Analysis of Legal Aspects of Local Pharmaceutical Production in Rwanda
(2006; 54 pages)


Rwanda is a Least Developed Country with poor socio-economic indicators, particularly in public health. It has a weak manufacturing base and thus depends significantly upon the importation of products from foreign-based manufacturers. In the case of relatively newer medicines, some of which are covered by intellectual property rights, Rwanda must import from "brand name" manufacturers and where a patent bar does not exist, Rwanda will rely on manufacturers mainly based in India.

With respect to antiretrovirals, Rwanda’s HIV/AIDS treatment programme funded by the international community relies most exclusively on fixed-dose combinations generics imported from India.

Rwandan patent law is obsolete and not in compliance with the TRIPS Agreement yet the country has adhered to the World Trade Organization and accepted to be bound by all treaties from the WTO.

With respect to the TRIPS Agreement, some very important dates, whereby WTO member-countries should be TRIPS compliant, have passed unnoticed for the case of Rwanda. For LDCs (which Rwanda is), a 10-year extension (from 1996) was given to create a viable technological base at the end of which, they would be required to apply the TRIPS provisions. The same provisions stipulate that upon a duly motivated request from an LDC member, the Council for TRIPS shall exempt that member from the 2006- deadline: very little with this regard was done.

Due to the absence of a strong manufacturing base and adequate technologies in LDCs, and considering the fact that many of those countries were facing serious issues in the public health domain, another concession was made and LDCs were allowed up to January 2016 the possibility of waiving the general obligation upon which any person wishing to exploit someone else’s invention should remunerate or compensate the "inventor" also known as the patent-holder. All these provisions (known as the TRIPS flexibilities) are built in the TRIPS Agreement and its subsequent declarations and decisions. To be fully applicable however, these flexibilities and safeguards have to be incorporated in the different national laws.

In all the interviews held with different stakeholders, it was evident that there was an immense lack of awareness on Intellectual Property Rights, on the TRIPS and their implications for the local economy, the overall legal framework and more directly with regard to access to medicines.

Through this report, one could not take the assumption that these laws were known and over the different sections an effort is made to explain the existing laws and the urgent need to update them. The report as well explains the various conditions set by the TRIPS Agreement and their need to be incorporated in national laws. One acknowledges the various efforts that are being made by the Government in putting up a sound and conducive framework to attract investors but wish also that broad consultations are done. Where expertise is not available, the Government should call it upon so that the country doesn’t see all these TRIPS flexibilities that could be turned into an investment opportunity fade away.

From the analysis of the investment framework, the Government is committed to support such a project and has even made this a priority issue in the current Ministry of Health plans. However, one notes with concern challenges that are being faced by the local pharmaceutical industry mainly due to high import taxes of packaging materials as well as the high cost of energy. It was disturbing to find that the only existing pharmaceutical factory has decided to close shop due to what it termed an unfriendly investment climate. This means that there is an urgent need for stakeholders to meet to consider the challenges that are facing the industry if the goal of ensuring availability of low cost medicines is to be achieved.

For ARVs production and other essential drugs, the TRIPS flexibilities can be incorporated in the general drafting of the intellectual property law, to allow possibility to produce such necessary drugs. Other accompanying measures such as the putting in place of a National Drug Authority should be speeded up and its staff properly trained. When all these conditions will be availed, local pharmaceutical production in Rwanda could become a profitable reality for the investor undertaking it and a vital and extremely important tool for the country looking at the welfare of its citizens.

GTZ could play a facilitating role in terms of helping the Government of Rwanda to review together with stakeholders investment conditions targeting the pharmaceutical industry as well as the drafting and incorporation into law the TRIPS flexibilities which could be taken advantage of in promoting access to low cost and affordable essential drugs. This is an opportunity to promote Private Public Partnerships in a sustainable way that addresses practical socio-economic problems in developing countries.

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