Review launched into pharmaceutical regulation

Posted on 9 Jul 2013

The Government has launched a review inviting pharmaceutical manufacturers and producers to comment on enforcement of rules governing the sector.

The Focus on Enforcement review will look at how well national regulators and local authorities apply regulation and ways the system can be improved.

Reviewers are looking for comment on inconsistencies on compliance guidance as well as examples good enforcement practice that can be adapted to other sectors.

Business minister Michael Fallon sees the review as part of maximising the pharmaceutical industry’s potential.

“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.”

The review has a list of specific areas as guidance to the questions  that the Government is looking to get feedback on.

  • 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)

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 run until Monday 2nd September, with a review to be published after the information has been collected. The review is open for comment.