United Kingdom Pharmaceutical Industry

Trevor M. Jones The Association of the British Pharmaceutical Industry London, United Kingdom Jerome P. Skelly Alexandria, Virginia... 

The findings of these studies are in accordance with an earlier study performed by the British economists Taylor and Silberston. Based on a survey of R D managers in the United Kingdom, they estimated that pharmaceutical R D expenditures would be reduced by 64% in the absence of patent protections. By contrast, the corresponding reduction was only 8% across all industries. Similar findings were reported by Edwin Mansfield, in a survey of the research directors of 100 U.S. corporations. ... 

In the United Kingdom, the information sheet provided to the consenting study subject in a clinical trial sponsored by a pharmaceutical company will usually contain a reference to the clinical trial compensation guidelines of the Association of the British Pharmaceutical Industry (ABPI). It is not included in the information sheet of noncommercial studies. Study subjects taking part in clinical trials are not usually paid, unless it is... 

There should be consistency between the possible adverse events described for the study drug in the protocol, investigator s brochure and ICF. Most coimtries have specific requirements for their ICF. It is essential that the requirements are known when the country-specific ICF is prepared. These examples could easily have changed by the time the reader is checking an ICF. In the United Kingdom, reference should be made to the ABPI (Association of the British Pharmaceutical Industry) Clinical Trial Compensation Guidelines. In other countries, for example, Ireland, the study subject is allowed a specific length of time to decide whether to enter the study. 

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

In the United Kingdom, healthy volunteer studies were subject to self-regulation by the pharmaceutical industry and consequently only the clinical trials in patients had to be covered by a CTC. However, as stated earlier, clinical trials in the UK are now regulated under EU Clinical Trials Directive (2001/20/EEC) fully implemented in the UK. 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

The prices of medicines sold to the NHS are controlled in the United Kingdom by the PPRS, negotiated periodically every 5 to 6 years by the DoH with the Association of the British Pharmaceutical Industry (ABPI), for example in 1979, 1986, 1993 and 1999. The PPRS controls the maximum - but not guaranteed - profits that pharmaceutical companies make on the capital they have invested in plant for research, development and manufacturing for sales made to the NHS. (Capital employed by the individual companies... 

United Kingdom Parliament (UKP). 2005. The Influence of the Pharmaceutical Industry. London TSO. Available at http //www.publications.parliament.uk/pa/cm200405/cmselect/ cmhealth/42/4202.htm [Accessed October 20, 2005]. 

British Pharmaceutical Industry London, United Kingdom... 

Similar approaches were adopted by major regulatory authorities in other countries, including the United Kingdom, France, Germany, Italy, and Scandinavia and subsequently the European Union. The official agencies and the pharmaceutical industries own experts have published recommendations for a wide range of types of toxicity tests to provide comprehensive data in stardardized form for assessment. 

---