Product Licences of Right

The products already on the market on 1 September 1971, the date for implementation of the Medicines Act, were given the Product Licences of Right (PLR) that were subject to a review process at a later date. This proposal for review of PLRs is reminiscent of the FDA contract with the National Academy of Sciences/National Research Council (NAS/NRC) in 1966, to evaluate the effectiveness of some 4000 different drug formulations approved on the basis of safety alone between 1938 and 1962 - the year of the Kefauver-Harris Amendment. 

The following minimum standard particulars are required to appear in an advertisement, differentiating between the Public, and Persons Qualified to Prescribe or Supply (PQPS). The particulars are not required on promotional aids which do not incorporate promotional claims and featuring no more than the product name, trademark protection, and company name. All particulars must be compatible with the product s Summary of Product Characteristics. Special particulars apply to registered Homoeopathic medicinal products, and to medicines subject of Product Licences of Right. 

At the start of product licensing in the United Kingdom in 1971, products already on the market were granted Product Licences of Right (PLRs), which were subject to review. Between 1971 and 1982,22 376 lapsed or were revoked or suspended, and 598 had been converted to full product licenses. The Committee of Review of Medicines was deemed to have completed its work in 1991 and was disestablished on 31 March 1992. 

By its existence, the Medicines Act recognises the right of the pharmaceutical industry to advertise and promote its products, and by the standard provisions for product licences it is possible to control product... 

DuPont had been granted rights to grant non-exclusive sub-licences of the ICI Patents. Union Carbide approached DuPont in October 1942 for a sub-licence, whilst simultaneously contracting to supply the Navy with PE, building a 500-ton PE plant, and then improving the process and product. By the end of the war. Union Carbide had increased their capacity to six times that of DuPont, who were now making 750 tons per annum. Applications were found in extmded film, coated paper, wire and cable insulation, bottles, and pipes. 

An exclusive, worldwide licence to Product X in perpetuity with the right to manufacture and develop the product further for a payment of 10 million and a following royalty of 5 per cent of net sales for 10 years. ... 

This could lead Company B to respond that they would agree to an exclusive world licence to Product X but would retain manufacturing and development rights and want a payment of 25 million and a 15 per cent royalty for 20 years on gross sales. 

The converse of this situation also applies. The company should have a system in place, usually assigned to R D, which thoroughly checks its own proposed new products and processes, to ensure that it will not infringe somebody else s intellectual property once they are commercialised. If there are conflicting patent rights then a licence to operate will need to be sought from the inventors. 

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