Over the past years, scientific and technological innovation has broadened the scope for improvement in health conditions relating to malaria, tuberculosis and most recently avian influenza, which has continued to create major problems in many parts of the world. The patent system is designed in a way to promote technological innovation while ensuring that the worldwide population is benefited from the same.
R&D in Drug Industries:
Generally, any new development in drug industries amounts from heavy investments along with long-term research. Once, the drug is manufactured, the next stage is clinical trials and regulatory approval procedures. The motivation for necessary investments into the research for developing new drugs is derived from the exclusive right, which is conferred by a patent for a period of 20 years. The ownership and licensing policies associated with the innovations plays a major role in the promotion of effective deployment of general public funds and research and development programmes. The current patent system makes the process conducive by making the information about the innovations available to the general public that is freely available to other researchers from the same background to make improvements on the existing technologies.
Protection of Innovation in Drug Industries:
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced a new and important international framework for IPR, which in turn has an important implication on the health sector. Some of the obligations in respect of the protection of innovations include1:
- to recognize patents for inventions in all fields of technology, with limited exceptions;
- not to discriminate with respect to the availability or enjoyment of patent rights;
- to grant patent rights for at least twenty years from the date of application;
- to limit the scope of exceptions to patent rights and to grant compulsory licenses only under certain conditions;
- to effectively enforce patent rights.
World Trade Organization (WTO) countries are obliged to comply with the TRIPs agreement. In implementing the TRIPs provisions, WTO member countries can, however, develop their own patents and other intellectual property laws in response to the characteristics of their legal systems and developmental needs. Different countries treat patent issues such as exclusive rights, compulsory licenses and scope of protection in different ways. For example, developing countries have their own IPR policies and rules and further, has scope for devising and implementing their own solutions on specific matters. On the other hand, developed countries opt for legal systems that confer strong patent rights. Countries that are less technologically advanced, have a preference to promote technology transfer required for development and to enhance competition in order to secure access to goods, services and technologies on the most favorable market terms.
The protection of public health is one of the most critical issues in developing countries. A large part of the world's population still lacks access to necessary drugs. For instance, in Africa, over 50 per cent of the population lack that access. An estimated 1.5 billion people are not expected to survive till the age of 60, and more than 880 million people lack access to healthcare.
Procurement options for developing countries:
Developing countries can explore the following options to make medicines available to their citizens at a low price:
The TRIPs Agreement provides many options to deal with the issue of patents. The most important is to provide compulsory licensing including "government use" licensing. A compulsory license authorizes a person to use the patent other than the patent
holder. Article 31 of 3the TRIPS Agreement permits a compulsory license to be granted for any purpose, with certain conditions such as "adequate remuneration" to the patent holder, and non-exclusive licensing rights.
The consumers and procurement authorities can purchase generic or off-patent medicines, which are no longer covered by patents and are available in the market at low prices.
By parallel importation, countries can identify the lowest price for the marketed medicines and import them without the consent of the patent holder in the importing country.
The countries can make an attempt to negotiate with the patent holders for the lowest price. It is evident from the fact that many Pharma companies have already offered discounts to the poor countries for medicines such as antiretrovirals used to treat HIV-AIDS. The procurement authorities in the respective country play an important role to negotiate at a better price.
Objective of public health goals can be achieved by including people from both general and private sectors, through authority help, authorizing of innovation, joint endeavors and different modalities. The viability of such task heavily relies on developing country, wherein the developed countries need to relinquish the utilization of one-sided activities for acquiring the security of business interests of their patent holders in the developing countries. The above-mentioned worldwide co-operation would help in recognizing the basic rights of any individual to access the health care and further helps in the government's commitment to secure and promote general health.
1 Integrating Public Health Concerns into Patent Legislation. Available from http://apps.who.int/medicinedocs/en/d/Jh2963e/5. 1.html
2 Integrating Public Health Concerns into Patent Legislation...http://apps.who.int/medicinedocs/en/d /Jh2963e/5.1.html
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