Compulsory patent licensing and local drug manufacturing capacity in Africa

Owoeye, Olasupo

doi:10.2471/blt.13.128413

Cited by 17 publications

(12 citation statements)

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“…Amid concerns that the availability of cheap drugs from Asian producers may soon become more circumscribed (Owoeye 2014), both the Mozambican and Zimbabwean cases demonstrate that such opportunities need to be managed by national governments, as the ARV funds made available by the international community may not be completely secure in the long run, nor sufficiently flexible to be re-directed from internationally procured drugs to locally produced ones, as the current financing of ARVs public procurement in Mozambique eloquently shows. Under these circumstances, investing in the local pharmaceutical industry suddenly appears as a sensible option for national governments, while diversifying away from the lucrative but volatile ARV business may become a necessity for local producers.…”

Section: Discussionmentioning

confidence: 95%

“…On the face of this, compulsory licencing and other TRIPS flexibilities have become key instruments to securitize drugs provision in LMIC (Nicol and Owoeye 2013). Although compulsory licencing has only been used sparingly by African countries (Beall and Kuhn 2012), and can be issued to a foreign third party, some authors argue that only building local manufacturing capacity would allow African countries to take full advantage of the opportunities offered by TRIPS flexibilities (Owoeye 2014). Our analysis of the pharmaceutical manufacturing dynamics in Mozambique and Zimbabwe suggests that the combination of Africa's economic development, improving industrial conditions, guarantees of support from national governments pressing for national drug security and increased drug funds from the international community partly driven by the AIDS epidemic, may be tipping the balance and convince manufacturers to enter the business of local pharmaceutical production in Africa, despite the persistence of doubts on its short-term profitability and viability.…”

Section: Discussionmentioning

confidence: 97%

“…Ballooning drug budgets, compulsory licences, scrapping of import duties in both countries are evidence of the positive dividends accrued to the local pharmaceutical industries by the AIDS factor in the two countries. More recently, concerns on the availability of ARVs from Asian suppliers have contributed to creating a sense that African countries should build up local manufacturing capacity in order to take full advantage of the opportunities offered by compulsory licencing for HIV/AIDS drugs (Owoeye 2014). …”

Section: Determinants For the Development Of Pharmaceutical Productiomentioning

confidence: 98%

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Re-Thinking Pharmaceutical Production in Africa; Insights from the Analysis of the Local Manufacturing Dynamics in Mozambique and Zimbabwe

Russo

Banda

2015

St Comp Int Dev

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Until recently, consensus existed in certain circles that the African industry was not suitable for cost-effective production of quality, safe drugs. Yet, public and private pharmaceutical enterprises have cropped up on the continent, with some venturing into production of sophisticated and complex drugs, such as antiretrovirals (ARVs). In our study, we analyse and contrast the dynamics of local pharmaceutical manufacturing in Mozambique and Zimbabwe with the objective of understanding why pharmaceutical production in Africa is picking up momentum and the influence of global funding for ARVs in this process. Our analysis identifies two routes of development for local pharmaceutical manufacturing: a favourable economic outlook and support from the international community created the necessary conditions for the development of the nascent pharmaceutical industry in Mozambique, while in Zimbabwe, the presence of an established local industry was instrumental in bringing in favourable, if not always coherent, government regulation. In both countries, the introduction of AIDS treatment created windows of opportunity for local production of pharmaceuticals by increasing public sector demand, providing fresh funds, and providing a justification for government regulation favouring local production. Despite the long-standing and well-known problems that created persistent shortcomings in human resources and in the economic and industrial environments, we conclude that pre-existing developmental roots, international funds and supportive state industrial policies are encouraging more manufacturers to enter the business of local pharmaceutical production in Africa. However, the opportunities brought in by fresh AIDS funds St Comp Int Dev

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 97%

Section: Determinants For the Development Of Pharmaceutical Productiomentioning

confidence: 98%

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Re-Thinking Pharmaceutical Production in Africa; Insights from the Analysis of the Local Manufacturing Dynamics in Mozambique and Zimbabwe

Russo

Banda

2015

St Comp Int Dev

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“…Thus, it is argued that the appropriate measure referred to in Articles 8(2) and 40(2) of TRIPS constructively denote compulsory licences. This mechanism is already deemed as one of the appropriate measures capable of preventing the abuse of patent rights which is also consistent with TRIPS by virtue of Article 31, and has been used in the past by several members to prevent abuses, for example, failure to manufacture the patented invention (Owoeye, , p. 214).…”

Section: Compulsory Licences As An Instrument Of Government Policy Tomentioning

confidence: 95%

Examining the Legality of Affordability Requirements as a Substantive Condition for Granting Compulsory Licences Pursuant to the TRIPS Agreement

Manu

2015

World Intellectual Property

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This article examines whether the so‐called reasonably affordable requirements of the public remains a valid condition under TRIPS on which World Trade Organisation members can grant compulsory licences. This article frames its analysis around Section 84 of the Indian Patent Act 1970 in relation to the compulsory licencing case between Bayer vs Natco. The author argues that despite the reasonably affordable requirements of the public not one of the common grounds on which members normally pursue for granting compulsory licences the fact that India has used similar provisions under its TRIPS‐compliant patent regime in granting a compulsory licence to Natco significantly validates the affordability requirements of the public as an independent condition that is consistent with TRIPS on which members can grant compulsory licences. This conclusion is premised on the understanding that no member state has even attempted to challenge the legality of India's decision before the WTO, under the dispute settlement understanding system and that paucity is more supportive of the thesis that, nothing in the light of TRIPS would, in fact, preclude the possibility of other developing countries amending their patent laws to demand that as substantive conditions patentees must satisfy the reasonably affordable requirements of the public.

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“…Moreover, even if a patent is sufficient to encourage innovation and research‐related activities, the current technological capacity and development reality of many developing countries suggest that the role of a patent as an inducement for innovation may be minimal. In sub‐Saharan Africa, for example, many countries (except South Africa), lack the required technological/scientific competence and manufacturing infrastructure to direct industrial and scientific activities towards research‐intensive drug discovery and production activities (Adusei, , p. 120; Owoeye, , p. 214). This means that the ability of developing countries to respond to the incentive rationale of a patent is unlikely (Avafia, Berger, & Hartzenberg, ) .…”

Section: Part Ii: Patents the Trips Agreement And Access To Essentimentioning

confidence: 99%

A re‐evaluation of the framework for the protection of patents, women’s health in Nigeria and the issue of accessing pharmaceutical innovation in Africa: Designing strategies for medicines

Mike

2019

World Intellectual Property

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The objective of this study is to make a case for Nigerian women to have access essential medicines in light of patent protection of pharmaceuticals. Consequently, this study argues for an improvement of women's access to medicines within the context of patent law and rights, the available flexibilities in the international IP regime of the Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement and Nigeria's national patent system. Towards this goal, the article makes the point that patent law and its exclusive rights, both the TRIPS Agreement and national law of Nigeria, do not exist in a social welfare vacuum. The legal text of patent law, which confers rights on inventors when enforced, translates to many other things outside the sphere of property rights; indeed, it can be a matter of life and death. It is argued in this regard that patent right could, in effect, interfere with access to medicines and therefore, the right to health and prospects for human development. This study adopts a doctrinal methodology to examine, analyse, and evaluate the issues that have arisen in the context of patent protection of pharmaceuticals and its effect on access medicines. It concludes that while the hindrances to accessibility of essential drugs in Nigeria are multifaceted and demand a multidimensional approach for a lasting solution, the TRIPS flexibilities are significant means for addressing the challenges of affordable access to important health treatments within the context of patent law. However, it is emphasised that utilising the flexibilities will require that Nigeria's patent system is strategically designed to take full advantage of the available exceptions, safeguards, and options.

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Compulsory patent licensing and local drug manufacturing capacity in Africa

Cited by 17 publications

References 5 publications

Re-Thinking Pharmaceutical Production in Africa; Insights from the Analysis of the Local Manufacturing Dynamics in Mozambique and Zimbabwe

Re-Thinking Pharmaceutical Production in Africa; Insights from the Analysis of the Local Manufacturing Dynamics in Mozambique and Zimbabwe

Examining the Legality of Affordability Requirements as a Substantive Condition for Granting Compulsory Licences Pursuant to the TRIPS Agreement

A re‐evaluation of the framework for the protection of patents, women’s health in Nigeria and the issue of accessing pharmaceutical innovation in Africa: Designing strategies for medicines

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