New review seeks pharmaceutical sector’s views on enforcement of regulation
Review invites pharmaceutical sector to tell the government how well national regulators and local authorities enforce rules
A review launched today invites pharmaceutical manufacturers and producers to tell the government how well national regulators and local authorities enforce rules governing the sector.
Through the Focus on Enforcement review, ministers 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.
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 Association of the British Pharmaceutical Industry (ABPI) said:
We welcome the Focus on Enforcement review announced by the Better Regulation Executive into regulatory practices in the pharmaceutical sector. 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 said:
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 manufacturers and producers of pharmaceutical products in meeting their obligations, 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 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 review of compliance and enforcement activity in the pharmaceuticals manufacturing and production sector is open for comment from today at http://discuss.bis.gov.uk/focusonenforcement/
The evidence-gathering phase of the review will close in September; a response from regulators will follow.
Notes to editors
1.The government is committed both to reducing overall regulatory burdens on business, and to ensuring that necessary regulations are enforced effectively, imposing minimum bureaucracy on compliant businesses. The government also plans to introduce a ‘growth duty’, which will impose a legal requirement on all non-economic regulators to consider the impact of their work on the growth prospects of the firms and sectors they serve.
2.Pharmaceutical manufacturing and production is the 10th Focus on Enforcement review theme to be launched. Other reviews have engaged with sectors including coastal projects and investments, pubs, adult care homes, childcare, chemicals, small food manufacturing, fire safety and volunteer events. There has also been a review of regulatory appeals mechanisms.
3.The Focus on Enforcement website allows comments to be posted ‘on the record’ or anonymously.
4.Join the conversation on Twitter using the #focusenforce hashtag and follow us @JoKaczmarekBIS
5.The scope of the Review of compliance and enforcement activity in the pharmaceuticals manufacturing and production sector is as follows:
- regulatory activity by national regulators and local authorities that affect the day-to-day operations of manufacturers and producers of pharmaceutical products
- the impact of the overall regulatory regime on both large and small manufacturers
- the whole of the manufacturing and production process, including applying for relevant licences and the development of products
The scope of the review does not include:
- regulations themselves
- issues related to the distribution and sale of pharmaceutical products (but not issues relating to contracts to manufacture pharmaceutical goods which are in scope)
- issues related to the manufacturing process for dietary supplements will not be included in this review, except where they become subject to the regime which applies for pharmaceutical production and / or manufacturing
- other regulatory activity that is not particular to businesses in the pharmaceutical manufacturing / production industry (e.g. employment law, company law, planning applications)
6.Regulatory Activity within the context of the review includes:
- provision of advice on compliance with the law
- inspections visits and assessments of premises and equipment
- any requirements to make formal applications, or provide specific information, for example, to obtain necessary permits and licenses
- any requirements on businesses and their staff to attend courses or obtain particular qualifications
- formal enforcement proceedings taken against individuals or organisations in the event of failure to comply with regulations
7.Focus on Enforcement reviews focus on the way regulation is delivered and compliance is achieved – whether through inspections, advice or enforcement – not on the regulations themselves. (A separate initiative – Red Tape Challenge – invites comments and ideas on what regulations should stay, be improved, or be scrapped altogether). Each Focus on Enforcement review starts with a 6 to 8 week evidence-gathering phase.
8.The government’s economic policy objective is to achieve ‘strong, sustainable and balanced growth that is more evenly shared across the country and between industries’. It set four ambitions in the ‘Plan for Growth’, published at Budget 2011:
- to create the most competitive tax system in the G20
- to make the UK the best place in Europe to start, finance and grow a business
- to encourage investment and exports as a route to a more balanced economy
- to create a more educated workforce that is the most flexible in Europe
Work is underway across government to achieve these ambitions, including progress on more than 250 measures as part of the Growth Review. Developing an Industrial Strategy gives new impetus to this work by providing businesses, investors and the public with more clarity about the long-term direction in which the government wants the economy to travel.