A Fairer Framework for Drug Approvals

Words by Cheyenne Eugene

The pandemic unlocked new levels of speed within the drug development and approval process. We explore the mechanisms that were employed during the global crisis and how standardisation can offer solutions that ensure medication and technologies keep reaching patients faster than ever.

The body’s homeostatic adjustments and the laws that rule our society are both forms of regulation that uphold our personal wellbeing. Regulation exists to keep us safe, however a paradox came into play during the COVID-19 pandemic. We urgently needed vaccines to protect ourselves and curb the spread of disease, but we also needed rigorous regulation to ensure that these fast-developing vaccines were safe. For the pharmaceutical industry, there was a crucial balance to strike.

Vaccine development is a long and complex process, often taking up to 10-15 years, whereas the vaccines developed for COVID-19 were formulated, tested, and distributed in under a year. So, what components of the regulatory process were re-engineered during the pandemic to ensure speedy but safe vaccine development?

Emergency use authorisations (EUAs) placed a firm foot on the gas to get vaccines into the public health sphere. Penelope Ward, Company Director, PWG Consulting (Biopharma) Ltd, explains: “Developers were able to file their applications for marketing approval in a ‘rolling’ fashion, rather than waiting for all information to be available before compiling the data for submission.” She continues: “The rolling reviews enabled an EUA, a regulatory process that has existed internationally for many years but has rarely been needed.” An EUA enables specific use of a medicine during a health emergency with efficacy and safety reviews ongoing during use. There are certain restrictions, such as on advertising, but, ultimately, the product can be distributed by healthcare systems to the public. Of course, for approvals to be carried out faster, a significant amount of ‘people power’ is required. Ward expands: “Regulatory authorities formed emergency action groups within their own environments to ensure a group of dedicated staff was made available to companies developing drugs and vaccines. This facilitated rolling reviews and advice on development plans, protocols, and results from preclinical studies to enable regulatory approval to be more rapidly obtained.” She acknowledges that having dedicated staff who work on fast-track assessments is helpful, but might not be a realistic long-term solution given the number of drugs in development at any one time.

Manufacturing capabilities have long been an industry hurdle in terms of drug development and distribution, but some companies and countries are fortunate enough to have huge manufacturing capacities. However, even for some of them, the regulatory process can introduce delays and difficulties. Dr Jerome Kim, Director General, International Vaccine Institute details this. Speaking on the EMG GOLD Podcast, Kim says: “Potential delays apply more to companies that produce vaccines [outside of] what we would call a ‘stringent regulatory setting’.” Stringent regulatory authorities are those considered world-class, including the FDA in the US, the European Medicines Agency in Europe, and the Therapeutic Goods Administration in Australia. Companies developing vaccines in these areas can secure rapid review by their regulatory agency, and then by the WHO, which subsequently issues an EUA quickly.

But what about companies existing outside of these ‘stringent regulatory’ zones? Kim continues: “The companies that had problems were those located in countries with what we call ‘functional regulatory authorities’.” These include the Ministry of Food and Drug Safety in Korea, the National Medical Products Administration in China, and the Drugs Controller General of India. “They are recognised by the WHO as doing a complete job, but they do not meet the criteria for the most stringent regulatory authorities.” Kim explains that pharma companies in areas with ‘functional regulatory authorities’ essentially have a longer race to run: “The company collects all the information on safety and efficacy, [submits it to their regulatory body] then they have to give that information to the WHO, which then does another full review, and often there are questions.” This lack of ‘stringent’ regulatory status essentially leaves the process vulnerable to delays.

Kim notes: “It was not necessarily that the system did not work, it was just that the WHO was trying to ensure that these products from non-stringent authorities [met] the requirements necessary for [an EUA].” He recognises that Indian, Chinese, and South Korean, as well as many other pharma companies all have the capacity to manufacture significant quantities of vaccines that meet the WHO’s standards. “We just need to be better at integrating the timelines for their regulatory review, final review, and approval by the WHO. That is where a bit more efficiency could be used,” he says.

Many of the regulatory measures taken during the COVID-19 crisis will not become the status quo but standardising regulatory processes can offer relief: “Collaboration between manufacturers and regulators with a view of creating a single set of manufacturing standards internationally might be helpful,” states Ward. Uniformity means streamlined processes: “We have to remember that every step that we accomplish is going to be followed by another step,” says Kim. “It was the transitions that hurt us.” Regulation is designed to keep us safe, but it should not mean that we sacrifice efficiency. Before the next pandemic arises, the pharma industry must focus its efforts on rebalancing these vital scales to ensure equity and agility within the drug approval landscape.