Pharma views sought on UK regulation
pharmafile | July 9, 2013 | News story | Research and Development, Sales and Marketing | ABPI, MHRA, pharma
A new review is inviting pharma to tell the UK government just how well national regulators and local authorities enforce rules.
Through the ‘Focus on Enforcement’ review, ministers says they want to hear about any unnecessary burdens that are being placed on businesses, any duplication and inconsistencies between regulatory bodies and to find out whether companies are receiving the clear guidance they need to comply with the law.
Firms are also invited to identify areas of good enforcement practice which could be replicated elsewhere. The main thrust of the review will focus around the UK’s local regulator the MHRA.
Business minister Michael Fallon said: “The UK pharmaceutical industry is a vital player in an increasingly competitive international market. We must maximise its potential to attract investment, innovate and create jobs, while maintaining world-class quality and safety standards.
“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.”
Stephen Whitehead, chief executive of the ABPI, said he welcomed the review, adding that the body 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”.
The review will look at issues faced by manufacturers and producers of pharma products in meeting their obligations, including:
- how and where they access information about their legal obligations
- how they prefer to access advice and guidance
- 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 them.
The review is not set up, however, to look at the regulations themselves, or issues related to the distribution and sale of pharma products.
A separate initiative called the ‘Red Tape Challenge’ – launched earlier this year – invites comments and ideas on what regulations should stay, be improved, or be scrapped altogether.
These both form part of the government’s growth strategy which aims to help bigger industries like pharma work more efficiently in the country in order to attract more firms, and help the economy.
The review of compliance and enforcement activity in the pharmaceuticals manufacturing and production sector is open for comment here.
The government is also keen to widen its digital offering, and says pharma can join the conversation on Twitter using the #focusenforce hashtag and follow @JoKaczmarekBIS at the Business department.
The review will close in September and a response from regulators will is expected shortly after.
Ben Adams
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