The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level.
“Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been taken, this is against a backdrop of adverse incident reporting, which has more than doubled since 2007,” MHRA said.
MHRA makes clear that it’s working “in a financially challenging context,” particularly as Britain decides whether to leave the European Union and as the regulatory environment “has become more competitive and increasingly global.”
On the pharmaceutical side, one of the major changes MHRA has seen recently in terms of lost funding is linked to the EU’s pharmacovigilance system, as fees are now set at the EU level, which means reductions in regulatory income. But despite the lack of funding, MHRA is still looking to take a leading role at the EU and international level.
“Pending the outcome of the EU referendum, the UK Presidency of the Council of the EU in 2017 will allow the Agency to influence the European regulatory agenda more strongly and to further its priority of combining the safeguarding of patient safety with increasing the global competitiveness of the European life sciences sector,” MHRA added.
The agency also says it will continue its work with other EU regulators, including the Heads of Medicines Agencies Network and the European Medicines Agency (EMA) and “play a leading role in scientific committees, European Council working groups and Commission led expert committees,” as well as to lead parts of the International Coalition of Medicines Regulatory Authorities (ICMRA), International Medical Device Regulators Forum and the Competent Authorities for Medical Devices (CAMD) and through bilateral contacts with other international regulators, including India’s Central Drugs Standard Control Organization (CDSCO).
More specifically, MHRA said it will lead the work in ICMRA to “define practical steps for greater mutual reliance between global regulators on shared inspection data” and support ICMRA to build on collaborations to secure safe supply chains, strengthen vigilance and improve incident management.
The agency is also looking to complete the necessary steps to confirm a program of EU joint action on medical device market surveillance, among other actions with its partners.
In addition, MHRA is looking to promote and influence international partnerships in the enforcement, inspection and pharmacopoeia arenas (including work with China, India, US, Europe) through interactions at symposia, meetings and conferences.
Key investments by MHRA will be made in:
- Digital technologies to deliver cost-effective and smart services for the benefit of users (£6m);
- Further developing devices’ efficiencies and facilitating the move to a new funding regime (£1m);
- Replacing obsolete equipment at MHRA and British Pharmacopoeia laboratories (£0.4m)
“In some key areas of MHRA business – including medical devices and in vitro diagnostic devices and clinical trials – EU regulation is either being, or has recently been, revised with the aim of creating a more effective and harmonised EU framework. MHRA must ensure effective and efficient implementation of EU legislation – in line with UK regulatory principles – if we are to meet our objectives of protecting and improving the health of the public, while also allowing UK industry to innovate,” MHRA said.
In addition, the agency will look to strengthen mechanisms for data sharing and analysis with UK, EU and international partners to support early detection of emerging safety issues for drugs and devices. Implementation of the safety features and unique identifier aspects of the Falsified Medicines Directive will also be a driver of MHRA’s work, as will a new UK communications campaign to increase public awareness of the dangers of purchasing medicines and medical products outside the legitimate supply chain.
Medicines and Healthcare products Regulatory Agency Business Plan 2016-17