The Medicines and Healthcare products Regulatory Agency (MHRA) has announced its aim to be “a leading regulator on the world stage in supporting science and research” as part of its new five-year Corporate Plan.
The Plan, which sets out the agency’s strategic direction for 2013-18 and has been developed using responses from stakeholders following a public consultation launched last December, is for an enlarged agency, with the transfer this month of the National Institute of Biological Standards and Control (NIBSC) to the MHRA from the Health Protection Agency (HPA). This joins the Clinical Practice Research Datalink (CRPD), which was launched in April 2012.
In his foreword to the Plan, MHRA chair Professor Sir Gordon Duff says that it “sets out our ambition to seize the opportunities from our enlarged role to build a world-class organisation in all aspects of the work we do.”
“We have an unusual, if not unique, set of activities encompassing regulation, standards, research and information; we work at a critical juncture between science, industry and clinical practice,” he writes, adding that the opportunities and challenges which the Agency has identified for the next five years start with the changing expectation from society about what it wants from the regulator.
“As always, the regulator must continue carefully to assess the relative benefits and risks of products and determine which enter, and remain on, the market,” he writes.
But there is also an increasing role for regulation to help inform and influence individual clinical decisions, while “acting in the best interests of individual and public health also means supporting innovation in the development of useful new medicines and devices. We are committed to this,” Sir Gordon says.
Medicines and medical devices have different regulatory regimes but some common challenges, which the Agency says it also faces. These include:
– getting right the balance of regulation before and after entry to the market, especially risk management in support of innovation;
– building a controlled space for learning about the performance of medicines and devices – especially those that are innovative and may be higher-risk – over the early lifecycle;
– ensuring that quality is maintained as more manufacturers around the world enter the market, especially in the area of biologicals;
– working across the European Union (EU) and internationally, especially on licensing, vigilance and inspection;
– engaging with healthcare professionals to influence clinical practice and improve information on the performance of medicines and devices (ie, their safety and effectiveness in actual clinical use);
– ensuring stakeholder understanding of what the regulator can and cannot do, enabling more informed decisions by clinicians, patients and the public;
– working with other regulators, including making an effective and clearly-defined contribution to the work of bodies responsible for health technology assessment (HTA);
– reducing the number of counterfeit medicines and devices in the supply chain;
– increasing transparency in how the Agency operates;
– promoting a consistent, proportionate approach to regulation, reducing burdens where it is safe and cost-effective to do so; and
– running an efficient business, ensuring sustainable funding and resourcing of regulatory activity and demonstrating value for money.
While the Agency does not have, or envisage having, a role in evaluating cost-effectiveness, the interface between the Agency and HTA bodies will increase in scope and importance, it says. “Data from the CPRD has the potential to inform the work of HTA bodes as well as our own regulatory work.”
Here, its objectives to 2018 will be to: – make best use of data available through CPRD and other sources, to provide more information about the performance of medicines and devices (benefit/risk) to influence clinical practice; – building partnerships to ensure that information about the performance of medicines and devices influences clinical practice in the interests of patients; and – enhance understanding of the role regulation should play as part of wider public health and healthcare systems.
And with the aim of bringing innovation safely to market, the MHRA’s objectives over the next five years will be to: – influence thinking and regulation in the EU and globally to achieve a convergence of standards – ensuring effective EU laws and professing international thinking about global governance; – explore, in the context of government interest in adaptive licensing, “how we might redraw the boundary between pre- and post-market entry regulation to enable earlier patient access to beneficial innovative products, while managing associated risks;” and – realise the full benefits of NIBSC and CPRD to support innovation and contribute to the government’s life sciences and growth agendas.
