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Regional Pharmaceutical Patents Continue to Hinder Access to Medicines in Uganda

In 2014, Uganda adopted the Industrial Property Act, with a landmark clause excluding pharmaceutical products from patenting at least until 1st January 2033.

Despite this positive move, pharmaceutical patents continue to be a barrier. The Africa Regional Intellectual Property Organization (ARIPO) administers the filing and grant of patents for 18 countries in sub-Saharan Africa including Uganda and annually churns out hundreds of pharmaceutical patents that apply to Uganda inconsistent with its national law.

The exclusion of pharmaceutical patents in the 2014 Act is aimed at addressing the massive challenge of access to medicines in Uganda. Notably it is also to promote its potential as a manufacturer of generic medicines, following in the footsteps of countries that developed a robust pharmaceutical sector due to the absence of pharmaceutical product patents.

India, excluded pharmaceutical product patents in 1970, creating the pathway to be a leader in the manufacture and export of quality affordable generic medicines. Nations globally are dependent on India as the “pharmacy to the world”. Bangladesh, a least developed country, suspended the granting of pharmaceutical product patents in 2008, a key factor in its emergence as a significant player in the global generic pharmaceutical sector. Historical development of the pharmaceutical sector in the rich countries is also instructive as the origins may be traced to the lack of pharmaceutical patent protection.

Uganda’s precedent setting pharmaceutical waiver clause is consistent with the requirements of the World Trade Organization’s Agreement on intellectual property commonly known as the WTO-TRIPS Agreement and international expert recommendations. The WTO-TRIPS Agreement features special rights for countries designated as least developed country (LDC) by the United Nations.  Recognizing that LDCs have economic, financial and administrative constraints, and need policy flexibility to create a viable technological base, in 2015, the WTO granted all LDCs the right to refuse the granting of pharmaceutical product patents at least until 1st January 2033, with the option to renew it in the future.

The effect of patents on the affordability of medicines is an international concern. When a medicine is patented, it grants the patent holder a monopoly for at least 20 years. In 2000, patent holders of life-saving antiretroviral treatment charged $10,439 for a year’s supply of the treatment. The high price tag meant patients living with HIV/AIDS were mostly condemned to death. Entry of affordable generic versions of the treatment dropped prices significantly over time to less than US$100 crucial factor in the global scaling up of HIV/AIDS treatment.

Impact of patents on access to affordable treatment is likely to be more acutely felt with the rise of non-communicable diseases such as cancer and the prohibitively high cost of treatments. A 2018 technical report of the World Health Organization notes “Cancer medicines under the protection of intellectual property are unaffordable to patients and health care systems in low- and middle-income countries” and recommends that countries use flexibilities provided by the WTO-TRIPS Agreement to address the patent barrier. In this context, the flexibility of exemption of pharmaceutical product patents granted by the WTO and adopted by Uganda’s patent law is the right step forward. Apart from Uganda, several other African LDCs such as Rwanda, Liberia and Zanzibar have implemented this flexibility nationally. 

In 2012, the Heads of States of Africa adopted a Road-map on Shared Responsibility and Global Solidarity for the AIDS, Tuberculosis and Malaria Response in Africa: treating prevalence of infectious diseases “as an emergency for the region”, raising concern also that national responses to AIDS, TB and other infectious disease are highly dependent on external financial and foreign produced medicines and that this “dependency poses grave risk to the Continent”. The Road-map zoomed in on the LDC pharmaceutical waiver as a crucial policy tool to create a sound and viable technological base in the pharmaceutical sector in the region.   

Similarly, the African Union Pharmaceutical Manufacturing Plan for Africa and the East African Community Pharmaceutical Manufacturing Plan of Action for 2017-2027 identifies the under utilisation of TRIPS flexibilities as one of the major obstacles to the development of a viable pharmaceutical manufacturing on the African continent; stressing on full exploitation of WTO-TRIPS flexibilities including the LDC pharmaceutical waiver.

Uganda is well-placed to exploit these opportunities to promote its nascent generic manufacturing capacity as evidenced by the partnership between Cipla a well-known Indian generic company and Quality Chemicals, a local Ugandan company formed which continues to date as CiplaQCIL. This partnership is borne out of concern that countries with established generic manufacturing capacity will be barred from supplying generic versions of patented medicines, and to exploit Uganda’s status as an LDC with freedom from patent protection.  

While forward steps are taken at the national level, little has been done to ensure consistent implementation by ARIPO at the regional level. Since 2014 countless pharmaceutical patents have been granted by ARIPO that apply to Uganda.

According to the Ugandan patent office authorities, ARIPO has been notified of its national law, however this has done little to prevent ARIPO from granting pharmaceutical patents that extend to Uganda.

A similar situation prevails in other LDCs that are ARIPO members such as in Rwanda and Liberia whereby ARIPO patents are being granted inconsistent with national legislation. This situation creates legal uncertainty that could hinder the manufacturing or importation of affordable generic medicines.

Notably twelve out of the eighteen ARIPO members are LDCs: entitled to the pharmaceutical waiver. Exploitation of the LDC waiver is globally supported for its role in promoting access to medicines, and improving self-reliance through local/regional production. Yet ARIPO persist in granting pharmaceutical patents that extends to all LDCs, hindering manufacture, export and import of affordable generic medicines. 

Public health and legal experts say that ARIPO’s legal framework, the Harare Protocol requires urgent review and change in that it should be implementing the pharmaceutical waiver so that pharmaceutical patents do not apply to LDCs.

In 2017, the High-Level Meeting on Promoting Policy Coherence on Health Technology Innovation and Access in the ARIPO Region organized by the Government of Malawi as well as the 16th Session of the Council of Ministers of ARIPO also considered it to be critical to improve legal and policy coherence at the Regional level.

Accordingly, civil society across ARIPO Members have repeatedly called for implementation of public health sensitive TRIPS flexibilities in ARIPO. In June 2019, to move the issue forward, detailed proposals were presented to the ARIPO Secretariat.   

Despite this and the numerous promises made to civil society by the ARIPO Secretariat that it will engage on this matter, discussion on this important subject has been conspicuously absent. 

Given what’s at stake in Uganda, it should take leadership at the upcoming Administrative and Ministerial Meetings of ARIPO beginning next week to initiate a credible, transparent and inclusive process that includes civil society to review the Harare Protocol from a public health perspective and to explore implementation of WTO-TRIPS flexibilities in particular the pharmaceutical waiver that is imperative for public health.

Meaningful Youth participation

THERE IS NO WAY ANYTHING IS GOING TO BE DONE FOR THE YOUNG PEOPLE WITHOUT THEM BECAUSE IT WILL BE AGAINST THEM! (THE IMPORTANCE OF MEANINGFUL YOUTH PARTICIPATION)

I agree with World Contraception day ambassador Nana Abeulsoud when she states that today there are more young people than before and therefore youth voices matter because no one is more convincing to define the future through innovation but the largest population. It is common knowledge that Uganda has the second youngest population in the world with about 78% below 30 years and half of that below 15 years. We should also note the alarming growth rate which is 3% per annum, the unemployment rate of the youth which is 38% and the rate at which teenagers are getting pregnant has increased from 24% to 25%. It is on this premise that I focus on Adolescent girls and young women.  Adolescent girls and young women (AGYW), especially in sub-Saharan Africa, are highly vulnerable to HIV. In 2015, up to an estimated 450,000 new infections occurred among AGYW aged 15-24 years globally, translating into approximately 1,229 new infections per day.[1] In Uganda, where AGYW are estimated at 6,569,000 or 16% of the population, up to 29,640 infections occurred in 2015.[2] In 2014, HIV prevalence among young people aged 15-24 years was estimated at 3.72% for women and 2.32% for men.[3] New HIV infections among AGYW are substantially higher than among males of the same age because HIV is more commonly acquired from male sexual partners who are a few or several years older.[4] Findings from the Uganda AIDS Indicator Survey conducted by Ministry of Health revealed that 3% of adolescent girls 15-19 years live with HIV, and that prevalence doubles (7.1%) by the time they are 24 years.[5] Estimates for 2015 show that the country registered an estimated 83,000 new HIV infections, 22% of them among AGYW, among whom an average of 50 infections occurred on a daily basis.[6]

While carrying out research on integrating Legal Empowerment and Social Accountability (LESA) for Sexual Reproductive health and HIV services for Young People in Kibwa and Kireku slums, I realized that the biggest challenge these adolescent girls and young women face is lack of information. After being assured of confidentiality, some of them who had had children before 18 and had gotten infected wished they had known of contraception, what to do in case of coerced sexual activity and infection, redress mechanisms and what their rights as individuals are. INFORMATION. That’s what they basically wished they had. Most of them are brilliant with a lot of potential but have been derailed from what they could have been simply because they didn’t have this information.

I have interacted with these young people in our legal aid tents in a number of community outreaches and health and youth camps under different projects and the need cuts across. Some of the cases they report and some of the legal advice they seek is in regards to situations that would have been easily been avoided if they had the information they needed. At one of the most recent community outreaches in Mayuge district, I encountered a 21 year old girl who had had six children in six consecutive years simply because she did not know that she could say no to an early marriage as she was not coerced into it but also because she didn’t know of any family planning methods. This information should also be given to the parents of these young people as I have encountered parents that encourage some of this behavior by giving away their own children to be ‘married’ at a young age which is not right even if they have been defiled.

We therefore have to ensure that all the sexual reproductive health rights information is disseminated to the youth specifically in the hard to reach areas like the rural and slum areas but also involve them in decisions related to and for them. Also, young people need models and not critics like John Wooden said. Criticizing them for the past will not help improve the present and future situation. We should also have confidence in them and give them a chance to work with duty bearers as partners. Meaningful Youth Participation (MYP) means that young people work in all stages of decision-making and can participate on equal terms with adults at a number of levels, or alternatively work independently from adults and make decisions solely with the involvement of youth voices. MYP is a right that all young people have according to the Convention on the Rights of the Child. According to this UN Convention, young people have the fundamental right to participate and access information related to decision-making processes that affect their life and well-being. There is clear evidence that MYP benefits society, has positive effects on their development, strengthens organizational capacity and is key to achieving Sexual and Reproductive Health and Rights (SRHR) program outcomes. The youth should be encouraged to take charge of their lives by addressing their situation and then taking action in order to improve their access to resources and transform their consciousness through their beliefs, values, and attitudes. Policy and decision makers should also appreciate the benefits to the country of sufficiently investing in the young people and the risk/consequences to the country of not investing in their empowerment. Advocacy for SRHR enabling policy and social environment for adolescents and young people and empowerment of adolescents and young people to voice their rights and SRHR challenges that affect them should be intensified.

Since Adolescent girls and young women are the mostly affected as earlier illustrated, the Gender Transformative Approach (GTA) which actively strives to examine, question, and change rigid gender norms and imbalances of power as a means of achieving SRHR objectives, as well as gender equality objectives should also be applied. Male involvement and movements such as the ‘she decides’ movement which I am part of should also be encouraged so that we can have a world where every girl and woman can decide what to do with her body, her life and with her future WITHOUT QUESTION. And just Antonio Guterres (former secretary general of the United Nations) said, we need to place a special focus on young women and girls. So many futures are derailed when young women are pushed out of school, subjected to child marriage or have poor access to education and health care. When we empower Africa’s young women and girls, everyone wins.

The legal Empowerment and Social Accountability (LESA) approach will also go a long way in equipping the young people with the information they need and strengthen the capacity of Adolescent Girls and Young Women (AGYW) and their communities to demand for improved quality of SRH services for AGYW, including protection from sexual and gender-based violence (SGBV).

In a nutshell, youth voices matter because it is through that they can become fully empowered to become leaders in their own right. And for those in the struggle in the fight for the rights of the young people, there are times when you will see results in ten seconds and there are times you won’t see any for ten years. Either way, keep planting those seeds of character, eventually they will bloom.

Kyagera Nairuba Angella

Community Empowerment program (CEHURD)


[1] UNAIDS 2016 Estimates. Geneva: UNAIDS; 2016. (http://www.unaids.org/en/resources/documents/2016/HIV_estimates_with_ uncertainty_bounds_1990-2015 )

[2] PEPFAR. Uganda: DREAMS overview. https://www.pepfar.gov/documents/organization/253961.pdf

[3] Uganda AIDS Commission (2015). 2014 Uganda HIV and AIDS Country Progress Report

[4] UNAIDS 2016. HIV prevention among adolescent girls and young women: Putting HIV prevention among adolescent girls and young women on the Fast-Track and engaging men and boys. Guidance

[5] Ministry of Health (2011). Uganda AIDS Indicator Survey. http://health.go.ug/docs/UAIS_2011_REPORT.pdf

[6] Office of the President of Uganda (2017). Presidential fast track initiative on ending AIDS as a public health problem in Uganda; a five-point plan

Unresolved Maternal deaths

The Constitutional Court of Uganda on 30th September, 2019 formally heard Constitution Petition No. 16 of 2011. This case was filed in 2011 by the Center for Health Human Rights & Development & others against the Attorney General, challenging the unavailability of basic maternal commodities, the unethical conduct of health workers in public health facilities and failure of government to provide emergency obstetric care services among others.

On 2nd October, 2018, the President of the Republic of Uganda, His Excellency, Yoweri Kaguta Museveni officially commissioned the Mulago Specialised Women’s and Neonatal Hospital which was constructed to offer specialised services to women and children. On 18th September, 2018, Dr. Ruth Acheng, the Minister for Health made a ministerial statement on the operationalization of Mulago Specialised Women’s and Neonatal Hospital wherein she stated that there will be user fees charged for the services offered at the Hospital. The pay policy put in place categorised services offered at the hospital as Standard, VIP and VVIP services.  Furthermore, a waiver committee to determine who qualifies to access free services at the facility was to be put in place. This is an act of retrogression in the progressive realisation of the right to health and access to medical services. This prompted the Center for Health, Human Rights & Development to file Miscellaneous Cause No. 235 of 2019 against the Attorney General challenging inter alia the act of turning a public service into a private hospital at the Mulago Specialised Women’s and Neonatal Hospital.

It is over eight years since Constitutional petition No. 16 of 2011 was filed but there has been no redress from Court. Maternal deaths continue to happen in both public and private health facilities; some of these deaths are reported, others are concealed especially those happening in private health facilities.

In private health facilities, the vice is on rise leading to high maternal deaths; there are several instances of maternal deaths due to negligence and we highlight a few in this article. On 28th September, 2018, a mother admitted at St. Charles Lwanga Hospital in Buikwe District died along with her baby because of the hospital administration’s failure to refer her to another hospital for better management. The medical personnel supposed to attend to her were not on duty and the cashier tasked to provide the medical bill for payment before the discharge and referral of the mother was absent.

On 13th March, 2019, a mother lost her child at Alshafa Modern Hospital in Jinja District because the doctor supposed to attend to her reached the hospital late and the insistent requests by her to be referred to another facility were rejected. On 12th July, 2019, another maternal death occurred following the actions of a doctor at Butiru Chrisco Hospital in Manafwa District who failed to refer an expectant mother for better management because that referral would cause his hospital to lose funds which were being paid by USAID under the Uganda Voucher Plus Activity. On 20th October, 2018, a mother admitted to Kibuli Hospital underwent a cesarean section and spent over four hours in the theater; she was wheeled out of theater and placed in the ward while still unconscious. She was unattended to for more than 6 hours despite the fact that she was bleeding and eventually died.

These continuous maternal deaths raise the big question on who bears responsibility for all these deaths. Under Objective XX of the National Objectives and Directive Principles of State Policy of the Constitution of Uganda provides that the state shall take all practical measures to ensure the provision of basic medical services to the population.

The right to life is guaranteed under Article 22(1) of the Constitution of the Republic of Uganda. Clause 4 of the Uganda Medical and Dental Practitioners Council Code of professional ethics states that a practitioner shall not violate the human rights of a patient, the patient’s family or his or her caregiver. Furthermore, a practitioner is not to carry out any specific actions that constitute a violation of bill of rights enshrined in the Constitution of Uganda and international human rights law. Are health workers really aware about the provisions in the bill of rights or other international human rights laws in respect to health?

In Uganda, the health profession has many bodies that regulate the different medical professions; the Medical and Dental Practitioners Council is a body corporate established by an Act of Parliament – the Medical and Dental Practitioners Act, Cap 272 responsible for licensing, monitoring and regulating the practice of medicine and dentistry in Uganda. The Nurses and Midwives Council established by the Nurses and Midwives Act, Cap 274 mandated to train, register, enroll and discipline nurses and midwives of all categories in Uganda. The Allied Health Professionals Council is established under the Allied Health Professionals Act, Cap 268 mandated to regulate, supervise and control allied health professionals (Clinical officers). When a violation of human rights in respect to health particularly through medical negligence arises, complaints ought to be lodged with the appropriate bodies.

How then do these bodies that regulate the health profession and other stakeholders contribute to the reduction in maternal deaths in Uganda? The Uganda Law Society has partnered with the Uganda Medical Association in a number of activities for example on 30th August, 2019, the Uganda Law Society organized the first ever  Health Awareness Day for lawyers and invited the President of the Uganda Medical Association who came along with a team of doctors to speak to the lawyers that had gathered. This partnership is a strong partnership and an avenue for lawyers, medical professionals and other stakeholders to learn and embrace a human rights-based approach to tackling issues that arise in respect to the right to health.

The Ministry of Health is a key stakeholder in respect to health-related matters since it bridges the gap between the people and the medical profession since it supervises both government and private health facilities within the country.  Many public health facilities in the country have no medicines, basic services, no trained health workers to attend to people seeking health services including women seeking maternity services. In the absence of immediate intervention by medical professionals, the rates of maternal mortality continue to increase and issues surrounding maternal mortality are not addressed or resolved.

In light of the above, there is a wide gap that needs to be filled by different stake holders to fight this vice and reduce maternal mortality in Uganda so as to achieve social justice in health.

Namaganda Jane Kibira and Ajalo Ruth

Center for Health Human Rights and Development. (CEHURD)

Understanding Health and the Law

Health and the law is an emerging area of legal practice beset with a visible lack of national jurisprudence. The relationship between the law and health starts from the definition of the two terms; The World Health Organization (WHO) defines ‘health’ as a ‘state of complete physical, mental, and social well-being and not merely the absence of disease and infirmity’ and the law is defined as ‘the system of rules which a particular country or community recognizes as regulating the actions of its members and which it may enforce by the imposition of penalties’. The marriage of the two gives us Health and the law which refers to those enforceable laws established by government and applied to people for the purpose of building a healthy society.

In Uganda, health and the law did not exist as an independent area of practice until recently. It was largely embedded within the law of tort under medical negligence, constitutional law under quarantines for reasons of public health and safety and in criminal law under imposing sanctions on health workers for committing negligent acts. Health and the law has slowly garnered force in India and South Africa as seen in the 1998 case of Soobramoney v the Minister of Health (KwaZulu Natal), the Constitutional Court said that the government was justified in restricting access to kidney dialysis, because of the high cost of this type of care, and the need for the government to have reasonable plans for spending its health care resources.

In the 2002 case of Minister of Health v Treatment Action Campaign, the Court stated that the government was wrong to restrict access to the antiretroviral medicine, nevirapine, that is effective in reducing the risk of mother-to-child HIV transmission and ordered the government to make the medicine available to pregnant women living with HIV.

The principal legislation informing health and the law in Uganda is found in the Constitution of the Republic of Uganda, 1995 which creates an obligation on the State to ensure that all Ugandans enjoy opportunities and access to health services and ensure provision of medical services to the population. It can also be found in acts of Parliament which include the Public Health Act Cap 281, Insurance Act 6 of 2017, the Medical and Dental Practitioners Act Cap 272, the Nurses and Midwives Act Cap 274, the Allied Health Professionals Act Cap 268, Mental Treatment Act Cap 279, Venereal Diseases Act Cap 284, National Medical Stores Act Cap 207 and National Drug Policy and Authority Act Cap 206.

Health and the law has also seen a slow but sure growth in the courts of law where the Courts have set precedent in several cases such as the cases of Joyce Nakacwa vs. Attorney General Constitutional Petition No. 2 of 2001 which was unfortunately not heard on its merits, there is also Sarah Watsemba Goseltine and Baby David Goseltine vs. Attorney General High Court Civil Suit No. 675 of 2006 which discusses medical negligence. Medical negligence contributes to death, damage, injury of patients.

Although the legal framework provides for redress against medical negligence in form of civil and criminal law, these laws are inadequate because it is hard for a victim to prove medical negligence against a medical professional let alone extract payment of damages from the government.

The case of CEHURD vs AG Constitutional Petition No. 16 of 2011 challenges inter alia the non-provision of basic indispensable maternal health commodities in government health facilities but the Petition was struck out for raising political questions but this decision was overturned by the Supreme Court in Constitutional Appeal No.1 of 2013 and the petition was forwarded back to the Constitutional Court to be heard on its merits. On 30th September, 2019, the Constitutional Court heard arguments for and against this matter which was adjourned for a ruling which will be delivered on notice. There is also a growing connection between medical negligence and the right to health as seen in the cases of CEHURD & 3 ORS vs Nakaseke District Local Administration Civil Suit No. 111 of 2011 and CEHURD & 2 ORS vs Attorney General Civil Suit No. 212 of 2013 which discuss the right to health and medical negligence.

Health and the law has now expanded with the growing subscription to medical insurance and the increase of private actors in the health sector and some of the issues presented before Court now include; rights of persons with mental disabilities, tobacco control, sexual reproductive health, access to medicines, access to health information, quality of health care in private health facilities, businesses in the health sector among others.

There are also issues of professional misconduct/unethical behavior by health professionals, medical negligence, unhealthy and unsafe working environment in health facilities which jeopardize patient safety. The non-appreciation of the distinction between rights violations, ethics and medical negligence have also been prominent.

AJALO RUTH

ajalo@cehurd.org

Centre for Health, Human Rights and Development (CEHURD)

Mental health and young people

Suicidal behavior has existed throughout human history, but due to several complex factors, it has increased gradually in all parts of the world and, in the past few decades, has reached alarming statistical levels. Close to 800 000 people die due to suicide every year, this is one person every 40 seconds.

It is important to emphasize that it is a topic that has attracted the interest of most fields of study for centuries, which is why it has been explored by philosophy, religion, medicine, sociology, bioethics, law, and psychology, among other fields. It is often believed that it is only adults who exhibit suicidal behaviors, but it should be made known that many children and young people engage in this kind of behavior as a result of violence, sexual abuse, bullying and cyber bullying.

A student in his final year pursuing Medicine at Makerere University this year committed suicide for losing his savings from his first year over 15 million shillings. Well most of you are wondering why a university student in his final year can decide to commit suicide for just 15 million shillings, it is very possible. A lot of focus is put on the adults forgetting that young people too face psychological torture that can mentally perturb them. Assume this student had someone to talk to about this, maybe he would be among those that are to graduate. Let us help society learn about the signs and symptoms, risk factors and warning signs, and ongoing research about suicide and suicide prevention because the effects of suicide go beyond the person who acts to take his or her life: it can have a lasting effect on family, friends, and communities.

Suicide is a global public health problem that deserves the attention of all the actors in the field of mental health, including scientific and professional organizations, organizations for mental health users and their families, and universities. It deserves particular attention from government and national health authorities, since it is their responsibility to craft policies and directives aimed at establishing strategies to prevent suicide and promote the public’s mental health. Not leaving out the role of both print and audiovisual communication media and of social media, their participation can have positive as well as negative effects, depending on how they address this subject.

There are numerous complex factors that contribute to suicide, but what is most important is that all of our actions must be geared toward prevention. Accordingly, it is important that trans-sectoral and interdisciplinary action be taken by all of the actors involved.

Getting people to talk about a subject that tends to be a taboo and about which many hold mistaken and prejudiced ideas will help the community to learn about the risk factors so that they can identify and learn to address them.

Suicide is preventable and can therefore be avoided, which is why all of our efforts and public policies should focus on prevention. However, oftentimes, people who suffer from mental illness lack access to mental health services, sometimes because there are no services in their community and sometimes because they must wait months to be seen.

By: Faith Nabunya

Communication Associate at CEHURD