I was saddened today to read a report in The Independent that accused our industry of exploiting 'loose regulations' for clinical trials in India. This is fundamentally untrue.
The pharmaceutical industry is – rightly – highly regulated. Through global harmonisation via the International Conference on Harmonisation process, clinical trial standards are international.
Our industry is careful to meet these standards. Patient safety is always our priority, and beyond that, if pharmaceutical companies are to be successful businesses then they must work within the regulations. The path to a new medicine can take more than 10 years. There are many stages of research, but only a few compounds complete the journey to become a new medicine because of the demanding criteria of the ongoing selection process.
Research can be discontinued at any time if we find that a compound isn’t proving to be sufficiently effective in treating the target disease, or it has unacceptable side-effects. Thus, medicines are incredibly expensive – costing an average of £1 billion to produce. If the clinical trials do not meet the global regulatory standards, the medicine will not gain a licence. No business would needlessly risk this level of investment, and the pharmaceutical industry is no different.
Clinical trial standards are global. The accusation that this is a 'new colonialism' is completely unfounded. No matter where these trials take place, whether in India or China in the East, or the US and Europe in the West, the standards are the same.
And these trials do take place all over the world – including over 700 applications made in the UK to the Medicines and Healthcare products Regulatory Agency last year.
The report, however, does raise a concern of critical importance. The article suggests that, in India, doctors and members of the Government are not adhering to the regulations. This is a major ethical concern, and should be investigated.
We must not forget why clinical trials take place; without clinical trials we would not have modern medicine. If we wish to cure diseases like cancer, HIV, and Alzheimer’s; find better treatments for diabetes and chronic obstructive pulmonary disease; if we are going to prepare ourselves against future epidemics; and if we want to continue to develop the means by which we improve and save patient lives; then clinical trials will need to continue.
I will read part two of the story with interest tomorrow.
ABPI Chief Executive