Regulatory compliance within the pharmaceutical industry

There are a number of challenges facing the pharmaceutical industry in the coming years. The rate of new drugs brought to market has slowed significantly and companies are dealing with a wide range of issues, not least of which relate to heightened regulatory demands.

According to the Association of British Pharmaceutical Industry, it typically costs as much as £1.15 billion to develop and market a new treatment - a process that often takes more than 12 years. And when you consider the fact that 95 per cent of all experimental medicines studied for human treatment fail to achieve safety and efficacy approval, it is clear to see how some of the larger companies in the industry are spending billions of pounds across their new medicine portfolios.

This comes as the commercial environment is becoming more and more difficult for drugmakers, with healthcare authorities increasingly imposing new constraints on costs and conducting in-depth studies to ensure the value of the medicines they are receiving.

At a time when generic alternatives to branded treatments are being produced on a large scale in countries like India, organisations such as the UK's National Institute for Health and Care Excellence - which is responsible for determining the drugs that are made available on the NHS and is required to consider expense as a key factor - are becoming less willing to pay the inherent premium for new treatments.

The higher cost reflects the company's extensive research and development and is a guarantee of the quality of the ingredients and processes involved in the manufacture of the treatments, but a large number of the drugs accepted by NICE in recent years have required the firm responsible for them to significantly lower its cost demands or agree to a patient access scheme.

In a 2012 edition of the Nature Reviews Drug Discovery journal, it was shown the number of new drugs brought to market per billion dollars of research and development (R&D) spend has roughly halved every nine years for the past half a century.

This is demonstrative of the fact pharmaceuticals place a much higher demand on R&D than other aspects of the chemicals industry - on average costing three times as much to propose and develop a medical treatment than an industrial chemical product.

Aside from the expense relating to R&D, manufacturers are facing ever-increasing costs relating to regulatory compliance. While drugs must be approved by the US Food and Drug Administration for marketing in the US and the European Medicines Agency within the European Union, there are also a range of factors relating to the production processes.

The REACH regulations that came into force across the EU in June 2007 comprise an 849-page document, which even after extensive studying, many observers believed did not affect the pharmaceuticals industry. However, while any substance present in a medical product is exempt from the legislation, those used during the manufacturing process that are not a component of the treatment are not. This means that any reagents, process aids and solvents which may be utilised during API synthesis must be REACH compliant.

Strict controls are required in order to ensure there are no breaches of this or any of the range of other regulatory demands imposed on pharmaceutical manufacturers, pushing the costs related to drug development even higher.

Robinson Brothers is fully-REACH compliant and registered, and has extensive experience in dealing with companies within the pharmaceutical industry and delivering the chemical intermediates they require.