Safety of Medicines Bill

policy-safety-medicines-bill–v2.jpgThe Safety of Medicines Private Member's Bill 2010–2011 was backed by a pressure group called the Safer Medicines Campaign. The Bill is supported by very few scientists and doctors, and was not supported by the UK government.

The Bill’s sponsor argues that 'animal tests have let us down badly in their role of protecting us against dangerous drugs'. The related EDM 475 was signed by 150 MPs. The Bill was due for debate in the House of Commons in autumn 2011, but it did not get parliamentary time so was rescheduled for January 2012.

The Bill proposes 'establishment of a Medicines Safety Evaluation Panel to compare the effectiveness of human biology-based tests and animal-based tests in assessing the safety of medicines. The panel would be required to report within two years and would have full access to all relevant records' held by the Medicines and Healthcare Products Regulatory Agency (MHRA).

We believe that the benefits of any such review would be limited and it would represent a waste of valuable resources.

Adverse drug reactions

It is a myth that adverse drug reactions are somehow caused by reliance on animal-based safety tests. In fact, new medicines are tested on far more people than animals. The majority of serious side-effects are predictable and avoidable. When medicines are taken according to prescribing information and the prescribers know about other medicines being taken by the patient, many serious problems can be avoided.

Rare adverse effects (occurring in less than 1 in 1000 patients) may  not be detected until a medicine has been used for some time. This is because the medicine will have had to be prescribed for at least a  thousand people before a single incident of a rare adverse effect occurs. It is quite possible that rare adverse effects will not be detected during either animal studies or clinical studies in humans prior to licensing.

Safety testing using animals

The need for new medicines to be safe and effective is well-recognised, and is a key concern for regulators and for the bioscience sector both in the UK and across the world. In fact, the vast majority of new medicines that reach the market do indeed prove to be reasonably safe after animal and non-animal tests and human trials. All these methods are used alongside each other to get the best information possible on safety.

Of course, no medicine can be guaranteed to be free of side-effects,  and most side effects which do occur are due to the primary activity of the medicine (for example anticoagulants might cause bleeding), to interactions with other medicines, or to improper use.

Animal methods are the only ethical way to test the effects of a potential new medicine at normal or high doses in a living animal for  the first time.

For more information, please also see our briefing on Animal Testing & the Safety of Medicines Bill, a recent letter published in The Lancet, and our popular booklet Where Do Medicines Come From?