UK Consults on Early Medicines Access - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

UK Consults on Early Medicines Access


ePT--the Electronic Newsletter of Pharmaceutical Technology

UK Consults on Early Access to Medicines

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials. The consultation will be open until Oct. 5, 2012.

The scheme is expected to apply to medicines for life-threatening, debilitating, or chronic conditions that are at the end of Phase III trials or, in certain cases, at the end of Phase II. Research conducted by MHRA has shown broad support for such a scheme, particularly for patients suffering from life-threatening illnesses.

If implemented, MHRA would review medicines that companies want to make available under the scheme and provide a scientific opinion on the risks and benefits. This information would help the country’s National Health Service in deciding whether the medicine should be available early.

“We have launched this consultation because we are committed to ensuring that where pharmaceutical companies want to make their new medicines available under this scheme, clinicians treating patients have access to robust scientific information to help them make appropriate treatment decisions,” explained Kent Woods, chief executive of MHRA, in a statement.

In its research, MHRA emphasises that patients will need to be fully aware of the risks of taking unlicensed medicines. There were also mixed views on whether early access to medicines should be given to patients with debilitating or chronic conditions, such as rheumatoid arthritis or diseases that may cause blindness.

After receiving all feedback, MHRA will aim to make a decision on implementing the scheme by the end of 2012.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here