Red Tape Challenge – medicines regulations in the spotlight

Red Tape Challenge – medicines regulations in the spotlight

Date: 9 March 2012
Time: 14:00
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The Medicines and Healthcare products Regulatory Agency (MHRA) is asking for views on the regulations that govern its work.

For the next five weeks, through the Cabinet Office Red Tape Challenge website, the MHRA is inviting the public and businesses to suggest which existing regulations should be kept and which should be simplified or scrapped altogether.

The Government's Red Tape Challenge aims to cut unnecessary and over burdensome regulations.

Good regulation plays a vital role in protecting the public and employees. However, the Red Tape Challenge asks whether existing regulations are really providing the protection that is intended, or are they unnecessary or overcomplicated and need to be improved or go altogether. Even where regulations are EU derived, as many of theses regulations are, there may still be scope to improve implementation and enable greater efficiency.

There are more than 250 separate regulations that impact on the work of the MHRA. For the Red Tape Challenge they are broken down into eight themes – medicines, clinical trials, Good Laboratory Practice (GLP), traditional herbal medicines, homeopathic medicines, blood, fees and pharmacy.

Whilst the consultation is aimed at those that the regulations directly apply to, everybody can join the debate and send their comments through the Red Tape Challenge website (external link).

With the help of comments made to the website, MHRA will go through and decide what action it needs to take on each and every regulation. Their proposals are then reviewed by a ministerial 'Star Chamber' who again meticulously go through the regulations with the presumption that they will go unless they can be strongly justified. The process will take about three months.

Professor Sir Kent Woods, Chief Executive of the MHRA said "regulations are hugely important to the work that we do but we want to ensure we can carry out our work in the least burdensome way possible whilst ensuring patients are protected. The Red Tape Challenge is an opportunity to seek views on these regulations to ensure we can work in the most efficient way possible whilst continuing to keep patient safety at the heart of everything that we do."

Health Minister Simon Burns said:

"We are committed to removing excessive burdens and reducing bureaucracy where we can, whilst making sure that patient safety is never compromised.

"This Challenge will give those working in industry and clinicians a vital opportunity to let us know how we can improve the way we regulate or how we can do things differently, whilst ensuring the public is protected.

"We will use the feedback they give us to plan how to get rid of requirements that are no longer needed, freeing industry from unnecessary red tape and giving health professionals more time to care for patients."

As there is a separate government review into the regulation of medical devices, we will await the conclusions of this before medical devices are put through the Red Tape Challenge process later this year.

Notes to Editor

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
The Red Tape Challenge was launched by the Prime Minister on 7 April 2011. It gives business and the public the chance to have their say on some of the more than 10,000 regulations that affect their everyday lives.
The Red Tape Challenge 'Medicines' theme starts on 9 March and run until 12 April 2012.
The website is available - Red Tape Challenge (external link).
5. The Challenge process does not include legislation or regulations falling within the responsibilities of the devolved administrations.