By Eduardo Urias, UNU-MERIT, urias@merit.unu.edu
@e_urias
For Citation: SITE4society Brief No. 16-2018
Related to SDG Goals: #SDG3 (Ensure healthy lives and promote well-being for all at all ages), #NHM (National Health Mission): Universal Access Programme of Brazil
SITE focus: Technology catch-up, Innovation and Governance for Access;
Country Focus: Brazil, Emerging Countries
Sub-Disciplines: Economics of technology, innovation and development, Public Health
Based on: Ramani, Shyama V., and E. Urias. “When access to drugs meets catch-up: Insights from the use of CL threats to improve access to ARV drugs in Brazil.” Research Policy 47, no. 8 (2018).
Acronyms: CL: Compulsory License; MoH: Ministry of Health; IPR: Intellectual Property Regime; TRIPS: Trade Related Intellectual Property Rights System PPP: Public Private Partnerships
Context: In macro-economics, catch-up refers to the hypothesis that poorer economies’ per capita incomes will tend to grow at faster rates than richer economies. A similar notion is applied to technological capabilities, wherein countries or individual firms can catch-up in relation to the technological frontier by reverse engineering existing technologies and tailoring them to suit local conditions. 
Catch-up is important for policy makers, because of the underlying implicit assumption that if production is increased, then its trickle-down benefits would improve access to commodities, in terms of their availability and affordability. For most products, these trickle-down benefits are left to be determined by markets, with the state being held accountable for catch-up in terms of the technological, innovative and industrial capabilities upstream, and the quality and safety of goods reaching final consumers downstream. However, for some essential commodities and services, like medicines, access is also deemed to be the responsibility of the government, and not to be left to markets alone. This leads to a question largely understudied in the catch-up literature. Can the need to improve access to an essential commodity impact the sectoral catch-up trajectory of the corresponding industry?
When a country is faced with a high disease burden and has to improve access to the
corresponding drug, its response is affected by its level of catch-up and whether or not the drug is patented. The manufacturing of small molecule drugs involves two main operations in decreasing levels of complexity and knowledge intensity: production of ‘active pharmaceutical ingredients’ (API) and drug formulation. The wider the scope of technological capabilities over the production process, the higher the catch-up in pharmaceutical manufacturing. For emerging countries with limited API production capabilities, the problem may become untenable, if drug manufacturers are unwilling to supply adequate quantities at acceptable prices and/or the corresponding technology cannot be licensed from the supplier and developed independently by other firms.
For our research queries, the Brazilian catch-up experience in the production of antiretroviral (ARV) drugs required by HIV/AIDS patients presents itself as an ideal
trajectory to study. In 1996, Brazil initiated a policy of universal and free access to highly-active ARV therapy (HAART) (or simply Universal Access Policy), which put an enormous pressure on the Brazilian Ministry of Health (MoH). In order to ensure an adequate supply of ARVs in the public healthcare system with a limited budget, MoH started negotiating price reductions for high-cost patented drugs, often deploying the threat of using compulsory license.
Compulsory license (CL) is a provision in the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS) that allow a government to permit third parties to produce the patented product without the consent of the patentee. This is a measure that has been purposefully introduced to minimize the potential negative impact of patents on access to medicines. Scholars have confirmed that the CL option empowers developing countries to negotiate prices with pharmaceutical companies more aggressively (Beall et al., 2015; Beall and Kuhn, 2012; Ramani and Urias, 2015).
Research Questions: For an emerging country with limited manufacturing and innovation capabilities, what are the possible inter-temporal impacts of sectoral catch-up in pharmaceuticals on access to life saving drugs and vice versa?
Furthermore, what insights can be gained from the interrelationships between price negotiations of essential patented drugs, access and catch-up?
Data and Methodology Used: A mixed methodology is applied to answer our central questions. The literature is first examined and its main findings on catch-up and access are summarized as theoretical constructs through figures. Then, ARV price negotiations data compiled from diverse secondary sources are analysed. A case study is constructed from the above, complementing it with primary data obtained from 26 semi-structured and exploratory interviews with stakeholders familiar with the Brazilian experience in price negotiation for ARVs. The case study method is applied, because it is suitable for studying complex contemporary social phenomena, when boundaries between a phenomenon and its context are not clearly evident. Moreover, since the number of observations of CL threats in Brazil is not sufficiently high to justify a statistical analysis, the case study method is more appropriate.
Main findings and discussion:
- Catch-up in the manufacturing of an essential commodity need not automatically lead to better access, but public agencies can play a crucial in creating such synergies.

The catch-up literature mainly portrays it as a process within the production space of an innovation system. Like standard macroeconomic theories of growth, catch-up frameworks of income convergence and sectoral studies seem to assume that access for local consumption will improve through catch-up.
However, the literature on access to medicines, points out that, for catch-up to improve local access to essential commodities, going beyond markets, there is a need for public actor bridging of the production and consumption sub-systems. In the
Brazilian case, the MoH served that role, demonstrating that it is possible for public agencies focusing on access rather than on knowledge or firm capabilities enhancement to do the same. These confirm the observations that growth benefits may not trickle down to improve poverty alleviation unless the system, especially the state and public agencies, nurture structural changes and capability building for pro-poor growth (Kakwani et al., 2000; Nussbaum and Sen, 1993).
- Past catch-up, even if aborted, can nurture better access in the future and present need to improve access can trigger future catch-up.
The Brazilian industrial policy implemented since the 1970s to build technological and innovation capabilities was directly responsible for the success of the Brazilian health policy to tackle the HIV/AIDS epidemics, even though there is a consensus that this policy failed to build a competitive pharmaceutical industry and reduce trade deficits in
pharmaceuticals. Skills in fine and organic chemistry accumulated locally, notably at Farmanguinhos and in a handful of private companies in the 1980s, created absorptive capability and prior knowledge bases for the local production of ARV drugs. Furthermore, compulsory licensing enabled accumulation of technological capabilities for API and formulation of key drugs like efavirenz, only because of absorptive capabilities developed over prior aborted catch-up. Thus, with respect to an essential commodity like medicines, sectoral catch-up can have a strong inter-temporal relationship with access.
- interactions and struggles, the impact of instruments used to ensure access can be nuanced and not clearly favour either access or catch-up.
In turn, with respect to the ongoing debate about whether promoting catch-up in the pharmaceutical sector is likely to be harmful for access to medicines, or whether the two can be complementary, our results indicate that neither argument can be generalized. Evaluation has to occur on a case by case basis even within the same country.
- For emerging countries under TRIPS: (i) lack of access can be a necessary condition to trigger catch-up, though it need not be sufficient. (ii) catch-up led access improvement will depend upon international regulation and building of organizational capabilities of local firms.
In order to ensure access to essential commodities like medicines, countries with the requisite resources and capabilities are engaging in gradual build-up of industrial capabilities. However, if the need is urgent, prices can be negotiated and alternative
corridors are available, with one of them being compulsory licensing. Drugs developed after 2005 are subjected to patent protection in emerging countries and thus their exports would demand a CL under the Paragraph 6 system of TRIPS Agreement. However, this involves enormous procedural challenges at present and must be tackled. Public private partnerships (PPP) and international partnerships are viewed as crucial for catch-up under TRIPS. Brazilian companies such as Cristalia, Orygen, Bionovis, Libbs are engaged in both.
Policy Recommendations:
First, emerging countries with basic technology and innovation capabilities ought to invest in closing the knowledge gap in essential drugs production. The Brazilian case study indicates that given the paramount role of local technological capacity in bargaining with patent holders, public policy should support technological capacity building.
Second, for emerging countries, there can be real trade-offs between catch-up and access. As the Brazilian case study amply illustrates, price discounts by MNEs for their
patented drugs improve access, but they slow down catch-up, because then it becomes even more challenging for local firms to become equally competitive. Similarly, following a CL or initiation of a PPP, while there will be catch-up, access might be improved more by importing cheap generics than by procuring costlier locally produced drugs.
Third, especially for emerging and developing countries, a strong public sector would be a good source of bargaining power. It is not necessary for the public sector to undertake manufacturing of drugs, this can be left to the private sector. However, the public sector must have state of the art technological and innovation capabilities so that it can transfer technology to local firms whenever necessary. Thus, emerging countries must invest in the development of well performing public sector entities to close the knowledge gap in drugs production for their important disease burdens.
All tables and figures are detailed in the article.



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Context: In rural India, where 68.84% of the population lives, the 2011 Census reported that 69.3% of households are without toilets, even though toilets had been diffused by the government since the mid-1980’s. However, about 54% have mobile phones. Interestingly, from the view point of the Indian rural communities, both mobile phones and toilets are ‘innovations’ as they are new to them. Both are pro-poor, i.e. artefacts with the potential to improve their quality of life and livelihood possibilities; but, unlike mobile phones, lack of toilet usage is deemed a critical risk for environmental hygiene and public health. Now, in any innovation system, whenever there is a crisis that needs to be addressed for social welfare, and markets and public programs somehow fail to do it, then social entrepreneurship is expected to emerge and address the needs-gap.
Both social entrepreneurs and social enterprises have overlapping objectives and require similar capabilities, but there is a major distinction. Social enterprises behave like corporate ventures in the social sector, tackling a problem only if they can leverage adequate resources to achieve their financial targets, whereas social entrepreneurs practise entrepreneurial effectuation and are more likely to make do with what they have to work towards their social mission. Given the above, the study of the evolution of sanitation coverage in India forms an ideal setting to explore the potential role of social entrepreneurship as a carrier of pro-poor innovations.
Social enterprises are getting embedded more densely within innovation systems worldwide, because financiers are interested in social impact, but lack knowledge on the BoP communities. Hence, they are seeking social enterprises to implement their welfare enhancing BoP projects. Here, social enterprises serve as catalysers to transform the resources from the providers into innovations for the intended beneficiaries such that there is a social welfare enhancing transformation. That said, given the systemic uncertainties and challenges associated with the BoP context within a constantly evolving innovation system, how does such outsourcing perform? This query is worthwhile, because while policy makers and scholars recognize that within a national innovation system, social entrepreneurship has a crucial role to play as an innovation carrier, they are much less clear on how the system ought to catalyse this process for optimal social impact.
social entrepreneurs will be the main actors. This was confirmed by the sectoral case study. In India’s pre-liberalization period, i.e. before 1991, passion-driven social entrepreneurs, Mahatma Gandhi and Bhindeswar Pathak being notable examples, strived for maximal social impact with whatever resources they could mobilize. The situation changed completely thereafter.
depends on an action taken by the agent, which may not be observable. Further, the principal may not be able to fully confirm some of the agent’s characteristics such as the latter’s true intentions about fulfilling the contractual obligations or engagement. Thus, when financiers interested in making a social impact, say toilet usage, hire social enterprises on the basis of trust, despite incomplete information about the latter’s capabilities or intention, they take strategic risks that are no different from those taken with organisations in mainstream markets. Strategic uncertainty stemming from incomplete information about social enterprises can pose risks at the level of partner selection and thereafter in contract implementation. Adverse selection or inadequate selection processes may lead to the hiring of an ill qualified partner. Thereafter, imperfect monitoring systems and/or incentive systems can allow for moral hazard in the form of inadequate effort by the social enterprise. Both these problems can lead to sub-optimal outcomes as illustrated in our case studies.
not be supported as ‘demand’ i.e. willingness to pay. After adoption, there can be abandoning, and thus ‘adoption’ need not be maintained or sustained. This is because in BoP markets, there is often a gap in perceptions of innovation value between the provider and intended beneficiaries. Unless this gap is breached, the intended beneficiaries are not motivated to adopt the innovation efficiently. The innovation providers may not be aware of other challenges faced by intended beneficiaries such as lack of financial resources, ownership of required complementary assets (say water for toilet use), knowledge and skills for usage and maintenance of the innovation provided. Again, if these problems are not tackled, the social impact will be sub-optimal, as the dynamics of toilets abandoning revealed in our case study.
Sustainability audits should be introduced for social enterprises: While striving to create an enabling environment for social entrepreneurship, long term impact evaluation audits must be conducted to identify and reward ‘sustained social impact’ makers. For this purpose, devising guidelines corresponding to the sector or pro-poor innovation concerned, along with workshops for the social enterprises on the quality and sustainability of their initiatives can promote early systemic dialogue for best possible impact. Social enterprises have to be induced to go beyond provision of knowledge, technology or products for immediate impact to catalyze efficient adoption for sustained social impact.















Sukumar Vellakkal, BITS Pilani Goa





men. There are two possible explanations of this observed gender difference. First, it may be due to the socioeconomic differences between the two genders. However, it has been demonstrated that results remain true even after controlling for education, employment status, and many other individual socioeconomic characteristics that may explain this gender gap, leading us to question what the underlying factors are that explain this political preference difference between men and women. Second, it could be caused by th
choices may hinder the much-needed legitimacy of democracy in Africa. However, previous research strongly indicates that gender discrimination in social institutions has negative economic and social repercussions. For instance, discriminatory social institutions have been shown to slow down the achievements of some of the Millennium Development Goals, including food security, fertility and education (See, OECD(
The way women are treated in a society determines their political participation and their degree of support for democracy. When women live in a friendly environment that protects their rights and freedom, they have a high degree of support for democracy. However, institutions that are discriminatory toward women could decrease the level of support that a country needs to promote democracy. 


Emanuele Pugliese, Institute of Complex Systems, CNR, Rome and Department of Economics, University of Bath, emanuele.pugliese@gmail.com



For example, our study indicates that in the Indian manufacturing sector, R&D spending is good for firms, which are younger, exporters, with high capital investments and low financial leverage, while R&D spending might not yield much benefits for firms that have never done R&D before. In short, R&D investment is not for everyone!
Hence, firms that do not do R&D could be having good reasons to do so and vice-versa. This would indicate that a homogeneous economy wide tax breaks on R&D might not be an optimal policy. Innovation policies should be sector and technology specific, and any incentive should be shaped considering the characteristics of the firms involved. This is important to maximize the effects of the incentives, to ensure that firms do not undertake R&D for mere tax benefits, without any innovation output.
The AYUSH Gram project in Karnataka is an example of such a Government-sponsored programme under the public-private partnership (PPP) model. 
changing cropping patterns.









By Dr. Arijita Dutta, Department of Economics, University of Calcutta,


