Access to medicines in the Democratic Republic of the Congo and the United Republic of Tanzania from a least developed country perspective

Acronyms and Abbreviations

Acknowledgements

Attempting to provide an exhaustive inventory of the help I received during the many years devoted to the conception, writing, and completion of this thesis would be a risky and incomplete task. Therefore, I am thankful to all people who participated in completing this work in one way or another. Mainly, I am grateful to my supervisor Prof. Dr. Markus Krajewski, for his guidance, insightful comments, and critical observations, which contributed to the improvement of my dissertation. Despite his multiple occupations and responsibilities, Markus kindly fulfilled his role of Supervisor (Doktorvater), even beyond the sole scientific and academic spheres. My gratitude goes to Prof. Dr. Andreas Funke, who replied to my request for potential supervision, centering my attention on Prof. Krajewski. My thanks go to the Friedrich-Ebert Foundation for financial support, which fully funded my doctoral research.

My special thanks to Prof. Dr. Yves Junior Manzanza, who motivated me to undertake my doctoral studies in Germany and shared the official website from Prof. Andreas Funke. I also thank Prof. Dr. Laura Clerico, who kindly admitted me to her seminar as part of my admission requirement to the doctorate program and agreed to review and evaluate my dissertation.

I am also grateful to Prof. Dr. Ndjoko Karine Loset, who motivated me to obtain an external Ph.D. student status in one of the universities in the Netherlands before applying for a NUFFIC grant in 2013. Also, I am grateful to Prof. Dr. Fons Coomans for kindly agreeing to be my supervisor and supporting my application to Maastricht university’s law school and the NUFFIC program. Unfortunately, destiny decided otherwise. In my application process as an external Ph.D. student at Maastricht University, I also received significant assistance from Dr. Jennifer Selling, who acted as a co-supervisor in providing valuable comments on my proposal. Thank you very much, Jennifer. Special thanks to my parents Marc Mumbanika Musag’i and Sophie Ngunza, for their tireless support and moral and spiritual accompaniment. Especially my father has constantly advised me to be patient and follow in the steps of Prof. Yves Manzanza who also completed his Ph.D. in Germany. Furthermore, I am thankful to my family, consisting of my wife Berthie Niary and my two kids, Marc Berdinho and Brady Dadinio, for their patience and love. My thanks also go my brothers and sisters, Marie-Louise, Ismael, Agapy Manzanza, Clara, Kenda, and Madeleine, for their love and support. I am also grateful to all my Congolese professors and teachers for their encouragement, especially Kumbu JM, Omeonga, Nzundu, Ngwabika, Mulengi, and Kangulumba.

Last but not least, my profound thanks to my friends, namely Rhode, Fiston Kafulu, Dadou Boto, Mimie Malu, Assaam, Kweta, and Guy Kipulu, for their encouragement and support.

I. General introduction

People in the least developed countries, such as the Democratic Republic of the Congo (DRC) and the United Republic of Tanzania (URT),¹ need medicines more than anyone else. In addition to common diseases that can affect everyone’s health irrespective of location, Congolese and Tanzanian people face peculiar ailments in the African environment, such as neglected tropical diseases, malaria, cholera, yellow fever, and Ebola.² Furthermore, people’s ability to access medicines of good quality that are available and accessible for all is doubly affected by the countries’ status and their socioeconomic status.³ Regarding the country’s status, the DRC and URT are among the world’s poor countries,⁴ facing the problem of poverty which renders them incapable of providing the necessary amenities, infrastructure, and resources that facilitate the full enjoyment of the right to health,⁵ including access to medicines of good quality. The country’s developmental level is a crucial factor upon which depends the full implementation of access to medicines as part of the right to health.⁶ Without relieving least developed countries of their ←13 | 14→obligations regarding the right to health, States and other entities in the position to assist should grant them international assistance and aid,7 allowing them to implement access to medicines within their jurisdictions. It is essential to stress that the development level of a given State also affects or influences adopted implementation measures. For example, in the URT and DRC, there is no compulsory universal health coverage or good legal conditions that allow individuals to claim access to medicines before the courts.⁸

The citizens of URT and DRC lack sufficient means to afford existing available medicines, despite their lower health status and higher needs for medicine.⁹ Financial constraints also hinder individuals’ capability to claim access to medicines through complaint procedures before human rights treaty bodies, such as the African Commission of Human and Peoples’ Rights,¹⁰ and the African Court of Human and Peoples’ Rights.¹¹ Other factors that impede access include the shortage of medicines within public health facilities, the absence of medication for African diseases, the high price of available drugs of good quality, the presence of bad quality medicines,¹² and the irrational use of medicines through self-medication. Overall, people’s access to medicines of good quality in the least developed countries, including the URT and DRC, is limited.¹³ While taking into ←14 | 15→account the country’s developmental level, the present study deals with the legal protection of access to medicines as an essential component of the human right to health.

A. Justification of the legal approach for access to medicines in DRC and URT

The legal dimension of a human right to health, including access to medicines, is based on its recognition as a legitimate standard within international and domestic laws.¹⁴ A human rights-based approach¹⁵ to medicines considers States, namely the DRC and URT, as duty bearers, responsible for meeting their legal obligations in that regard through implementation measures consistent with human rights, on the one hand. It also considers individuals as rights holders, entitled to make claims for redress of violation of their right to health, on the other hand.¹⁶ Indeed, both the DRC and URT are committed to the legal protection of access to medicines at the international and domestic levels through the ratification of human rights treaties and the adoption of laws and regulations.

At the international level, for instance, the DRC and URT are Member States of the United Nations Organization (UN),¹⁷ the African Union (AU),¹⁸ and the Southern African Development Community (SADC),¹⁹ the constitutive Charters of which make provisions for the protection of human rights and health-related issues through individual and collective efforts.²⁰ More importantly, they have ratified specific human rights instruments adopted within the framework of these organizations, which expressly protect the right to health, including access to medicines, from different perspectives. The International Covenant on Economic, Social and ←15 | 16→Cultural Rights,21 provides for the right to the enjoyment of the highest attainable standard of physical and mental health while the African Charter provides for the right to enjoy the best attainable state of physical and mental health.²² Further ratified treaties cover access to health services for all,²³ children’s health care, and universal access to HIV AIDS treatment.²⁴

The human rights treaties entitle individuals to lodge complaints before established supervisory bodies for any violation of the right to access medicines by the State parties concerned.²⁵ Furthermore, as duty-bearers, the governments of the DRC and URT are under treaty’s obligations to implement access to medicines either through individual efforts only²⁶ or through both individual and collective efforts, including international assistance and cooperation.²⁷ These implementation measures shall ensure the availability, accessibility, and acceptability of access to medicines and provision for remedies in case of its violation.²⁸

At the domestic level, each country has its human rights protection system. In the DRC, for instance, as the supreme law of the land, the DRC Constitution protects all the categories of human rights, whether civil and political rights (CPRs), economic, social, and cultural rights (ESCRs), and collective rights.²⁹ The Constitution provides for the right to health under article 47, which reads as follows, “the right to health and food security is guaranteed. The law establishes fundamental principles and organization rules relating to public health and food security.” It is plausible to argue that the concept of the “right to health” is inclusive of access to medicines. Furthermore, the DRC Constitution consecrates the monist approach, in which ratified human treaties have precedence over national laws other than the Constitution.³⁰ Like under ratified human rights treaties, the DRC Constitution ←16 | 17→subjects the implementation of the constitutional right to health to a range of implementation measures,31 including the enactment of the law on public health. Using the current DRC Constitution as a starting point, one can regroup existing implementation measures on access to medicines into two main categories. The first category includes laws and regulations adopted before the coming into force of the DRC Constitution, including at the colonial time. They mainly comprise the 1933 Ordinance on the practice of pharmacy,³² the 1952 Decree on the practice of medicine,³³ the 1958 Ordinance on the exercise of medicine and application modalities,³⁴ the 1972 Ordinance Law on the exercise of pharmacy,³⁵ and the 1972 Ordinance on the implementation of the 1972 Ordinance Law.³⁶ Other measures include the 1991 Ordinance Law establishing the National Board of Pharmacists³⁷ and the 2002 Decree on the exercise of traditional medicine.³⁸ The second category comprises some laws and policies adopted after the coming into force of the DRC Constitution, such as the Public Health Law,³⁹ the Law on people living with HIV (the HIV Law),⁴⁰ the Law on the rights of the Child,⁴¹ and the Law on the rights of women,⁴² the National Strategy of Strengthening Health System,⁴³ and ←17 | 18→the 2011-2015 Health Plan of Action.44 The Constitution vests all the courts and tribunals with a common and general human rights jurisdiction.⁴⁵

Like in DRC, the 1997 URT Constitution is the primary legal text that protects all human rights in the URT.⁴⁶ Unlike the DRC Constitution, the URT Constitution’s Part III relating to basic rights and duties does not contain any provision dealing explicitly with the right to health or the specific right of access to medicines. Instead, Part II on fundamental objectives and directive principles of State policy refers to, among others, the right to social welfare at times of sickness, the protection of other human rights following the Universal Declaration of Human Rights (UDHR), and the eradication of disease,⁴⁷which can cover access to medicines. However, unlike basic rights, directive principles of State policy are not judicially enforceable.⁴⁸ Following the country dualist tradition,⁴⁹ courts in the URT can only apply ratified human rights treaties after their domestication or incorporation into the municipal law.⁵⁰ To implement the treaty and constitutional provisions on access to medicines, including the protection of public health,⁵¹ the URT has adopted an important number of legislations, regulations, and programs. These include the 2003 Tanzania Food, Drugs, and Cosmetics Act, the 1982 Disabled Persons Act, the 2007 Environmental Health Practitioners Act, the 2007 Health Laboratory, Practitioners Act, the 2008 Mental Health Act, and the 1999 National Health Insurance Fund Act. They further include the 2002 Traditional and Alternative Medicines Act, the 2008 HIV and AIDS Act, the 2009 Public Health Act, the 2011 Pharmacy Act, the 2009 Law of the Child Act, and the 1998 Health Sector Reform Programme. All these implementation measures have in common the fact that their enactment is posterior to the 1977 URT Constitution.

However, despite the above legal framework, access to medicines in the DRC and URT remains still a very challenging concern, especially in rural areas.⁵² ←18 | 19→Without undermining the impact of a country’s poverty on people’s access to medicines, the present study examines the extent to which the existing human rights law applicable to the DRC and URT addresses the questions of quality, availability, accessibility, and enforcement of access to medicines.

B. Selection of the countries

The country studies are selected based on their similarities and differences in respect of their applicable human rights law on access to medicines. To begin with elements of similarities, a common issue to the DRC and URT is that their constitutional provisions on the right to health are not well known to the general public, including experts in the field. Indeed, contrary to the protection of the right to health under the Constitution of the Republic of South Africa, which is presented as a shining example in Africa,⁵³ some studies on the constitutional protection of the right to health in Africa ignore, if not underestimate, the relevant provisions of the DRC Constitution and URT Constitution.⁵⁴ Furthermore, in addition to being poor countries facing similar economic, social and structural problems, both the DRC and URT have the same treaty’s obligations regarding access to medicines at the international, African, and SADC levels. Finally, like the Traditional Medicine Act on the practice of traditional medicine in the URT, the Public Health Law in the DRC recognizes traditional medicine (TM) as an essential component of the national health system.

However, the legal systems from the DRC and URT, including some legal aspects regarding the protection of access to medicines, are different. For instance, the DRC follows a continental European legal tradition with elements of French ←19 | 20→and Belgian law whereas the URT is a member of the Common Law family. In addition, Congo’s legal system adopts a monist approach with regard to the relationship between international and domestic law,55 whereas Tanzania is a dualist country strictly separating international and domestic law.⁵⁶ Consequently, unlike under the DRC law, where civil courts and tribunals can directly apply ratified human rights treaties,⁵⁷ under the domestic law of URT, the courts can only apply domesticated human rights treaties.⁵⁸ Furthermore, unlike the DRC Constitution, which provides for an explicit constitutional right to health, the URT Constitution deals with health-related rights, including access to medicines, as part of the directive principles of State policy through the protection of other human rights and the right to social welfare. Moreover, unlike under the DRC Constitution, where access to medicines is theoretically justiciable, the URT Constitution does not make it judicially enforceable. Therefore, how these differences play out when it comes to the implementation of the right to health and access to medicines is of interest.

C. Research questions

Four main questions form the backbone of the present thesis. The first question relates to the legal basis for access to medicines in the DRC and URT, consisting of domestic laws and ratified human rights treaties. The second question looks at whether differences in the constitutional references to the right to health and the country’s monist or dualist approach towards ratified human rights treaties also lead to different results in implementing access to medicines within the country studies. The third question examines whether the scope of the right to health protected under ratified human rights treaties and domestic laws is sufficiently enough to include TM. Finally, the fourth question looks at the extent to which the comparative approach can allow the country studies to learn from each other in improving access to medicines within their respective jurisdictions.

D. Study hypotheses

The present study is built upon the following hypotheses. First, the DRC and URT are committed to the legal protection of modern and traditional medicines and have already taken some relevant implementation measures in that regard. However, they need other legal steps for adequate access to medicines, including ←20 | 21→adopting new laws and regulations and amending some existing laws. Moreover, despite the potential for an explicit constitutional right to health59 under the DRC Constitution and its monist approach towards ratified human treaties, the DRC appears in many respects similar to the URT as a dualist State which protects access to medicines as a non-justiciable right. Likely, despite the inferior status of the constitutional right to health and the country dualist approach towards human rights treaties under the URT Constitution, the URT seems in many respects as a country with an explicit constitutional right to health in its implementation of some aspects of access to medicines. Finally, without government political will in implementing access to medicines, the differences regarding the constitutional protection of the right to health and the country’s monist or dualist approach would remain theoretical without concrete improvement of people’s enjoyment of their right to medicines.

E. Methodology

The primary method used in this study is desktop research based on written sources. Used materials were collected by visiting libraries, searching the internet, including the official websites of the African Commission, African Court, SADC, UN, AU, treaty bodies, and national health Ministry of the URT and DRC. In addition to the field study conducted in DRC, I have obtained some electronic versions of documents through email communications from URT contacts. Like any other legal doctrine, collected materials consist of normative and authoritative sources.⁶⁰ Normative references consist of, among other things, statutory texts, Constitutions, regulations, and human rights treaties. Authoritative sources comprise mainly case law that is not binding precedents, scholarly legal writings, and the jurisprudence and works of the CESCR, the African Commission, the African Court, and the SADC Tribunal.