PATENT ISSUES & LOCAL PHARMACEUTICAL PRODUCTION IN GHANA. By Kwasi Poku Boateng QUALITY MANAGEMENT CONSULTANT

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1 PATENT ISSUES & LOCAL PHARMACEUTICAL PRODUCTION IN GHANA By Kwasi Poku Boateng QUALITY MANAGEMENT CONSULTANT International Conference on Local Pharmaceutical Production in Africa, Cape Town, April 4-6, 2011 Outline Background Intellectual Property Rights (IPR) and Medicines Regulation interest in Enforcement of IPR Safeguarding Local Production and Public Health through Legislation 1

2 Background Local Pharmaceutical Manufacturers in Ghana mainly produce: antimalarials, antibacterials/antibiotics, antihelmintics, antacids, vitamin & mineral supplements non-steroidal anti-inflammatory drugs (NSAIDS). Background (2) With the current increase in the incidence of chronic conditions such as diabetics and hypertension in Ghana, some manufacturers have began producing oral anti-diabetics and antihypertensives. Most of these medicines are no longer under patent protection. 2

3 IPR & Medicines Regulation In Ghana IPR issues was not considered as a major barrier to local production. The issue came to the fore when a local manufacturer began the production of ARVs in The policy of the local Medicines Regulatory Authority (MRA) then was to require evidence to the effect that the patent of the innovator company has expired before granting a marketing authorisation for generic medicines. IPR & Medicines Regulation (2) The local ARV manufacturer therefore had to seek the consent of the various patent owners (which was granted without any conditions) to be able to produce and market these products locally. Most of these patent owners have not been keen to enforce their IPR in Ghana, a developing country with a population of less than 25 million and an HIV prevalence rate of less than 2%. The MRA has currently reviewed its policy with regards to IPR. It focuses on issues of quality, safety and efficacy which is its area of competence and not enforcement of IPR. 3

4 interest in Enforcement of IPR Possible changes in current HIV/AIDS treatment regimes due to development of resistance, to the use of new generation ARVs which are more expensive and have a relatively longer period of patent protection and recent developments in pharmaceutical manufacturing locally may attract the interest of patent owners with regards IPR. interest in Enforcement of IPR (2) Some of these developments include: Public-Private Partnership for Production of ARVs supported by ECOWAS through its health agency the West African Health Organisation (WAHO). This programme is aimed at supporting; selected local ARV manufacturers to upgrade to meet the requirements of international Good Manufacturing Practices (GMP). local ARV manufacturers to increase their market access by floating tenders for the procurement of ARVs for ECOWAS countries which is open only to 4

5 interest in Enforcement of IPR(3) There is also the Multi-stakeholder programme on Improving Access to Medicines through Pharmaceutical Manufacturing Industry Development supported by UNIDO, This programme is aimed at providing technical assistance to some local manufacturers in Ghana to attain international GMP and possibly obtain WHO prequalification for the products used for the treatment of Priority Endemic Diseases (PEDs). interest in Enforcement of IPR(4) These developments could lead to an expansion in the market access for local pharmaceutical manufacturers and this could pose real competition to innovator companies or patent owners. It is therefore likely that these companies will show an interest in enforcement of IPR. 5

6 Safeguarding Local Production and Public Health through Legislation Ghana is currently reviewing its patent law and attention should be paid to the following issues: The law should explicitly exclude from patentability secondary or further uses of known substances (Using section 3(d) of the Indian Law as a guide) Make provisions for process patents for isolating natural substances or methods for their application to the human body Clearly define the scope of the research exception provision to include commercial research (using Article 9 (1)(b) and 40 (b) of the new Swiss Patent Law as a guide). Include provisions in the law with regards to a Bolar exception. Safeguarding Local Production and Public Health through Legislation (2) The law should expressly indicate that international exhaustion may be applied to situations in which generic products were first marketed on the basis of a compulsory license Include provisions in the law to address the 2003 WTO Paragraph 6 Decision and the 2005 TRIPS Amendment Decision, that enables a compulsory licensee to export up to 100 % of a production to a country in need of certain drugs that it cannot produce itself. These are some of the key issues identified by Ghana s team that took part in the Inwent IP course. 6

7 Progress on the IP Law Review Some of the Inwent IP Course Alumni were involved in the review process. The review is complete The key issues identified above were taken into consideration during the review A recommendation for a policy on data exclusivity was made as part of the review The next steps are the formal legislative process that would have to be taken to get the law passed. Conclusion Addressing these issues adequately will enable the country to take full advantage of the flexibilities of the WTO-TRIPS Agreement. Legislation which fully addresses these issues will also serve as a useful tool to guide the country s negotiators in the economic partnership agreement currently being negotiated between ECOWAS and the EU, so that TRIPS plus provisions are not included in the agreement especially with regards to Public Health issues. 7