Vision for sustainable access to innovative medicines: GHLG & UMCG’s Global Health Unit respond to the OECD

By: Katrina Perehudoff, Global Health Unit Department of Health Sciences, UMCG Groningen, katrina.perehudoff@gmail.com

Excessively high prices of innovative medicines threaten patient access and health system sustainability in developing and industrialised countries alike. The Organisation for Economic Co-operation and Development (OECD) has launched a new initiative to facilitate high-level dialogue between stakeholders on access to innovative medicines and the sustainability of prices. On April 30, 2017, members of the GHLG Research Centre and the Global Health Unit in the Dept. of Health Sciences at the University Medical Centre Groningen responded to OECD’s online consultation for sustainable access to innovative medicines. Below are excerpts from our response.

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Recent changes in the Spanish health care system from a right to health perspective – PhD research by María Dalli

By María Dalli (PhD researcher at the Human Rights Institute of the University of Valencia, Spain; currently visiting scholar at the University of Groningen)

In 2012, Spain adopted significant legislative changes with regard to the universal right to health care. Due to these changes, the universal right to health care is currently at risk. In order to allow for a better understanding of the relevance of these measures, I will briefly outline the evolution of the Spanish National Healthcare System (NHS) as well as the recent changes. Subsequently, I will explain the main objectives of my research and the extent to which it can contribute to offering an adequate answer to these problems from a right to health perspective.

The healthcare system in Spain evolved from the Bismarck model (the social security model)  of the 20th century to the Beveridge model. The Beveridge model is characterized by universal access and redistribution through a funding mechanism and was initiated through the passing of the General Healthcare Law of 1986 (HGL, 14/1986, 25th April). Subsequent laws (Law 16/2003 and Law 4/2000) regulate the rights of non-nationals. According to these laws, foreigners without legal residence status were also covered by the NHS after they had registered at the municipality. During the last decades, the Spanish healthcare system has thus been universal, financed through a progressive tax system and, as such, separate from the socials ecurity system. However, the recent measures introduce significant changes with regard to the groups that had originally been protected by the system. Consequently, the universal right to health care is under pressure.

Presently, Royal Decree 16/2012, states ‘insured’ and ‘beneficiaries’ as categories entitled to access the NHS. A person can be considered as insured if she/he is registered in the social security system (through being employed, retired or unemployed in search of employment). A beneficiary is a family member of the insured or is dependent on the insured. Such a categorization means that the access to the NHS is tied to the social security system despite the fact that the health care system is tax-funded. This is especially concerning as it means that every person living on Spanish territory is contributing to the tax system and thus to the funding of the NHS, while still not necessarily having access to the health care services of the NHS.

However, an important exception is made for persons whose annual income is below 100.000 €: they still count as insured. This exception does not apply to undocumented migrants or EU citizens not registered at the Official Register of Foreign Citizens. As a consequence, undocumented migrants and unregistered European citizens do not have regular access to the NHS as they are usually not registered in the social security system and are explicitly excluded from the possibility to count as insured on the basis of earning less than 100.000 € per year. However, there are three exceptions to the denial of access to the NHS for undocumented migrants and unregistered EU citizens: 1) emergency care, 2) health care to children under the age of 18 and 3) pre- and post-natal care.

According to the Ministry of Healthcare, more than 676.000 people have been excluded from the NHS in Spain in the last three years. Fortunately, the Royal Decree 16/2012 has been challenged by political parties and different Autonomous Communities. For this reason, Spain is currently waiting for the verdict of the Constitutional Court, which is responsible for guaranteeing the fulfilment of the fundamental rights and the Spanish Constitution.

In my thesis I explain these current changes within the Spanish NHS. In the following, I will explain the main questions that I try to answer in my research project.

From a legal philosophical, constitutional law and international law perspective, I try to provide possible solutions to the recent challenges in the Spanish health care system. From a right to health prespective, I analyse the universality of this right in relation to material equality and in relation to the organization of the health care systems on the basis of such characteristics. The thesis is supervised by Professor of Legal Philosophy María José Añón (University of Valencia), and co-supervised by Professor of Constitutional Law Gerardo Pisarello (University of Barcelona).

The research highlights the importance of the universality and equality of the human right to health. With regard to the universality, I therefore analyse the three main arguments that are alleged against universality and defend a position that takes into account the theory of basic needs. The classic models of organization of the healthcare, within the typical Welfare states, usually pay attention to poverty, work or citizenship. Hence, the aim of my research is to show that the subject of the right to health is not the poor, the worker, or the citizen (national or legal resident) but rather the human being as such. In terms of substantial equality, I focus on the theory of the indivisibility and interdependence of all human rights so as to defend the influence of the socioeconomic factors in health – especially in light of the concept of the ‘social determinants of health’ mentioned in General Comment 14 of the United Nations Committee on Economic, Social and Cultural Rights (health thus relates to issues such as the influence of food, housing, security etc.).

The main question of my thesis is thus the following: how can the human right to health be designed in accordance with the principles of universality and substantive equality?

Understanding the right to health from this point of view leads to the following subquestions:

  • What are the limits of the universality of the right to health under the international human rights framework (for instance, the concept of affordability versus ‘charity’)?
  • How can we design a healthcare system according to the characteristics of universality and equality in light of the previous contributions of the classic models of health systems (Beveridge and Bismarck)?
  • What does this mean for the recent changes in the universal health care coverage of the National Healthcare System in Spain?

All of this will hopefully provide an adequate answer to the recent changes in Spain from a right to health perspective which can show that such regressive measures are in breach of the concept of progressivity and of the prohibition of regressivity.

Human rights and public health; towards a balanced relationship

Brigit Toebes, University of Groningen

Does the right to health embrace claims to public health? And how should we exercise such claims? In international law there are many references to the protection of public health contrasting with other interests, including the interests of trade, commerce, intellectual property protection, transportation, and warfare. Potentially, in such contexts,  the ‘right to health’ as an economic and social right can be used as an additional collective claim to advance the health of the public, thus counterbalancing such interests as international and domestic trade and the conduct of warfare. While this approach has potential, it should be born in mind that public health measures potentially infringe on the civil and political rights of individuals, including their rights to privacy and freedom of movement. We are thus dealing with a complex relationship between public health, human rights, and international law that is still ill-understood. An integrated approach to human rights, taking into account both civil and political and economic, social and cultural rights, seems the most balanced response to public health concerns.

Read more on this matter in an article by Brigit Toebes in the International Journal of Human Rights, available athttp://www.tandfonline.com/doi/pdf/10.1080/13642987.2015.1044814 and also available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2448860