[e-drug] UK Parliament: new critical report on pharm industry (2)

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: UK Parliament: new critical report on pharm industry (2)
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[The MHRA's response to the Commons report 
http://www.mhra.gov.uk/news/selectcommreport.pdf 
Thanks to Andy Gray for spotting this; WB]

PRESS RELEASE
Date: 4th April 2005
Time: 1800
Subject: Response to Health Select Committee report
Contact: Press Office 020 7084 3535 or press.office@mhra.gsi.gov.uk 

Health Select Committee Report

The MHRA is widely recognised as being amongst the most effective and progressive regulators of medicines and medical devices worldwide. Since the creation of the MHRA in April 2003, we have laid down strong foundations upon which we are building upon.

The MHRA takes its role very seriously and has made a number of improvements including
* Acting in patients interest, by being instrumental in becoming the first Member State within the EU to take action on the use of SSRIs in children (in June 2003) and publishing the Expert Working Group's report on SSRIs in December 2004, the most comprehensive review of this product undertaken by any regulator
* Increasing the involvement of patients in the regulatory process by - the
greater involvement of patient and lay members on our advisory committees, patient reporting of adverse drug reaction data and user testing of patient information leaflets
* Introduction of greater transparency into the operations of the Agency -
including the publication of data to supplement regulatory decisions (e.g. in the case of Seroxat and HRT) and encouraging the use of data on adverse drug reaction (ADR's) in medical research and the publication of all ADR's on the MHRA website.
* The introduction of strict new measures on the marketing and advertising of medicines. The key principle behind the guidelines is that they aim to protect the public, by preventing people from being misled by poor advertising. Within these measures is a 'name & shame' system which has been set up to deal with those who fail to meet the standards.

The MHRA recognises the need for further debate about these issues, and indeed we have already taken a number of steps to promote a wider understanding and discussion on these matters.

The MHRA will continue to work closely with our colleagues in the Department of Health to safeguard public health for all.

ENDS
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http://www.mhra.gov.uk/news/pressmedscommission.pdf 
PRESS RELEASE
Date: 5th April 2005
Time: 900 hrs
Subject: Revised Advisory Committee Structure
Contact: Press Office 020 7084 3535 or press.office@mhra.gsi.gov.uk 

New Commission for Human Medicines

Regulations were today introduced to abolish the Medicines Commission and the Committee on Safety of Medicines. The amendments to the Medicines Act 1968 have replaced these with the establishment of a new Commission - The Commission for Human Medicines.

There is now a requirement for a greater degree of expert scientific judgement at the earlier stages of specific product developments and following on from extensive consultation a need for a more transparent structure. The amendments therefore have removed the entitlement provision of industry to be represented on the Commission, have updated the handling of, conflicts of interest and are to increase lay membership on the Committee.

Some specialised Committees will remain and at least 10 new Expert Advisory Groups will be set up to advise them on specific and technical issues. These 'section 4' Committees will be able to advise Ministers direct. Within the revised structure separate arrangements will be made to ensure the views of industry are heard across a wide range of topics.
It is anticipated that there will be a maximum of 18 members plus a Chairperson recruited to this Commission with adverts for positions appearing in early April 2005, the NHS Appointments Commission will be managing this process.

ENDS

Notes to Editor:
1. The British Pharmacopeia Committee will remain as it is an exception to this new structure because it requires specific industry knowledge on the practical application of chemical & pharmaceutical sciences in manufacturing and quality control.
2. Lay members will, in addition to their Commission duties, meet regularly to consider wider medicines regulatory matters.
3. The MHRA is currently consulting on proposals to establish a 'section 4' Herbal Medicines Advisory Committee.