The new, expanded Medicines and Healthcare products Regulatory Agency (MHRA) is set to become a global player, but industry has urged it "not to forget its UK work" or to lose its informal scientific advice focus.<\/p>
In April, the National Institute for Biological Standards and Control (NIBSC) transferred to the MHRA from the Health Protection Agency (HPA), joining the Clinical Practice Research Datalink (CPRD) which was launched in April 2012. These developments represent a great opportunity for the MHRA to become a major international regulatory agency with expertise in every aspect of pharmaceutical regulation, especially in biological drugs, which are beginning to dominate the market and where its expertise is unrivalled, Dr Stephen Inglis, director of the NIBSC, told a joint MHRA/BioIndustry Association (BIA) meeting in London this week.
Nick Sykes, director of European regulatory policy at Pfizer, said the industry welcomes the additional expertise in biological drugs, including biosimilars, vaccines and regenerative medicine which NIBSC brings to the MHRA, and the international opportunities which both this and the work of the CPRD present, at European Union (EU) and global level, to support medicines innovation.
But the Agency must balance this global involvement with its work for products aimed at purely national markets, he added. Such products account for 45% of Pfizer's UK portfolio and 16% of its revenues.
In March, the Agency launched a new Innovation Office, whose main aim is to promote early dialogue between innovators and the MHRA. In response to questions, Dr Inglis stressed that there is no intention that the office should block the Agency's other, pre-existing channels of formal and informal advice to industry.
The Agency is keen to work with industry to support innovation, especially in terms of getting the benefit:risk balance right. It now offers strengthened support for the industry - and with a single front door, he said.
But Dr Sykes again sounded a note of caution. Currently, he said, the NIBSC offers the industry "rich, scientific, information" discussions, on a scientist-to-scientist basis, with flexibility in the content of briefing packages and in the timing of meetings - these can be a short notice - and there is no fee.
All of this is very different from MHRA scientific advice meetings, he said, and urged the Agency not to "layer bureaucracy" over the process but to keep things as they are. The industry is keen to engage with how NIBSC activities will be integrated with those of the MHRA, he told the Agency.
Dr Sykes also called on the MHRA to work with the NHS and the National Institute for Health and Care Excellence (NICE) to ensure greater understanding of quality, safety and efficacy issues and the risk:benefit balance of medicines. And the focus of these discussions has to be on science-based decisions, not budgetary considerations, he emphasised.
Greater understanding by regulators and payers of the new advances in drug development are not enough to win a value-for-money proposition for new products – the benefit: risk profile will do this, said Dr Will Deere, international chief medical officer and senior vice president, global development, at Amgen. Dr Deere called for harmonisation between the regulatory review process and an understanding of the fundamentals of health technology assessment (HTA).
Asked if Amgen has had discussions with payers aimed at educating them about the challenges of drug development, Dr Deere said the firm has had such conversations with the MHRA and the National Institute for Health and Care Excellence (NICE). Their perspectives are of course different, "but it is necessary for us to have a comprehensive strategy," he said.
The tough one, he added, is how companies can get a consolidated, European Union (EU)-wide view of what regulators and payers want.