The National Audit Office’s review of the Medicines Control Agency has been welcomed by the Association of the British Pharmaceutical Industry (ABPI), which joins the NAO in recognising the MCA’s international standing for scientific and regulatory expertise.
And the ABPI also believes that the MCA - which will become the Medicines and Healthcare Products Regulatory Agency (MHRA) in April - should continue to have a prominent role as a leader in the development of European regulation.
“This report takes a long and careful look at the activities of the MCA, and its analysis is to be praised,” said Dr Trevor Jones, Director General of the ABPI. “The MCA is one of the best and most efficient regulatory agencies in the world, and it is a real asset to the pharmaceutical industry, the NHS and patients.
“However, the ABPI does accept that the MCA’s profile could be higher with prescribers, and the report contains sensible and constructive suggestions on how this could be improved.”
The NAO report makes criticisms of the information provided about medicines - both in the form of patient information leaflets and labelling.
The pharmaceutical industry also believes that patient information leaflets could be more patient-friendly, but the problem centres around tight European regulations on what information has to be included and excluded, as well as how it can be presented.
“Industry has been in the vanguard to change such laws within Europe so that patients can understand both leaflets and labels better,” said Dr Jones.
“At the same time, the ABPI firmly believes that companies ought to have greater freedom to provide additional information to patients about medicines. At the moment, industry’s ability to do this is stifled by the law.”
The NAO report states that the MCA is the only regulatory authority entirely funded from fees paid by the pharmaceutical industry. However, the body that reviews applications by companies, the Committee for the Safety of Medicines, is entirely independent. In light of the increasing range of the MCA’s activities, the ABPI agrees that 100 per cent funding from industry fees may no longer be appropriate.
“It is important to the public and the industry alike that the process of assessing a new medicine’s safety, efficacy and quality is conducted in a truly independent, authoritative way,” said Dr Jones. “These principles have been at the forefront of the ABPI’s constructive relationship with the MCA for many years.”
For further information, please contact: ABPI Press Office 020 7747 1410