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Last Updated: Sunday, 3 October, 2004, 03:25 GMT 04:25 UK
Why we needed to regulate

Generic pills

The 1968 Medicines Act was the first attempt by the government to properly regulate the drugs industry in the UK, and came about as a result of the Thalidomide tragedy.

Up until that point, there was a fragmented series of legislations which were mainly about controlling the quality and promotion of drugs which combat diseases.

In fact, in the 1950s, there was little control over the way therapeutic medicines were manufactured and marketed across Europe.

It wasn't until after the thalidomide tragedy in the late 1950s and early 1960s that things began to change and a stricter, more focussed system of regulation was introduced.

Thalidomide was created in 1953 by scientists in Germany and prescribed as a sedative. It was deemed to be totally safe and because of this it was prescribed for nausea and insomnia in pregnant women and began to be marketed in 1957.

Widely prescribed

However, it became one of the biggest medical disasters of the 20th Century, after thousands of mothers who had taken the drug in the early stages of pregnancy gave birth to deformed babies.

After being licensed, Thalidomide quickly became the drug of choice to help pregnant women who were suffering from morning sickness and within a few years was widely prescribed across Europe.

The drug was initially marketed as having no side effects. However, in the years that followed, as many as 10,000 babies were born with severe problems.

These included blindness, cleft palate, bowel malformations and most notably of all, a severe deformity of the limbs which left some babies with trunks which were lacking either arms or legs.

The drug was withdrawn from the market by most countries, including the UK, in 1961 - although it is still prescribed on a "named patient" basis and is being trialled as an anti-cancer drug.

Voluntary agreement

Thalidomide
Thalidomide was withdrawn in 1962

But the thalidomide incident led to major changes in the way drugs were marketed and controlled in Britain.

Less than two years after thalidomide was withdrawn from the UK market, the government had set up the Committee on Safety of Drugs (CSD), a forerunner to the current Committee for Safety in Medicines (CSM).

It consisted of a panel of medical experts, and although it had no legal powers it had a voluntary agreement with the pharmaceutical industry that no drug should be put on clinical trial against the advice of the CSD committee.

Less than a year after that, on January 1, 1964, the CSD was ready for action in earnest and began taking applications on drugs that companies wanted to put on clinical trial or market to the public.

The committee also introduced many standards which are still in use today. This includes the "Yellow Card" scheme which allows medical professionals to report any adverse side effects of a drug .

Safety

After the 1968 Medicines Act, the CSD eventually became the Committee for Safety in Medicines.

It advises the UK Licensing Authority on the quality, efficacy and safety of medicines in order to ensure that appropriate public health standards are met and maintained.

The Committee has two main responsibilities. Firstly to provide advice to the Licensing Authority on whether new products (to the MHRA) should be granted a marketing authorisation. These responsibilities require close collaboration with the MHRA's Licensing Division.

It also has a brief to monitor the safety of marketed medicines, in close association with the MHRA's Post-Licensing Division to ensure that medicines meet acceptable standards of safety and efficacy.



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