Friday, October 27, 2006
Generic medicines term FAQ
Frequently Asked Questions about Generic Medicines
- What exactly is a generic medicine?
A generic medicine is the therapeutic equivalent of an originator pharmaceutical product whose patent has expired. It contains the same active substance as, is essentially similar to, and is therefore interchangeable with the originator product.
A generic medicine is produced and marketed in compliance with international patent law. It is identified either by its scientific International Nonproprietary Name (INN) or, less frequently, by its own brand name. Generic medicines are widely used in many EU countries in cost-effective treatment programmes, and are increasingly prescribed by general practitioners as effective alternatives to higher-priced orignator pharmaceuticals.
- Is there a difference between a generic medicine and an originator pharmaceutical?
There is no therapeutic difference between a generic medicine and an originator pharmaceutical. Where there is a difference is on price, where generics are 20% to 80% less expensive than the originator, depending on the national pricing policy and the pricing strategy of originators when facing price competition. Equivalent generic medicines may contain different non-active ingredients (such as colourings, starches, saccharose, etc) which have no therapeutic effect. In certain cases generics and originators may also differ in salts and esters, but these must not affect therapeutic equivalence between the two products. Originator products may also change their non-active ingredients, salts and esters over periods of time.
- Who checks the quality, safety and efficacy of a generic medicine?
As with all other medicines, the quality, safety and efficacy of a generic medicine in the EU is assured, either by the medicines agency of one or all EU Member States, or by the European Medicines Agency in London. To receive market approval, the product must be “bioequivalent”, that is, “essentially similar”, to the originator product. Generic medicines use the same European procedures as originator products and are carefully scrutinised by the competent authority. This registration process takes between 1 and 3 years before market approval is granted.
- Are generics really as good as their originals?
Yes. Generic medicines must comply with exactly the same controls over quality, safety and efficacy as all other medicinal products. They are produced in inspected plants under what is known as “GMP” or “Good Manufacturing Practice”. And, just like originator products, once a generic is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.
- Are generic medicines really less expensive?
Yes, and the savings are significant. Generic medicines cost 20% to 80% less than the original price of their band-name equivalents. In addition, competition from rival generic products forces originators to reduce their own prices after — or even before — patent expiry.
- How do generic medicines benefit patients and the national healthcare systems?
When, as patients, we use generic medicines, we immediately notice the difference in the savings over more expensive originator products. In the same way, our national healthcare systems save money by promoting the use of cost-effective generics, as this frees up money to pay for other, more expensive treatments and services that patients need.
- When can EU patients have access to generic medicines?
Generic medicines can be made available to patients in the EU only after the relevant patents and data exclusivity periods have expired on the originator product.
- How many years does a patent last on an original brand pharmaceutical product?
Pharmaceutical patent protection is longer than in other industries, lasting up to 25 years.
- Can a medicinal product have more than one patent?
Yes. Pharmaceutical products are covered by a number of patents, sometimes by as many as 30-40 patents or more. In addition, a patent on a “new use” can block the registration or marketing of a generic for treatments where the base patent has already expired. This is a strategy used in "evergreening".
- How long does it take to register a generic medicine in the EU?
The registration of a generic medicine usually takes 1 to 3 years, but sometimes longer. Moreover, access to the market is delayed for generics—like originator products—by having to wait for pricing and reimbursement status.
- What is data exclusivity?
Data exclusivity guarantees additional market protection for originator pharmaceuticals by preventing health authorities from accepting applications for generic medicines during the period of exclusivity.
The effective period of market exclusivity gained by the originator company is the period of data exclusivity (currently 6 or 10 years) plus the time it takes to register and market the generic medicine — a further 1 to 3 years.
Data Exclusivity was introduced in 1987 to compensate for insufficient product patent protection in some countries. However, strong product patents are now available in all 25 EU Member States. The rules on data exclusivity have been changed in the new EU pharmaceutical laws adopted in 2004.
- Do generics companies “use” the data of originator products?
Generic applications do not make use of any data of the originator registration file and are approved under the same EU requirements as originals. Since generic medicinal products contain well-known, safe and effective substances, the pre-clinical tests and clinical trials performed by the originator are not repeated. Indeed, it would be unethical and contrary to international convention to do so. The safety and efficacy of a the generic product is cross referenced with the originator product’s dossier by the medicines authorities who alone have access to these files. The data of originator products are never revealed to third parties, and so cannot be used by generics companies.
- Why do generics suffer more than originator products from the lack of a European single market in pharmaceuticals?
Since 1998 EU law has obliged generics to have the same uses and information in all EU countries. However, the originator brands registered before 1998 are allowed to maintain different uses and information from country to country. This makes it very difficult to register and market generics in the various Member States.
