Regulatory flexibility: embracing agility over protectionism in the pharmaceutical industry
The last couple of years have taught the public terms such as rate of contagion, exponential growth, and percentage of effectiveness. It has also taught us how time is the most critical element that can affect each of these indicators. This is not new for pharmaceutical companies, who are used to navigating the slow maze of red tape that comes with releasing a new product, developing a generic, or changing an existing formula.
In the case of the United States, many of the R&D delays during the early days of the pandemic were caused by the processes required by every of the regulatory bodies involved. Although the FDA, EMA, and local medical agencies were doing an excellent job, the crisis proved how their standard processes can be too slow to respond in times of urgency.
A 2020 public consultation held by the European Commission found that 87% of respondents were concerned about drug shortages, and that most of them wanted to maintain the regulatory flexibility created by COVID-19. In addition, pharmaceutical stakeholders expressed their support for evidence-based actions, mapping supply chain vulnerabilities and promoting supplier diversification.
Jason Grenfell-Gardner, CEO and founder of the J. Molner Company, states that regulatory flexibility is needed because it could also help in other non-pandemic scenarios:
“If a factory in China that produces a significant amount of a certain API burns down or is shut down by the national government for any reason, there should be a way to fast-track changes to existing drugs and approve new applications for generic drugs and supplement existing drug approvals,” he explains.
The lack of regulatory flexibility also affects companies working in drug development for diseases that are less known or understood. Dr. Cartier Esham, Chief Scientific Officer and EVP of Emerging Companies at the Biotechnology Innovation Organization (BIO), recently explained how unequal the regulatory process can be to the U.S. House Energy and Commerce Subcommittee on Health:
“In 2021, we counted 653 clinical development programs for medicines to treat neurological diseases, 43% of which are for neurodegenerative diseases. By comparison, there are 2798 oncology clinical development programs. There have only been a total of 39 FDA approvals for neurological treatments in the past decade compared to 123 for oncology,” she said.
The ideal pharmaceutical industry would operate in an open system with appropriate redundancies and regulatory swiftness rather than a system geared towards healthcare protectionism. These drives to repatriate manufacturing and other protectionist measures ignore the reality that regulatory, environmental, and supply chain issues can happen in any jurisdiction - even our own backyard. Rather, the key to a stronger supply chain is agility through a science-based regulatory framework that embraces the likelihood of disruption. Pharmaceutical advocates and regulatory bodies have already started to push for more flexibility.
The FDA has eliminated some outdated biologics requirements, allowing US drug companies to employ new technologies and testing tools. For example, Eli Lilly adopted Amazon's Elastic Compute Cloud (EC2) platform to conduct simulation models within hours, which otherwise would have taken weeks using traditional models.
In June 2021, the European Union identified five COVID-19 therapeutics that it will prioritize with the hope to authorize three by October.
“Our goal is clear, we aim to identify more front-runner candidates under development and authorise at least three new therapeutics by the end of the year. This is the European Health Union in action,” said Stella Kyriakides, Commissioner for Health and Food Safety.
In addition to this fast-tracking, the EU will hold a matchmaking event to facilitate industry partnerships and will jumpstart other actions to identify and address supply chain roadblocks and plan for expedited production of COVID-19 therapeutics.
In a preliminary assessment for a new EU pharmaceutical strategy, the European Commission also found that a more open system would aid the emergence of scientific developments and new technologies, which would make the European Union more attractive for pharmaceutical investors, marketers of innovative products and even smaller players:
“SMEs stand to gain most from a simplified regulatory system and flexibilities related to modern developments. Start-ups and small companies are often responsible for basic R&D and are expected to benefit from a simpler regulatory environment,” the Commission stated.
Having more regulatory flexibility would allow earlier competition between pharmaceutical products. A simplified regulatory approval could promote a faster production of generics, thus decreasing the therapeuticals expenses for national health systems and private households. This positive effect could be further reinforced with simplified pharmaceutical legislation and a reduction on the existing administrative workload for both companies and regulators.
With a more flexible system that promotes competition, the industry could secure its supply availability and provide a stable flow of critical medicines that is ready to deal with the next big crisis. This would not only future-proof the pharmaceutical ecosystem, but also have positive societal effects in terms of health, employment opportunities, and options for patients and their caregivers.