Intellectual Property Rights (IPR)
Intellectual property rights are exclusive rights, often temporary, granted by the state for the exploitation of intellectual creations. Intellectual property rights fall into two categories: rights relating to industrial property (invention patents, industrial designs and models, trademarks and geographical indications) and those relating to literary and artistic property (copyright). The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) covers the main categories of intellectual property law.
Once IPR have been established, the property cannot be copied or used without the agreement of the owner.
Intellectual property rights regimes are national or international systems that protect and enforce IPR through legally binding frameworks for registration and penalties. At an international level, the World Intellectual Property Organization oversees a number of treaties for the promotion of IPR.
In the health sector, intellectual property rights can provide an important stimulation for the development of new drugs and medicines. However, a significant proportion of the world's population, especially in developing countries, have yet to derive much benefit from innovations that are commonplace elsewhere. The reasons range from weak supply systems to unaffordable prices. The factors that drive innovation are often biased against conditions that disproportionately affect the populations of developing countries. For example, of the
1 325 new medicines launched between 1975 and 1997, only 11 were specifically for tropical diseases. Innovation to address conditions primarily affecting poor people is held back by a combination of market failure and under-investment by the public sector. The process of bringing a new product to the market is both expensive and lengthy. Because of the resource implications and the uncertainties involved, creating an environment conducive to successful innovation is essential.
The exclusive right to market a product during the life of a patent allows the holder to recoup some or all of their initial investment, by charging more for the product. This in turn has an impact on price, which affects access to medicines. Although price is only one of the factors that determine access, it is a highly significant one. Three recent studies, each using different methodologies, predict price increases of twofold or more once the TRIPS agreement requirements are fully implemented in developing countries.
Reconciling the needs of patients and patent-holders is a challenge to efforts to improve access to essential health care. Given the potential impact of intellectual property rights on price, there has been a growing interest in mechanisms designed to bring about the most favourable pricing for developing countries. Relaxed patent requirements, tiered pricing, voluntary licensing, compulsory licensing, bulk purchasing and corporate donations have each been evaluated as potentially effective mechanisms to achieve the most favourable pricing of patented medicines in developing countries. The analysis suggests that those approaches which facilitate competition have the greatest impact on reducing prices.
These approaches need to be evaluated both individually and in combination to ensure that the balance between exclusive patent rights - and the investment stimulus they provide - is balanced against the objective of reducing prices. The impact of these approaches needs to be monitored in different national contexts.