Social pharmaceutical innovation and alternative forms of research, development and deployment for drugs for rare diseases.

Rare diseases are associated with difficulties in addressing unmet medical needs, lack of access to treatment, high prices, evidentiary mismatch, equity, etc. While challenges facing the development of drugs for rare diseases are experienced differently globally (i.e., higher vs. lower and middle income countries), many are also expressed transnationally, which suggests systemic issues. Pharmaceutical innovation is highly regulated and institutionalized, leading to firmly established innovation pathways. While deviating from these innovation pathways is difficult, we take the position that doing so is of critical importance. The reason is that the current model of pharmaceutical innovation alone will not deliver the quantity of products needed to address the unmet needs faced by rare disease patients, nor at a price point that is sustainable for healthcare systems. In light of the problems in rare diseases, we hold that re-thinking innovation is crucial and more room should be provided for alternative innovation pathways. We already observe a significant number and variety of new types of initiatives in the rare diseases field that propose or use alternative pharmaceutical innovation pathways which have in common that they involve a diverse set of societal stakeholders, explicitly address a higher societal goal, or both. Our position is that principles of social innovation can be drawn on in the framing and articulation of such alternative pathways, which we term here social pharmaceutical innovation (SPIN), and that it should be given more room for development. As an interdisciplinary research team in the social sciences, public health and law, the cases of SPIN we investigate are spread transnationally, and include higher income as well as middle income countries. We do this to develop a better understanding of the social pharmaceutical innovation field's breadth and to advance changes ranging from the bedside to system levels. We seek collaborations with those working in such projects (e.g., patients and patient organisations, researchers in rare diseases, industry, and policy makers). We aim to add comparative and evaluative value to social pharmaceutical innovation, and we seek to ignite further interest in these initiatives, thereby actively contributing to them as a part of our work.

Health Inequities and the Shifting Paradigms of Food Security, Food Insecurity, and Food Sovereignty.

Global hunger, food insecurity, and malnutrition are on the rise, partly resulting in furthering health inequities between classes and groups of peoples among and within countries. A systematic understanding of the links between inequities in food politics and health issues is a challenge, and it is partly complicated by the presence of 3 contending and shifting paradigms in food politics, namely, food security, food insecurity, and food sovereignty. These paradigms suggest competing views as to the causes of and solutions to hunger, food insecurity, and malnutrition. We argue that food sovereignty offers a better alternative for understanding and responding to food issues in relation to the challenge of tackling health inequities. However, the ways in which and the degree to which the issues of health inequities are incorporated in the current narratives and practices of food sovereignty is rather thin, and vice versa. Our concluding argument is that an interactive dialogue in research and social actions between food sovereignty, on the one hand, and health inequity, on the other hand, can mutually enrich and strengthen both fields of research and spheres of social actions.

A Critical Discourse Analysis of Intellectual Property Rights Within NAFTA 1.0: Implications for NAFTA 2.0 and for Democratic (Health) Governance in Canada.

In 1993, the Canadian federal government ratified the North American Free Trade Agreement (NAFTA). Prior to ratification, compulsory licensing was eliminated from Canada's Patent Act and intellectual property rights (IPRs) were strengthened. Compulsory licensing allows competitors to produce drugs under patent without the consent of the patent holder, challenging drug monopolies and lowering prices, whereas IPRs lengthen patent protections, shielding patent holders from competition and increasing prices. We perform a critical discourse analysis of key provisions in Chapter 17 of NAFTA in light of industry claims that pharmaceutical innovation requires important investments in research and development, justifying high drug prices. We note that since NAFTA, spending in research and development in Canada has decreased and drug prices have increased, becoming a major barrier to equitable access to critically necessary medications. We argue that by modifying the law, the federal government has wronged the Canadian people by discursively appropriating the language of protecting the public good while in practice legitimizing and consolidating private drug development and production, legalizing exorbitant profits, and excluding well-tested publicly financed alternatives. While NAFTA has now been superseded by the Canada-United States-Mexico Agreement, our analysis offers important lessons moving forward.