(2002; 166 pages)
Generic medicines: old problems and new challenges from a European perspective
Dr John Lisman, The Netherlands
When considering generic medicines, it is important to strike a balance between the public health interest, the interests of the innovative pharmaceutical industry, those of the generic pharmaceutical industry, and ethical values. Public health needs the development of new medicinal products for diseases that cannot be cured at present, as well as the improvement of existing medicinal products and appropriate clinical research. While generic competition can improve the affordability of medicines, quality and comparability have to be safeguarded. For reasons of public health, drug regulatory authorities (DRAs) need harmonized product information that contains all the approved indications for the generic and reference medicinal products.
The innovative pharmaceutical industry is driven by profits, which are most easily made in an exclusive market. Market exclusivity is created by patents, data protection or data exclusivity. Patents are enforced by the industry itself, without the involvement of DRAs. Data protection, in combination with the generally accepted principles of GCP, gives full protection of the product. One of the new types of patent, called a “usage patent”, which gives protection for new indications for an existing product, causes problems for generic competitors. Although market exclusivity is a necessary incentive for companies to develop new medicinal products, sometimes the protecting system leads to too high a level of protection and too long a period of market exclusivity.
On the other hand, generic competition is an incentive for the innovative industry to develop new medicinal products. The generic pharmaceutical industry is also driven by profits, and generic companies want to market their products as quickly as possible. Moreover, the use of generics has to be promoted by the health care system, and their marketing enabled by a good legal system.
Ethical principles should prohibit the repetition of tests and trials. Test and trial results have to be treated as valuable items, to be used for the benefit of society as a whole and not only for the sponsor.
There should be a fair allocation of market exclusivity to maintain a balance of interests between the innovators and the generic industry, in the interest of public health. Drug regulatory authorities should play a firm role in preventing innovators misusing the courts to stop the introduction of generic medicinal products. Generic competition should be welcomed after the period of market exclusivity; before that innovators should compete on the basis of the quality of new medicinal products. Policies for generic prescription and substitution should be in place, but must make sure that the efficacy, safety and quality criteria for generic medicinal products are as high as for the innovative products.