufacturing capabilities to address the situation at a later stage.”