Norman Heatly and Ernst Chain managed to prove the medicinal application of penicillin in 1940, however at the time the UK law did not permit the patenting of chemical substances so it was an American who patented this first anti-biotic and many more drugs were patented by US pharmaceuticals in 50s and 60s. The Association of the British Pharmaceutical Industry (ABPI) with powerful backing from its Swiss and US pharmaceutical members actively lobbied government, which resulted in the Patents Act 1946 thus allowing the patenting chemical substances. A wider offensive was then ensued to streamline patent laws globally. In 1978, the European Patent Convention came into effect; this pharmaceutical-patent paradigm is now entrenched into the EU patent systems. The Indian government Patent Act 1970 prohibited the patenting of chemicals and medicines, as a result the Indian pharmaceutical industry flourished by making affordable generic drug copies for the Indian population. However India had to sign the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) in 1995 as required under the World Trade Agreement by all member states. TRIPS embodies the pharmaceutical-patent paradigm, according to some sources Pfizer played a large behind-the-scenes role in negotiations . Recently the Indians have been accused of securing their role as ‘pharmacy to 3rd world by denying to two American aids drugs patents in favour of the Indian Pharmaceutical giant, Cipla .
Since 1998-2005 US drug companies spent more $758 million on lobbying and have 1,274 lobbyists (that is two for each congress member), which is more than any other industry. This results in favourable regulation to keep out cheaper foreign competition, speedy FDA drug-approval process and a on block negotiations to bring drug prices down . In a 2005 Health Committee report on ‘The influence of the pharmaceutical industry’ UK, Paul Flynn MP described how the pharmaceutical industry had an influence on patient groups by sponsoring them and even using them to subtly promote their products by putting pressure on the government to make these products accessible. Most patient group charities do not name their funders. They also highlighted concerns about the MHRA’s relationship with the industry stating in the opening summary of the report
“The organisation has been too close to the industry a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence... The Secretary of State for Health cannot serve two masters. The Department seems unable to prioritise the interests of patients and public health over the interests of the pharmaceutical industry. We therefore recommend that sponsorship of the industry pass from the Department of Health to the Department of Trade and Industry” (summary p4-5) .
This influence spans from the clinical evidence presented in a licence being biased, the influence on NICE and its perception of evidence medicine, to the pervasive influence this all has on the prescribers and the end users of pharmaceutical medicines. This report is very informative and well worth a read for anyone interested on the influence of pharmaceutical companies.
Global Streamlining: How medicinal product regulation works
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was set up in 1990; it brought together, regulatory agencies, industrial associations and pharmaceutical industry experts from Europe, Japan and USA under one umbrella. The ICH’s aim is to harmonise regulation across the world in order to streamline drug registration processes and speed up the availability of new medicines whilst protecting public health. The above mentioned House of Commons report recognised the strong sway of the pharmaceutical industry in shaping regulatory policies (the secretariat of the ICH is run by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) . They expect this influence to increase through the EU and global streamlining of standards and protocols on medicine regulation.
The ICH makes up guidelines for drug regulation and registration these are submitted to the EU Committee of Human Medicinal Products (CHMP), this committee bases assessments on purely scientific criteria in accordance with EU legislation (Directive 2001/83/EC). Subsequent monitoring of authorised products is carried out by EU national agencies (The MHRA in the UK) . The CHMP then consults the European commission. The European Agency for the Evaluation of Medicinal Products (EMEA ) publishes and distributes these guidelines and a timeline implementation is established . These guidelines eventually become directives and are published by the European Commission, under the Rules for Governing Medicinal Products in the EU. This is under the control of the EU commission for Enterprise and Industry- Pharmaceuticals division . In the US these guidelines are published by the Food and Drug Administration (FDA) .
