African pharmaceuticals will not immediately benefit from the amendments to the World Trade Organisation’s intellectual property laws that recently came into force.
The WTO Trade Related Aspects of Intellectual Property Rights (Trips) restricted firms producing medicine under compulsory licences — without consent of the patent holder — to trading them within the country of manufacture.
A revision to this law allowing pharmaceuticals to export generic medicine to developing countries unable to produce them was adopted in 2005, but remained ineffective.
Five states — Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Vietnam — recently endorsed the amendment, giving it life beginning January 23.
Companies in Africa will take time to extract value from this opening since many lack the capacity (mostly financial) to manufacture the generics before seeking regulatory approvals to exploit the export market.
Trips, which has been in force since 1995, can only be used to manufacture drugs of great national importance or to mitigate national disaster such as HIV/Aids, tuberculosis and malaria, which claim the lives of millions every year.
However, since these products are held under patent, their manufacture by third parties had to be controlled to safeguard the interests of the rights holder and meet minimum production standards.
One of the intellectual property rules prescribed that these medicines could not be sold outside the borders of the country where a third-party pharmaceutical is producing them.
International organisations such as the United Nations argued that this regulation was harmful to developing countries that are “facing public health problems but lack the capacity to produce drugs.”
To access the Trips market, companies must ensure that their medication and facilities are of a standard that allows them to compete in the global pharmaceutical market.
WHO and the Food and Drug Administration are among the regulatory bodies whose hard-to-get green light is needed prior to selling these generics.
The amendment (new Article 31bis) to the 1994 Agreement on Trips and Public Health, allows countries producing generic medicines under compulsory licence to export medicines to least-developed countries that lack manufacturing capacity themselves.
It came into effect once two-thirds of the WTO membership ratified it. The number needed kept climbing as new members joined the WTO over the years and now stands at 164 members.
According to the amendment, governments can now issue compulsory licences to allow companies to make a patented product or use a patented process without the consent of the patent owner, but only under certain conditions aimed at safeguarding the legitimate interests of the patent holder.
It is hoped the amendment will help patients suffering from HIV/Aids, tuberculosis and malaria, as well as other epidemics. Member states who are yet to accept the Trips amendment currently have until end of December 2017 to do so, WTO said.
The original amendment was pushed by the African Group. Two of the group’s members, Uganda and Mozambique, currently, are building their own capacity to manufacture generics, but the cost of production is high.