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Generic Medicines

Generic medicines save the NHS billions of pounds a year.1

Medicines will often have more than one name: a generic name (the active or key ingredient of the medicine), and a brand name (the trade name the manufacturer gives to the medicine).

Many of our medicines are what’s called a ‘generic’, and this might be the first time you’ve come across a generic Teva medicine. You can be sure generic medicines contain the same active, or key, ingredient(s) as the original medicine brand.

It’s a little bit like buying the premium brand baked beans at the supermarket versus buying the lower cost alternative home brand of baked beans from the supermarket themselves. The key ingredient for both is still beans.

Generic medicines save the NHS over £13 billion pounds a year.1

These savings mean that when difficult decisions about the allocation of funding need to be made within the NHS, generic medicines have done their part in allowing a proportion of the budget to be freed up so it can be directed to where patients need it.

What are branded (or “innovative”) medicines?

Branded or innovative medicines are new medicines. A new medicine often comes about through the research and development of a new chemical molecule. The developer of that molecule will get regulatory approval for the medicine and a patent to protect their invention. They’ll then produce and sell it, or give permission for others to do so. They will also apply for sole exclusive rights to protect it which, if granted, last for about fifteen years.

When a company develops a new medicine, it is known both by its generic name – the name of the active or key ingredient – and by its brand name, which is the name which the developer sells the medicine under. The brand name is chosen by the developer and is usually something that’s easy for patients and healthcare professionals to recognise and pronounce, it will start with a capital letter and the generic name will be a more scientific sounding name which won’t start with a capital letter.

What are generic medicines?

Generic medicines use the same active or key ingredients as the original brand name products, and are generally available in the same strengths and dosage forms as the original. They also have to be the same as the branded version in terms of quality.

Are generic medicines as safe and effective as brand name medicines?

Yes, if a generic medicine is going to be approved for use it has to be, for all intents and purposes, as safe and as effective as the brand equivalent.

To determine this, each medicine is tested for bioequivalence. This test has to prove that if the generic medicine and the branded medicine were given in the same dose, in the same way, meeting the same standards, their effects could be expected to be the same.

When generic medicines are manufactured, they have to meet the same strict regulatory standards as when brand name medicines are produced.

Does a generic medicine look the same as its brand name equivalent?

Sometimes the generic version of a medicine may have a different colour or shape from its brand name equivalent. These differences have no effect on the way the chemical parts of the medicine work.

Does every brand name medicine have an equivalent generic version?

No. If a generic version of a chemical molecule is not developed by anyone, even after the exclusive rights on an original medicine have expired, the original medicine would still remain the only approved version of the medicine available. Sometimes a generic version is approved and available in a certain country or countries, whilst in other countries the original medicine remains the only version on the market. Other times generic versions are not produced because it costs too much to do so. For example if the medicine is designed for limited use or it is complicated to make.

Having said that, these days, it's rare that a generic version or more than one generic version of a chemical molecule is not developed around about the time when the exclusive rights of the original medicine are due to run out.

How does the original manufacturer protect its medicine?

When the developer of a new chemical molecule believes it has produced a useful medicine, it will probably decide to apply for sole exclusive rights, which, if granted, will last for about fifteen years (developers can then apply for extensions to their period of exclusivity). During the time when they have exclusive rights they will get regulatory approval for the medicine. Then they will produce and sell it, or give permission for others to do so. Also, the brand name of an original medicine is often protected as a trade mark and cannot be used by anyone else.

What are the manufacturing standards for generic medicines?

All pharmaceutical companies have to follow strict quality control procedures and standards when producing medicines whether they are making innovative or generic medicines. They are also regularly inspected by regulatory health authorities.

Many pharmaceutical companies that make innovative medicines also make generic medicines and the manufacturing approval process is complex for both types.

What happens when the exclusive rights on the original medicine run out?

When the exclusive rights on an innovative medicine run out, the medicine may be produced and sold by other companies under a different brand name, or under its generic name, once regulatory approval is obtained. In order to manufacture and market the generic medicine companies must stay within the regulatory health authority guidelines which apply in the countries where the medicine is going to be produced and sold.

What about the quality of generic medicines?

In order for a generic medicine to be approved for use by the regulatory authority, the company has to prove that, for all intents and purposes, it is as safe and as effective as the brand equivalent. To determine this, each medicine is tested for bioequivalence. This means that if the generic medicine and the branded medicine were to be given in the same dose, in the same way, meeting the same standards, their effects could be expected to be the same.

The tests which are carried out are very detailed, for example as well as having the same key ingredient the way and speed at which that ingredient gets into the body’s bloodstream must also be comparable in the generic medicine as it is in the branded version.

Why are generic medicines dispensed?

It takes a lot less time and money to develop a generic medicine than it does to develop an innovative medicine. So, generic manufacturers can afford to sell their medicines for a lower price than those who sell equivalent branded medicines. The generic medicines industry helps save the NHS over £13 billion per annum.1

Without generic medicines, the NHS medicines bill would be approximately twice as much as it is now. The average cost to the NHS of a generic medicine is £3.80, the average cost of a branded medicine is around £20.95.2 Competition from companies who produce generic medicines also encourages researchers within the pharmaceutical industry to develop new medicines.

1 http://www.thetimes.co.uk/tto/health/news/article4570428.ece accessed 18.03.16
2 http://www.britishgenerics.co.uk/ accessed 18.03.16