New review seeks UK pharma industry’s views on enforcement of regulation
Government is asking whether any unnecessary burdens are being placed on businesses
The UK government is inviting pharmaceutical manufacturers to tell it how well national regulators and local authorities enforce rules governing the sector in a review launched today (9 July).
Through the Focus on Enforcement review, the government wants to hear about any unnecessary burdens that are being placed on businesses, any duplication and inconsistencies between regulatory bodies and to find out whether pharma businesses are receiving the guidance they need to comply with the law.
Pharma manufacturers are also invited to identify areas of good enforcement practice that could be replicated elsewhere.
Business Minister Michael Fallon said: ‘I want firms to tell us how we can improve the environment in which they work. We want to make sure regulation is proportionately and intelligently applied to facilitate their contribution to our economy.’
I want firms to tell us how we can improve the environment in which they work
Stephen Whitehead, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), welcomed the review and said: ‘The MHRA has been at the forefront of developing risk based approaches to regulatory inspections, and the ABPI looks forward to participating in the review to establish if there are ways in which regulatory processes in this sector can be enhanced to the benefit of all stakeholders.’
Nigel Goode, Senior Director of Aptuit, a pharmaceutical services company based in Oxfordshire added: ‘Good regulatory oversight must be designed to support effective business and responsible corporate governance. Creating an open dialogue between industry and those charged with promulgating, interpreting and overseeing regulations is a critical part of assuring that we establish consistency and simplicity to allow business and government to pull in the same direction.’
The review will look at issues faced by pharmaceutical manufacturers, including:
- How and where they access information about their legal obligations.
- How they prefer to access advice and guidance.
- The interaction between different regulators and the impact of compliance activities carried out by different public authorities.
- Any ‘knock-on effects’ arising from compliance with legislation – for example, where action to meet one set of regulations leads to conflict with another set of regulations.
- The consistency of enforcement decisions and the ease of appealing against them.
- Whether third parties are encouraging companies to undertake unnecessary compliance activity (e.g. where regulation does not actually require something to be done, but companies are led to believe it does).
The evidence-gathering phase of the review will close in September; a response from regulators will follow.