Wednesday, 14 October 2015

Do regulators have a role in pharmaceutical innovation?

The prime drug development regions of the world remain the US, Europe and Japan and to a large extent, these countries have harmonised many of the regulatory requirements. For example, ICH-GCP is now considered as the global standard for clinical trials and has become a legal requirement in many countries. As well as standardising and harmonising regulations, US, European and Japanese regulators have also publicly acknowledged that part of their mission is to support medical innovation.

All three regulatory agencies believe that medical innovation can be stimulated through the discipline of regulatory science and are increasing their collaboration with each other. Regulatory science involves the use of improved regulatory tools, such as new methods, models or technologies, to overcome barriers in translating research into real products so that new medicines can be made available for society. This requires collaboration between different specialist groups within the regulatory agencies and between agencies so that appropriate expertise can be harnessed for different regulatory scenarios. It also involves better communication so that stakeholders understand how a decision was reached and its implications for other drugs in development.

One area in which this regulatory input has been apparent has been the introduction of orphan drug legislation to stimulate drug development for rare diseases. Previously, due to the low potential for financial return on R&D investment there had been little interest from pharmaceutical companies in developing products for this area. This regulatory framework, which has been adopted in the US, Japan, EU and other regions, has transformed R&D for rare diseases, and many patients have benefited. Although the details and benefits of orphan drug legislation vary between regions, there is general consensus that many orphan drugs would not have been developed without appropriate legislation.

Initiatives to improve the regulatory framework and stimulate innovation are continuing, with the major regulatory agencies actively collaborating with industry, government, academia and other stakeholders. In March 2004, alarmed by the decline in the number of innovative medical products being submitted for approval, the FDA created The Critical Path Initiative. The Initiative represented a national US strategy to drive innovation in the scientific processes through which FDA-regulated medical products were developed, evaluated, and manufactured. In 2003, the EMA set up the Innovation Task Force (ITF) and brought together relevant competencies from different parts of the Agency. The Agency also launched a consultation process with industry and other stakeholders concerning bottlenecks and redundant or irrelevant requirements perceived as holding back innovation.

While the regulators’ primary role is to ensure patient safety, it is clear that they want to be seen as playing an active role in promoting innovation. New collaborative initiatives with stakeholders are emerging and there are a number of opportunities for more companies to get involved.

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