Why intellectual rights are vital for the future of medical research

Date: 25/07/02

By Brian Ager

TODAY, more than 88,000 pharmaceutical industry scientists in Europe are researching new cures and innovative therapies for cancer, heart disease, HIV/AIDS, Alzheimer's, Parkinson's, arthritis, osteoporosis, cystic fibrosis and many other diseases.

Over the last decades, major achievements have been made in the treatment of infectious diseases (like diphtheria and tuberculosis) and childhood illnesses, some forms of cancer, nervous disorders, stomach ulcers, asthma, hypertension and diabetes, to name but a few. Innovation is the lifeblood of the pharmaceutical industry and the key to any improvement in medical care. Pharmaceutical companies are the engines of innovation.

Their key contribution to medical progress is to turn fundamental research findings into innovative treatments that are widely available. The best hope of defeating life-threatening diseases lies in pharmaceutical research, particularly with the further breakthroughs in medical science that we are seeing almost on a weekly basis.

Over the past 20 years, R&D spending by pharmaceutical companies in Europe has risen more than seven-fold. In 2001 alone, the pharmaceutical industry has invested €18.8 billion - almost a fifth of all industrial research and development in Europe, and a higher percentage than any other industrial sector (including high-tech industries such as computers, electronics or aerospace).

Through its heavy investment in R&D, the pharmaceutical industry's constant search for new life-saving and life-enhancing medicines provides new hopes for longer and healthier lives for us and our children. Huge as this investment is, though, it is by no means a guaranteed path to success. Inventing a new medicine is both costly and risky.

It now takes on average 12-13 years for a promising new compound to be extensively tested and eventually approved as a new marketable medicinal product, which puts the average R&D cost for a single new medicine at an estimated €895 million. On average, for every 5,000 to 10,000 new chemical entities invented and developed in the pharmaceutical area, only one will pass every test to become a marketed medicine.

Moreover, around 70 of medicines which eventually reach the market do not provide a sufficient return to recoup their expenditure.

Therefore, since new medicines are so difficult to invent (but so easy to copy), intellectual property rights are vital to secure the revenues for supporting future research. This pipeline of new products also fuels the generic industry - today's new patented products are tomorrow's generics. Both innovative and generic products have a role to play.

A balanced approach is especially needed at a time when there is growing concern about the EU's ability to foster innovation, and is reflected in the recent G10 Medicines Report: 'Patients should have access to new and innovative medicines as soon as possible. However, this must be ensured in parallel with the development of an effective generic market within the EU.'

Innovative firms support fair competition from generic medicine manufacturers when their products become off-patent, which presupposes fair market conditions when their products are still patented, i.e. fast market access for new medicines at appropriate market prices and reimbursed under normal conditions within national health schemes.

Fair competition also requires that any incentive and/or measure that distorts competition by giving preference to any given kind of medicines such as generics should not be allowed. In addition, it is vital to ensure that generic medicines have the same level of quality and safety as original products.

It has been suggested that increasing market penetration of generics in Europe should produce savings in the pharmaceutical budget of member states, which would then be spent on the more innovative medicines. In any event the future of Europe will not be secured by its ability to copy.

We must stay in the race with the US to use our brains to defeat disease.

• Brian Ager is director-general of EFPIA.

Author is director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Article is part of a European Voice survey on Pharmaceuticals.