 The scheme collects information on adverse drug reactions |
A review is to be carried out into the NHS scheme for reporting adverse drug reactions. The review into the "yellow card scheme" will examine if people, including pharmaceutical companies, should have access to the data collected under the scheme.
It will be headed by Dr Jeremy Metters, England's former deputy chief medical officer.
He will examine the ethical, logistical and financial implications of allowing people to have access to reports filed under the scheme.
Voluntary reporting
Doctors and all other NHS staff are encouraged to report serious side effects of drugs, while the pharmaceutical industry is legally obliged to do so.
Patients can also report adverse reactions through the telephone helpline NHS Direct in some regions of England.
All of this information is collected by the Medicines and Healthcare products Regulatory Agency. It examines the data and decides whether or not any action needs to be taken, such as advising doctors against prescribing a particular drug or restricting its use to only certain groups.
All of the reports are confidential and the information is not made available to any third parties.
However, in recent months the MHRA has seen a sharp increase in the number of people seeking access to the data.
Many of the reports are very specific and could help the pharmaceutical industry to develop better drugs.
Dr Metters said his review will examine whether private companies should be given access to the data.
"There are issues around the confidence of health professionals in the confidentiality of the scheme and how the data could be used to unlock the potential for so called 'designer medicines'.
"Ethical and financial questions are also raised as to the use of an important public health tool for commercial gain."
Professor Alasdair Breckenridge, chairman of the MHRA, said: "The yellow card scheme has been the cornerstone of monitoring drug safety for nearly 40 years and has an excellent track record in protecting public health.
"The data generated by this scheme is very important and it is right that we take a careful and important look at how we safeguard its use in the future."
Health Minister Lord Warner said: "After almost 40 successful years, our aim is to maintain the capacity of the scheme to deliver public health benefits and prevent potential abuse of this important data in the future.
"It is essential to determine in what form this important data should be made available."
The review is expected to be completed before the end of the year.
Any proposals to change the current rules are expected to be published for consultation before an action is taken.