What are generic medicines?
When the original patent (the exclusive right granted by governments to an inventor to manufacture and sell their invention) of a medicine runs out it becomes legal for ‘copies’ of the original active ingredient to be produced and marketed. These copies, which are medically identical to original medicines, are called generics or generic medicines. Generic medicines contain the same active ingredient and are medically identical to the original, but usually cost less. According to the BGMA generic medicine saves the NHS more than £10bn annually.
Why do generic medicines and original medicines have different names?
When a drug company first develops a medicine the company chooses a brand name under which it markets the medicine. Doctors will often prescribe the medicine using this brand name. When the patent runs out and a generic can be manufactured, it is usually by a rival drug company. The rival drug company may give its generic version of the medicine a new brand name for marketing purposes. Alternatively, the rival drug company may market their generic under the medical name of the active ingredient (International Non-proprietary Name or INN) plus a company name.
For example: the drug company Pfizer developed sildenafil citrate to treat erectile dysfunction and was granted a patent in 1998 for their brand name product ‘Viagra’. Pfizer’s patent for Viagra expired in the UK and other European countries in 2013 and several rival drug companies marketed their own generic brands of sildenafil within weeks of the patent expiry. In November 2017 the same happened with Cialis (tadalafil).
There are many other examples of branded over the counter medicines such as Nurofen (ibuprofen), Lemsip/Calpol (paracetamol), and hay fever remedies costing significantly more than generic versions which contain the same active ingredient.
Patents (and patent extensions) are filed with authorities in each country, and may expire at different times in different countries. Viagra is still currently (November 2017) under patent in the US for example.
Do pharmacists have a choice of supplying original brands or generic versions of a medicine?
When doctors prescribe a medicine, they have a choice of prescribing it by its brand name or the name of its active ingredient (INN). The INN is sometimes called the ‘generic name’. If doctors specify brand names on prescriptions, pharmacists must dispense the brand. If doctors prescribe using the INN, and there are generic versions available, pharmacists can supply the original brand or the generic version.
Is there any difference between original brands and generic versions of medicines?
Generic versions of medicines contain the same active ingredient and are generally medically identical. The packaging, size, shape, colour, taste, coating and other cosmetic features may vary, but the active ingredient and the medical effects are the same. The differences are due to differences in non-active ingredients, such as binding agents, and these should have no effect on the way the medicine works in the body. If there are chemical differences in the active ingredients between the original brand and generic versions, they are differences which should not change the clinical effects of the medicine in the body.
The original branded medicine is the ‘reference’ against which generics are manufactured, and an allowance of 80%–125% of the active ingredient compared to the reference drug is permitted by health authorities.
Why are generic medicines sometimes preferred?
GPs and hospital doctors are often encouraged to prescribe medicines generically (using the INN) because they are medically the same as the original brand, but usually cost less. This saves money for the NHS. If a medicine is prescribed to a patient privately, and the patient is paying the full cost of the medicine themselves, the patient usually pays less if the medicine is prescribed generically (using the INN).
Why are originator brands sometimes preferred?
Doctors, and more particularly patients, often become familiar with particular brands of medicines, which they may have used for decades. They become reassured by the branding and features of medicines, such as its brand name, size, shape, colour, and other features, which may have no bearing on a medicine’s clinical effects. When a generic version becomes available, which doctors and patients know to be medically the same, there may be a reluctance to change to the generic, although once tried, patients will usually be reassured.
The effectiveness of medicines can be related to the confidence placed in them, and concerns about changes, all-be-it not changes to active ingredients, need to be taken seriously.
Who checks that generic medicines are safe and effective?
All medicines marketed in the UK and other EU states are checked and licensed. Rigorous checks are carried out to ensure the active ingredients are correct, and the way it will be released into the body (the bioavailability) is as it should be. These quality checks are carried out by the European Medicines Agency (EMA), or by competent authorities in EU member countries in which the medicines are marketed. In the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA).
The checks on the quality of original brands and generics are the same. They both must be produced in compliance with ‘GMP‘ or ‘Good Manufacturing Practice’. The same standards apply.
Ongoing quality checks
Once approved and licensed, each and every production batch of a medicinal product, branded or generic, must be certified by a Qualified Person (QP – typically an experienced pharmacist, biologist, or chemist) of the EU country of manufacturer, or importer if the medicine was manufactured outside the EU, before being released for sale. The certifying QP ensures that each batch has been manufactured in compliance with the ‘marketing authorisation’ and Good Manufacturing Practice (GMP). Checks include a full qualitative and quantitative analysis of all the active constituents (a small percentage difference is allowed between batches).
The supply chain for medicines is also certified, monitored, and inspected for compliance by regulators at every stage, from manufacturer to pharmacy (Good Distribution Practice).
All medicines in use, original brands and generics, are subject to the same monitoring and reporting for adverse events. In the UK adverse events, such as side-effects, or previously unknown interactions with other medicines, should be reported to the MHRA (Medicines and Healthcare products Regulatory Agency).
Further information: EMA Questions and answers on generic medicines
‘Marketing Authorisation’ and licenses
Medicines obtain a UK license (‘marketing authorisation’) through the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and/or if the product has been licensed throughout Europe through the European Medicines Agency (EMA). If a medicine has a UK license via the MHRA only, and is not licensed centrally via the EMA, or individually by the medicines agencies of other European countries, it can be supplied to patients in the UK only.
Each brand of medicine must obtain a separate license (‘marketing authorisation’), so for instance there are numerous brands of sildenafil licensed in the UK but currently only some brands, such as TEVA and Actavis, are licensed centrally with the EMA and can be supplied throughout Europe. A medicine can only be supplied in countries where there is a marketing authorisation in place for that medicine. Additionally, the packaging and patient leaflet must be in the correct language for a particular country.
How much cheaper are generic medicines?
Medicines marketing is subject to many factors which mitigate against pure competition and therefore prices do not always fall when generic versions of a medicine become available. If a medicine is widely used, and more than one drug company markets different versions of the same medicine, the price can fall by as much as 90%. On-the-other-hand, usually when a medicine is less frequently prescribed, generics may be almost the same price as original brands. There are some rare cases where generics cost more than the originals.
When talking about the cost of a medicine, it is usual to refer to the price pharmacies pay wholesalers. The amount pharmacies charge patients when medicines are supplied privately, or the amount the NHS pays to pharmacies on NHS prescriptions, is usually based on the wholesale prices paid by pharmacies, but there are numerous other factors affecting the cost to patients and the NHS.
The cost of manufacture of a medicine and the prices it is sold for are often only loosely related.
How long do medicine patents last?
New medicines usually remain under patent for around 15 years, although this period may be extended in some circumstances. During this period the originator company will usually try to keep the price high, and will recoup its research and development costs, and endeavour to make profits.
The fact that medicines patents run out stimulates pharmaceutical companies to develop new medicines.
Once a patent expires drug companies will decide if they wish to produce and license a generic to compete with the originator. There is a considerable investment required to launch a generic, even though the generic does not need to go through all the stages required when medicine is new and licensed for the first time.
Can patents be extended and generics blocked?
Yes – this is known as ‘evergreening’. Drug companies usually take out more than one patent on new active ingredients, and may hold patents on slight chemical variations in the active ingredients. This sometimes allows originators to block rivals from developing generics, even after the ‘normal patent’ of 15–25 years has elapsed.
It usually takes 1–2 years for a drug company to go through the process necessary to license a generic, and can take longer still, if the generic is developed to have medically different properties to the original. If a generic is developed in such a way that the active ingredient acts differently than it did in the original, it may take longer and be more difficult to license. If the generic is altered from the original, it will not be an exact medical equivalent of the original. The differences will usually be clear in the way the generic is marketed and prescribed.
What is data exclusivity?
When a medicine is first licensed, some of the research which lies behind it is presented to the licensing authority (the EMA or MHRA). This data is not shared commercially and is protected by data exclusivity. One drug company does not have access to the research and development data of another company. The data is protected intellectual property by data exclusivity.
Which popular brands are available as lower cost generics?
The single most important generic to become available in the last few years, certainly in terms of medicine bought online, is Viagra. This is now widely available as a generic under the name of the active ingredient, which is sildenafil. The wholesale price of sildenafil is about a tenth of the price Viagra, and the cost on a private prescription online on some websites is about a quarter of branded Viagra. See Dr Fox price comparison for sildenafil.
Other medicines which have come down significantly in price are branded Propecia, now available as generic finasteride 1mg tablets. Propecia, which is widely prescribed for male pattern hair loss, usually costs over £1.30 per tablet online. It can now be bought as generic finasteride 1mg for around 45p per tablet (January 2017).
Similarly, there has been a drop in the prices of the malaria tablet Malarone since generics have become available in the last two years. Malarone is the brand name, and the active ingredient and generic name is atovaquone/proguanil, or more usually ‘generic Malarone’ for short. The price of this essential medicine has about halved.
Further information: NHS Choices – brand names and generics