The legal problem for exporting countries was resolved on 30 August 2003, when WTO members agreed on legal amendments to make it easier for countries to import cheaper generic drugs, manufactured under compulsory licences, if they are unable to produce the drugs themselves. Azevedo said wto agreements should not work in a vacuum and should also support the development and improvement of livelihoods around the world, in addition to other objectives such as environmental policy and public health. Members decided to specifically amend the TRIPS agreement to adapt the rules of the global trading system to the public health needs of people in poor countries. The move follows repeated calls by the multilateral system to adopt the amendment, most recently at the UN General Assembly`s high-level meeting on the cessation of AIDS in June 2016. The mandatory licence must meet certain additional requirements. In particular, it cannot be granted exclusively to licensees (for example.B. the patent holder can continue to produce under the patent) and must in principle be granted primarily for the supply of the internal market. The Doha Declaration acknowledged that “WTO members with insufficient or no production capacity in the pharmaceutical sector may have difficulty in using compulsory licences effectively.” It gave the Adhesive Council a mandate to extend the flexibilities that allow compulsory export licensing11. It was temporary at first,11, but it has recently become a permanent complement to the initial TRIPS agreement13. Imports under the system may include pharmaceuticals, including medicines, vaccines and diagnostic devices. All WTO members are allowed to export under this decision.
But developed countries have pledged not to use the system to import. And some members said they would only use the system for imports in the event of a national emergency or other extreme emergency. “We are far from achieving global justice for access to medicines, especially at a time when the cost of some new treatments is not sustainable, even in the world`s richest countries,” she said. Who chief Margaret Chan welcomed the change, but said much more needed to be done to make patented or unpatented medicines affordable and accessible. The waiver agreed in 2001, which expires at the end of the year, exempts LDCs from the obligations under the TRIPS agreement on patents or other intellectual property rights on drugs and clinical data. This should allow LDCs to purchase and produce generic drugs that are much cheaper than the brand equivalent. The change “helps the most vulnerable access to medicines that meet their needs and helps fight diseases such as HIV/AIDS, tuberculosis or malaria, as well as other epidemics,” said Roberto Azavédo, Director-General of the WTO. The WTO amendment allows exporting countries to grant compulsory licences to generic drug manufacturers, exclusively for the production and shipment of necessary medicines to countries that do not have production capacity.
A patent on a drug issued by a country`s Patent Office gives the company the right to prevent the manufacture, sale and importation of generic drugs in that country. However, it has no influence on the production and distribution of generic equivalents of the same drug in other countries. However, since the introduction of the ON TRIPS agreement, a company can expect to find similar rules on intellectual property protection in all WTO countries. The TRIPS agreement was introduced in 1995 and sets minimum standards for intellectual property regulation in World Trade Organization (WTO) member states 4. Before the agreement is introduced, countries could offri