Doctors and dentists exemption

At present, there are also two other ways of seeking approval for the commencement of clinical trials. These are by means of a Doctors and Dentists Exemption (DDX), or as a Clinical Trial on a Marketed Product (CTMP). 

Notable changes in the UK as a result of the Directive will include abolition of the Doctors and Dentists Exemption (DDX) whereby practitioners have been allowed to prescribe novel agents which they believe on balance to have efficacious advantages that outweigh the risks to their subjects, not on behalf of a commercial organization or other non EU party (6). Furthermore, phase 1 trials in the UK will be subject to exactly the same regulatory agency scrutiny as other types of trials. 

Regulation 3(1) of the 1994 Regulations states that no medicinal product may be placed on the market or distributed by way of wholesale dealing, unless it has a marketing authorisation. This replaces the product licence requirement in section 7 of the act. The exemptions to this requirement are provided for by regulation 3(2) and Schedule 1 to the regulations. They permit supply for individual patients and also enable practitioners to hold limited supplies of stocks of imauthorised medicines. The provisions apply equally to doctors and dentists. 

In view of the regulatory delay that was caused by the need to apply for a CTC, a Statutory Order (SI 1974/498) was made during 1974, to provide an exemption from the need to hold a CTC in such cases, subject to certain conditions. This order applied to trials conducted by doctors and dentists on their own responsibility (DDX). The basis of the clinical trial exemption (CTX) scheme, introduced in 1981, to include studies initiated by the pharmaceutical industry, was that together with a detailed clinical trial protocol and summaries of chemical, pharmaceutical, pharmacological, pharmacokinetic, toxicological and human volunteer studies, a clinical trial in patients may proceed without the need for the additional details normally required for a CTC or Product Licence application. This exemption scheme was based on the requirements that ... 

Sections 31-39 of the Medicines Act, which set out the general provisions governing the conduct of clinical trials in the UK, are unaffected by the 1994 Regulations. The Act pro sddes that a clinical trial must be authorised before taking place, either by the terms of the marketing authorisation of the product involved, or by a clinical trial certificate ( CTC ) (sections 31(3) and 35(1)). Exemptions, allowing use in clinical trials in other circumstances, are contained in the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Pro visions) Order 1972 (exemption for trials initiated by doctors and dentists - DDX scheme), the Medicines (Exemption from Licences) (Clinical Trials) Order 1995" and the Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995" (exemption for company initiated trials - CTX scheme). Both of these exemptions are subject to certain conditions, such as notification to the MCA. 

Originally, the Medicines Act 1968 and associated secondary legislation allowed only doctors and dentists to write prescriptions for POM. The Prescription Only Medicines (Human Use) Order 1997, known as the POM Order, contains some specific exemptions that allow for the sale or supply and administration of certain POM directly to patients, without the directions of a doctor or dentist. These exemptions, which continue to apply, relate to midwives, ambulance paramedics, optometrists, and podiatrists and chiropodists. 

This is an exemption which is available to doctors or dentists who are undertaking clinical trials initiated by them and not at the request of a pharmaceutical company. Outline information about the trial is required and a decision is made within 21 days. Where the product to be used is unlicensed and is complex, further information may be requested and the 21-day period may be extended. 

At the end of the month, all NHS prescription forms are sorted into two main groups (exempt from prescription charge and prescription charge paid) and then by prescriber type (doctor, dentist, etc.) and finally by individual prescriber,... 

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