Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Concept Paper on the Review of the Regulation of Unlicensed Medicines - Informal Consultation

Deadline for response:

30 June 2008

Background: The purpose of this informal consultation document was to seek the views of stakeholders on the possible reform of regulatory arrangements that exist in the UK which allow an authorised healthcare professional to commission an unlicensed medicinal product to meet the special needs of an individual patient. The regulatory provisions in place in the UK for unlicensed medicinal products have been in place for a number of years. Given the developments that have taken place over the years, there is now a clear case for reviewing those provisions.

The document identifies a range of issues that need to be addressed if the arrangements are to achieve the objectives for which they are intended and meet the principles of better regulation. The MHRA invited views from stakeholders on the issues that are outlined in relation to the regulation of unlicensed medicines and the rationale for reviewing those arrangements.

Introduction:

In most situations under European legislation a medicine placed on the market is required to have a marketing authorisation (ie a product licence) based on demonstration of safety, quality and efficacy. This requirement underpins the whole medicines regulatory system and exists to protect public health. However, the European legislation also contains a derogation, which permits national arrangements allowing an authorised healthcare professional to commission the manufacture of an unlicensed medicine to meet the special needs of an individual patient.

This consultation paper explains the case for reforming the current UK provisions made under this derogation and aimed to generate discussion and ideas for improvement. The paper suggests that it would be helpful to clarify and confirm the objectives of the UK arrangements and identifies a range of issues that need to be addressed if policy objectives are to be achieved in a way that meets the principles of better regulation.

Following an inital period of consultation and exploration of the issues, the MHRA anticipates issuing a further consultation paper setting out specific proposals

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
CONCEPT PAPER ON THE REVIEW OF THE REGULATION OF UNLICENSED MEDICINES - INFORMAL CONSULTATION

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on its Concept Paper on the Review of the Regulation of Unlicensed Medicines.

This concept paper seeks views from stakeholders on the possible reform of regulatory arrangements that exist in the UK which allow an authorised healthcare professional to commission an unlicensed medicinal product to meet the special needs of an individual patient.  The regulatory provisions in the UK for such unlicensed products have been in place for many years, and are due for review and updating.

The stated objectives of this review, listed as bullet points on page 5, are as follows:

• Clinicians should, when appropriate, be able to use their professional judgement to commission supply of an unlicensed medicine to meet the special needs of an individual patient.
• There should be clear responsibility and accountability for protecting the safety and rights of patients.
• Regulatory safeguards should meet the principles of better regulation, including proportionality and targeting.
• These arrangements should complement and not undermine the wider system for licensing medicines.

With regard to the  known issues with medicines regulation listed on page 5 (point 14), the College agrees that removing inconsistencies, such as the different level of regulation applied to imported products compared to those manufactured in the UK, is clearly in the interests of patient safety.

We agree the specific safeguards listed at point 18 are reasonable, but we wish to comment on the last point cited; although regulators should, of course, be able to question the prescribing of an unlicensed product where a licensed one exists, we feel the prescriber should be able to proceed if they are able to justify their choice – for example, if it is in keeping with patient preference.  We feel it is important to retain this flexibility when supported by the informed choice of the patient.

With regard to point 19, we feel that more consistent legislation, more focused on patient safety and clearly stating the necessary safeguards, is desirable to achieve the stated aims, underpinned by improved professional guidance documents and governance arrangements.

Another important issue, not addressed by this concept paper, is recording and notification, which is currently required only for imported products.  In order to achieve more consistency and improved regulation, notification of all use of special medications might be needed. Clinicians are currently obliged to keep records of all special medications supplied for 5 years; we suggest that any future changes to the notification system should not increase the existing documentary burden on clinicians.

In summary, the College agrees that some increase in regulation of unlicensed products is appropriate, and overall we support the proposals of this concept paper.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[30 June2008]