Health Breaking News 303

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 303

 

The Commission on Social Determinants of Health: Ten years after 

Are Big Companies Walking Their Talk on the SDGs? New report digs into the evidence 

International experts call out Austria for blocking progress on transparency for multinational corporation practices 

Unpacking Power and Knowledge in Global Health: some reflections from the Emerging Voices 2018 cohort 

The Cambridge Handbook of Public-Private Partnerships, Intellectual Property Governance, and Sustainable Development 

Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab 

Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection 

Brazil Signs Deal With Medicines Patent Pool To Share Patent Information 

Unitaid ranked as one of the world’s leaders in funding tuberculosis R&D 

World leaders commit to bold targets and urgent action to end TB 

World Leaders Commit To End Tuberculosis At Historic United Nations Meeting 

MSF response to first-ever UN tuberculosis summit 

UK pledges funding to speed up TB treatment 

Variations in the quality of tuberculosis care in urban India: A cross-sectional, standardized patient study in two cities

UN High-Level Meeting On Noncommunicable Diseases: A Call To Action

Costs and cost-effectiveness of HIV/noncommunicable disease integration in Africa: from theory to practice 

DRC Ebola latest numbers as of 25 September 2018 

DR Congo Ebola outbreak: Beni attack halts outreach work 

WHO Extremely Concerned About Ebola ‘Perfect Storm’ in Congo

Push to contain Zimbabwe cholera outbreak ahead of rainy season 

Fixed-dose combination therapy for cardiovascular disease: what can we learn from HIV? 

DNDi: Responding to neglected patients’ needs through innovation 

11th DNDi Partners’ Meeting: From innovation to access in Africa – the way forward 4 October 2018 Kampala, Uganda 

India Uses Tech to Power its New Battle Against Malnutrition 

Without Food Security, There Is No Peace 

How Filling in the Agricultural Data Gap Will Fill Empty Plates 

Why do women still die giving birth? 

UN Chief Blasts Lack of ‘Strong Leadership’ on Climate 

Climate action held back by conflicting policy in African countries 

Europe’s 2050 climate strategy takes shape 

What a Waste: An Updated Look into the Future of Solid Waste Management 

Uganda: the Big Challenge of Maternal and Child Health

Uganda has made progress towards improving the health of children, newborns, adolescent boys and girls, women and men in the country. However, Uganda  still ranks among the top 10 countries in the world with high maternal, newborn and child mortality rates. Many policies have been implemented over the last 20 years trying to improve maternal and child health. The related health indicators are progressing but there is still much to do

By Pietro Dionisio

 EU health project manager at Medea SRL, Florence, Italy

Degree in Political Science, International Relations Cesare Alfieri School, University of Florence, Italy 

Uganda: the Big Challenge of Maternal and Child Health

 

Over the past two decades, Uganda has made progress in improving Reproductive, Maternal, Newborn, Child and Adolescent Health (RMNCAH) indicators. Nevertheless, RMNCAH conditions currently account for over 60% of years of life lost in Uganda constituting a major public health problem. Maternal mortality rates fell by only 20% over the past 20 years, decreasing too slowly to achieve national targets. The unacceptably high number of maternal deaths annually are mainly caused by hemorrhage, obstructed labor and complications from abortion and account for 2% of the annual maternal deaths globally. Moreover, almost 28% of maternal deaths occur in young women aged 15 – 24 years.

Actually, Uganda realized a steady reduction in child mortality rates between 1995 and 2016 from 156 to 64 per 1,000 live births with the annual rate of reduction increasing dramatically from 1.2% per year to 8.1% per year between 2006 and 2011. Unfortunately, while the infant mortality rates have followed a similar trend, neonatal mortality is decreasing at a slower pace with newborns experiencing a disproportionate burden of deaths among this age group. Under-five mortality is mostly attributable to neonatal conditions as well as three common childhood illnesses: malaria, pneumonia, and diarrhea often in synergy with underlying malnutrition.

The path is still long and a lot has to be done to reach the SDGs target by 2030. As such, according to the “Reproductive, Maternal, Newborn, Child and Adolescent Health Sharpened Plan for Uganda 2016/17 – 2019/20”, the Government is addressing the following topics:

  • Improving maternal mortality (including improvement of skilled birth attendance and antenatal care),
  • Improving adolescent health,
  • Family planning,
  • Ending preventable newborn and under-five mortality,
  • Improving Universal Health Coverage (UHC),
  • Provision of water and sanitation,
  • Coverage of RMNCAH Interventions, &
  • Malnutrition reduction.

But, how these dominions are treated? What about the outcomes of government directions so far?

As for the first point above, the maternal mortality has dramatically improved. Indeed, it has gone down to 336 per 100,000 live births (687 per 100,000 in 1990). The skilled birth attendance and the antenatal care are being improving, but great disparities persist between urban and rural areas as well as between educated mothers and the non-educated ones. In fact, while skilled attendance at birth rate is 89% in urban area, it is just 53% in the rural zones. Additionally, only 38% of mothers with no education had a skilled attendant at birth, compared to 55% of mothers with primary education and 93% with higher education.

Likewise, things aren’t going well if we consider “adolescent health”. Indeed, Uganda still has one of the highest rates of adolescent pregnancy and HIV incidence among young people in Sub-Saharan Africa. Overall, teenage birth rate or proportion of births per 1,000 women aged 15-19 years decreased from 204 to 111 between 1995 and 2016 with 24% giving birth to their first child before turning 19 years. Additionally, adolescent women are loath to use sexual and reproductive health services because of long waiting time, long queues, and poor quality services. Plans have been implemented and guidelines released (“Adolescent Health Policy Guidelines and Service Standards 2012”) to overtake this situation, but only slow pace progresses are obtained and more efforts should be devoted to adolescents’ health and related strategies.

Concerning family planning, overall, 39% of currently married women are using a method of family planning. Furthermore, the contraceptive prevalence rate among married women generally increases with age, peaking at 40-45 years old women (47%) before declining to 29% among women aged 45-49. Women with no education are less likely (26%) than women with any education (38-51%) to use a contraceptive method. Concerning sexually active unmarried women, 51% are currently using a contraceptive one.

Noteworthy, Uganda is moving towards Universal Health coverage (UHC) and a higher RMNCAH coverage. In fact, the Country has a strong health sector development plan that seeks to, among other goals, “accelerate movement towards UHC with essential health and related services needed for promotion of a healthy and productive life”. Additionally, a health sector monitoring and supervision framework has been set up and health services have been deployed both at national and local level.

Unfortunately, despite strong policies foundation, still a long way has to be covered to achieve UHC. At a time when  72% of the Ugandan population live within 5 km of a health facility, only 13% of health facilities carry out scheduled maintenance of medical equipment, while health workforce density is at 1.55 per 1,000 population and health facilities reporting availability of over 95% of a basket of commodities are only 55%.

What’s more, despite the presence of important and well-articulated programs, the water and sanitation sector is still a little bit tricky for the Country. In fact, almost 61% of Ugandans lack access to safe water and 75% do not have access to improved sanitation facilities.  Many are the reasons explaining this state of the art, but the development of the socio-demographic fabric as well as the lack of good and prompt infrastructure are among the most relevant. In fact, since mid-‘90s, Uganda experienced a significant economic growth, leading to large population movements from rural to urban areas. Additionally, the high population growth, coupling with an inadequate infrastructure development, stressed the existing water and sanitation services. Many initiatives are currently on the ground to improve the situation. Among these, the last June, the African Development Bank approved a $62 million concessional loan to finance the Ugandan “Strategic Towns Water Supply and Sanitation Project (STWSSP)”. The project, to be implemented in 10 towns spread across the country over a five-year period, is designed to enable the government to achieve sustainable provision of safe water and sanitation for the urban population by 2030.

These prospects unfortunately couple with the awareness that RMNCAH plan is undermined by a high rate of women abuse cases. The 2016 Uganda Demographic and Health Survey revealed that up to 22% of women aged 15 to 49 in the country had experienced some form of sexual violence. The report also revealed that annually 13% of women aged 15 to 49 report experiencing sexual violence. This translates into more than 1 million women exposed to sexual violence every year in Uganda. Violence against women has recently taken new, more sophisticated forms. An increasing number of women are, for instance, reporting cyber-bullying and abuse through social media and smartphones.

In particular, ineffective laws pose a big challenge to the fight against women abuse. Laws such as the Penal Code (Amendment) Act 2007, the Domestic Violence Act 2010, the Sexual Offences Bill and the Marriage Bill do not address key violence against women. None of these laws criminalize marital rape, for instance. The Domestic Violence Act does not cover cohabiting partners, while the 2004 amendment to the Land Act of 1998 requires spousal consent to sex, but does not recognize coownership of land between spouses. The Land Act also fails to require customary land tenure systems to permit women to act as co-owners/managers of customary land, and creates weak protections for widows who seek to inherit their husband’s land. Additionally, the Employment Act, 2006 restricts punitive action in sexual harassment cases at work to an employer or his representative, saying nothing of physical, sexual and verbal abuse by coworkers.

Poor funding for “stop violence against women” programs also remains a huge challenge.

Things are not running well for malnutrition as well. As a malnutrition consequence, almost one-third of children under 5 years in Uganda are stunted. Stunting increases with age, peaking at 37% among children 18-35 months with a higher prevalence among children in rural (30%) than urban (24%) areas, with some regional variations. Unfortunately, more than 30% of the total population faces some level of chronic food insecurity. The causes of food insecurity in Uganda are multifaceted, often as a result of poverty, landlessness, high fertility, natural disasters, high food prices, lack of education, and the fact that a majority of Ugandans depend on agriculture as a main source of income. Gender inequality worsens food insecurity and poverty.

Admittedly, the Government is fighting this issue and several programs have been implemented (such as the  “Uganda Nutrition Action Plan (UNAP)” or the “National Nutrition Planning Guidelines (2015)” and the “Multi-Sectoral Nutrition Action Planning Training Module (2017)”), but more has to be done to reach the national targets in this area.

To conclude, gender equality is not only a fundamental human right, but a pre-condition for sustainable development. Providing women and girls with quality education, health care, decent work, access and ownership rights over property and technology, and an equal participation in political and economic decision-making processes will lead to social, economic and environmental sustainability across the globe.

Uganda is strongly progressing in the protection of women and girls, yet a lot remains to be done. As a matter of fact, at a time when RMNCAH indicators are improving year by year and investments in the sector are growing nationwide and internationally, the overall healthcare and law system is not strong enough to underpin them.

Nevertheless, while discrepancies between what is written and the reality are still huge and time is needed to make further progress, the road is seemingly traced to achieve the foreseen targets by 2030.

 

Health Breaking News 302

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 302

 

WHO Releases Draft Roadmap For Access To Medicines; Comments Show Polarised Views 

Commitment to Development Index 2018: Europe Leads the Way 

CDI 2018 and Trade: Advanced Economies and Poverty-Weighted Trade Tariffs 

The Cambridge Handbook of Public-Private Partnerships, Intellectual Property Governance, and Sustainable Development – New Publication

Thumbs up or thumbs down? Did the Millennium Villages Project work? 

Draft UN non-communicable diseases (NCDs) Declaration, Sept 18 version 

UN agrees global plan to battle TB ahead of first-ever summit 

WHO calls for urgent action to end TB 

MSF response to release of WHO’s Global Tuberculosis Report 2018 

Ebola situation in DRC: Latest numbers as of 18 September 2018 

WHO working closely with Republic of Korea on response to MERS case 

Is This the End of Polio? Rotary Hangs in to Eradicate the Disease Once and For All 

SDG 3.3 on HIV – A noble target with a dangerous blind spot 

Zimbabwe: Govt Declares War on Cholera 

Birth defects cluster not just down to Zika 

Misconceptions and paradoxes in soil-transmitted helminthiases control as a public health problem 

A big, fat, complicated public health problem 

Drug industry reacts to Oxfam’s allegations of tax-dodging 

‘Falsified and Substandard Medicines: Threat to the SDGs – but Who’s Watching, Caring or Acting?’ by David Patterson 

Ocean advocates find new ways to link their cause with climate change 

Philanthropy Finds a Major Role at the Global Climate Action Summit—Inside and Outside 

Securing community forest rights is key to achieving climate goals 

Charities pledge nearly $500M against deforestation 

10 years to ditch fossil fuel car engines, save Paris climate target, warns study 

UNPO Hmong Newsletter September 2018 

What Is Illiberal Civil Society? 

The other Rohingya crisis 

PEOPLE’S HEALTH MOVEMENT: A CALL TO ACTION ON NUTRITION, FOOD SECURITY AND FOOD SOVEREIGNTY  

CVS To Restrict Patient Access Using Cost-Effectiveness: Too Much, Too Soon 

Despite Progress Under The ACA, Many New Mothers Lack Insurance Coverage 

Nigeria: ‘More People Have Access to Phones Than Toilets in Nigeria’ 

 

 

 

 

 

 

 

Falsified and Substandard Medicines: Threat to the SDGs – but Who’s Watching, Caring or Acting?

Falsified and Substandard (FS) medicines remain a largely hidden problem in many lower-and-middle income countries. Adding to law reform, a comprehensive response should include strengthening of capacity, accountability, collaboration and coordination of all concerned parties

By David Patterson*

Principal Consultant, Health, Law and Development Consultants (HLDC), The Hague, Netherlands

Falsified and Substandard Medicines: Threat to the SDGs – but Who’s Watching, Caring or Acting?

 

The heartfelt cry for action on falsified (‘counterfeit’) and substandard (FS) medicines in Uganda by Denis Bukenya and Michael Ssemakula on PEAH – Policies for Equitable Access to Health in August and September 2018 must not be ignored.

FS medicines remain a largely hidden problem in many lower-and-middle income countries – legitimate manufacturers are afraid of a loss of confidence in their brands – and hence loss of revenue, governments fear censure if the scale of the problem becomes widely known, and there has been deliberate obfuscation between deadly FS medicines and quality generic drugs that can save lives. International development agencies have generally focused on technical solutions without addressing the transnational criminal aspects.

In 2015, with funding from the World Bank, I led a multi-agency team for the International Development Law Organization (IDLO) on a scoping mission to Kampala to review options to strengthen the legal environment for the elimination of FS medicines. Our report was published in February 2016 on the websites of IDLO and of the World Bank’s Global Forum on Law, Justice and Development.

Our recommendations focused less on law reform and more on strengthening the capacity of the different actors, including civil society. Uganda has a relatively vibrant civil society sector. Many NGOs focus on health, and several have addressed issues related to FS medicines. However, the civil society response to the issue of FS medicines is complex. It was reported that in some districts local populations may wish to protect unlicensed vendors from inspectors by informing the vendors of upcoming inspections. This occurs because the local population is afraid that the unlicensed vendors will be closed and drugs will be less accessible. They do not adequately understand the dangers of FS medicines.

We therefore identified civil society capacity as central to strengthening government resolve to act. This would mean supporting health rights organizations such as the Centre for Health, Human Rights and Development (CEHURD) as well as the Community Health and Information Network and the Coalition for Health Promotion and Social Development.

We also heard that regulators and prosecutors needed training to prosecute for crimes relating to FS medicines, and that magistrates and judges may need training to ensure that the full gravity of the offences are understood, and appropriate penalties imposed.

We approached multiple funders for support to implement the recommendations of the scoping mission, but failed to elicit any interest. The justice sector funders told us to approach the health sector donors, and vice versa. Development sector funding to build public health law capacity typically falls in the crack between the silos of justice and health. Some donors, such as Open Society Foundations and the Ford Foundation, understand this general problem. But their support cannot respond to the scale of the need – the response must be mainstreamed.

As noted by Bukenya and Ssemakula, the impact is both on infectious and non-communicable diseases (NCDs). On 27 September 2018 the United Nations General Assembly will reflect on the sporadic successes and multiple failures of its Member States to address NCDs since 2011. While the focus will largely be on prevention, the draft resolution circulated on 27 July also includes welcome commitments to improve ‘access to access to safe, affordable, effective and quality essential diagnostics, medicines, vaccines and technologies…’ There were also specific references to drugs to treat cancer and mental illness.

The draft resolution also includes commitments to strengthen legislative measures to address NCD risk factors. But the challenge of FS medicines, which threatens to undermine all efforts to achieve the health-related Sustainable Development Goals (SDGs), is not on the agenda.

* Disclosure: From 2009 – 2018 David Patterson was senior legal expert, health, for the International Development Law Organization (IDLO). He is now a consultant with IDLO and other health,law and development organizations. Correspondence: dpatterson@healthlawdc.com

 

References (chronological)

Denis Bukenya and Michael Ssemakula, The Untold Story About Counterfeit Medicines And Its Effects On The Right to Health In Uganda published on PEAH 10 September 2018 available at http://www.peah.it/2018/09/the-untold-story-about-counterfeit-medicines-and-its-effects-on-the-right-to-health-in-uganda/

Denis Bukenya and Michael Ssemakula Accessibility to Medicines in Uganda published on PEAH 24 August 2018 available at http://www.peah.it/2018/08/accessibility-to-medicines-in-uganda/

Strengthening the Legal Environment for the Elimination of Falsified and Substandard Medicines: Uganda Report (2015: IDLO, UNICRI, O’Neill Institute, World Bank) available at http://www.globalforumljd.com/sites/default/files/docs/cop/160215%20FS%20medicines%20Uganda%20report%2015%20February%202016%20low%20res.pdf and at https://www.idlo.int/what-we-do/initiatives/uganda-report-strengthening-legal-environment-elimination-falsified-and

Health Breaking News 301

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 301

 

News from TDR Director, John Reeder 

Bloomberg School Program Awarded $20.5 Million From Bill & Melinda Gates Foundation To Focus on Urban Youth and Reproductive Health 

KEI statement: Informal Discussion of the WHO Roadmap Report on Access to Medicines and Vaccines 2019–2023 

Brazilian Supreme Court Refuses To Judge Its Biggest Case On IP And Access To Medicines, And Benefits Big Pharma With Undue Monopolies 

MSF response to ruling in Gilead sofosbuvir patent hearing at European Patent Office 

Civil society groups call for end to Gilead’s unwarranted hepatitis C drug monopoly in Europe 

‘The NHS Postcode Lottery: How the Decision-Making Power of Clinical Commissioning Groups is Preventing Standardised, Equal Access to the Abbott Freestyle Libre in England’ by Rebecca Barlow-Noone 

Opinion: Why diabetes in pregnancy should be on the agenda at UN meetings 

Extended Monopolies On Biologic Drugs – A Warning To Developing Countries 

11th DNDi Partners’ Meeting: From innovation to access in Africa – the way forward 

DNDi: 2017 annual report ‘Responding to Neglected Patients’ Need Through Innovation’ 

‘The Untold Story About Counterfeit Medicines And Its Effects On The Right To Health In Uganda’ by Denis Bukenya and Michael Ssemakula 

Salute spa, il nuovo libro che racconta il “delitto perfetto” in atto sulla sanità pubblica tra politica e assicurazioni 

Ebola in DRC: Latest numbers as of 12 September 2018  

Zimbabwe Declares Cholera Emergency as Disease Spreads in Capital 

Burden of leishmaniasis in Brazil and federated units, 1990-2016: Findings from Global Burden of Disease Study 2016 

The Impact of Civil Conflict on Child Malnutrition and Mortality, Nigeria, 2002-2013 – Working Paper 494 

Breastfeeding in low-resource settings: Not a “small matter” 

Global hunger increasing, UN warns 

Hunger as a weapon ‘on the rise’ in warzones 

Human Rights Reader 459 

10 years on: Global debt at all-time high. Developing countries hit hard by fallout 

UN Human Rights Council Begins; Freedom Of Expression Issues Highlighted By Article 19 Group 

Rohingya crisis: one year on 

‘Caning of LGBT Persons – Implications for Public Health and the Economy’ by Fifa Rahman 

“A Dysfunctional Market.” What This Foundation is Doing to Control Healthcare Costs 

Former Wall Street Banker Who Advanced the Cause of Women & Children in Africa 

12 Things We Can Agree On about Global Poverty 

Local Action: Where Can Climate Funders Make a Difference in the Age of Trump? 

Rich Nations Vowed Billions for Climate Change. Poor Countries Are Waiting 

Estimate of carbon in indigenous lands rises five-fold 

Caning of LGBT Persons – Implications for Public Health and the Economy

This article draws on the significant amounts of rejection, threats of violence, and stigmatisation faced by LGBT Muslims, with a focus on implications for public health and the economy

By Fifa Rahman*

Postgraduate Researcher (PhD) at University of Leeds, UK

Caning of LGBT Persons

Implications for Public Health and the Economy

 

In the placental excreta of the recent Malaysian elections and a new government built on promises of justice and good governance, there has been increasing hatred and corresponding human rights violations towards LGBT (Lesbian, Gay, Bisexual, Transgender) people, perhaps as an overreaction to the perception that human rights would destroy religious privileges. This began with the removal of portraits of notable Malaysian LGBT activists from an art gallery in the island state of Penang, to viral tweets from extremists quoting hadith allowing for the murder of LGBT persons, and this past week has culminated in the caning of two young Muslim women for ‘attempting lesbian sex’. A gay friend of mine sent me a message on Facebook saying that his parents were part of the 100 people who witnessed the caning. Malaysian twitterverse is rife with thousands of tweets from average people saying that the caning was ‘gentle’, that there was no humiliation, and that it was a victory for Islam.

But is it really?

A victory for any group of persons should be seen in the light of economic stability, an improvement in public health, and an improvement in happiness. The public health implications first. Recent literature details how LGBT Muslims face significant strain and anxiety in reconciling their faith with their sexuality – some individuals feel aberrant, that their sexuality taints Islam, and that their sexuality is a test from Allah (Eidhamar 2014; Siraj 2012). In an analysis of British Muslim gay men, Jaspal and Cinnirella (2010: 855) write, “The dilemma lies in individuals’ perception that being gay is in some way ‘wrong’ or illicit, but that, on the other hand, it is God who has created them ‘this way’.” One scholar has suggested that in order to remedy this conflict, LGBT Muslims should resort to an alternative pedagogy of Islam (Shah 2016). Alternative interpretations aside, the fact remains that LGBT Muslims, in addition to internal conflicts of reconciling their faith with their sexuality, face significant amounts of rejection, threats of violence, and stigmatisation that negatively affects mental health.

LGBT people with mental health conditions are also notoriously difficult to reach. As Lucksted (2004: 27) writes, “LGBT people with serious mental illnesses are difficult to reach and to measure, given the multiple stigmas of psychiatric labels, LGBT identities, and the poverty common in the lives of people receiving services in the public system.” These compound existing difficulties faced by mental health staff in tackling an increasing public health burden.

LGBT Muslims are politicians, corporate executives, nurses, lawyers, waitresses, and soldiers.

When workers struggle with a lack of acceptance, anxiety, and depression, this in turn affects the economy. In a review in the United Kingdom, mental health issues in the workplace cost the UK economy £34.9bn in 2017. A study from Canada estimated that total economic costs associated with mental illness would increase six-fold over the next 30 years, exceeding $2.8 trillion (Doran and Kinchin 2017).

There is no doubt that a fervent conservative would respond to this article with ‘just don’t be gay’, and thus no mental health issues and no economic impact. But they forget the decades of cruelty of failed conversion therapies in other nations. Truly, to quote a line attributed to an array of authors, “Those who cannot remember the past are condemned to repeat it.” Homophobia and transphobia is an urgent human rights and public health issue – diplomatic measures must be deployed with greatest urgency to mitigate the burden.

 

*About the Author

Fifa Rahman LLB (Hons) MHL (Health Law) (Sydney) is a PhD Candidate in Law at the University of Leeds. She also represents NGOs on the Board of Unitaid, working on access to innovative health technologies in HIV, tuberculosis, and malaria.

 

 

 

 

 

 

 

 

 

 

 

The Untold Story About Counterfeit Medicines And Its Effects On The Right To Health In Uganda

Uganda's National Drug Authority (NDA), a national body that presides over the oversight and authorization of sale and distribution of drugs, does not have a National Formulary (NF) to outlaw and disallow importation of counterfeit drugs. This paper raises many questions relevant to drug authorization in Uganda and calls for response to the unresolved answers: What does NDA use to guide and control the marketization and selling of imported drugs in Uganda in the nonexistence of a National Formulary? What does NDA use to make a taxonomy between unauthorized and authorized drugs for general public use?

By Denis Bukenya

and Michael Ssemakula

Human Rights Research Documentation Center (HURIC), Kampala, Uganda

The Untold Story About Counterfeit Medicines And Its Effects On The Right To Health In Uganda

 

If the dead had an opportunity to voice out their very last second-chance entreaties and wishes, their Grade-A wish would be to return to the mortal world and lay-grab of the devious fake drug sellers and the lazy buyable and corrupt incompetent drug regulators in Uganda. Everybody desires to live a long-life free from disease. Therefore, selling one a counterfeit drug is undeniably an ill-timed death terminal condition given to a patient to find his/her treatment from the defunct immortal world of the deceased.

It is an unendurable obnoxious shockwave to return to the medic for approval of the medicines you purchased at astronomically sky-high price from a health facility or pharmacy and s/he announces in your two earholes, that the medicines you bought don’t exist anywhere in the medicine bracket to cure your illness. If this happens to you, for while your individual-self can half -way pass-on after hearing the vulgarity loutish of this statement. Apparently this has grown into a wide abnormal-normalized deceptive sound lyric which Ugandans’ ears have conventionally and strongly got accustomed to. The outrage is seemingly spinning and bleeding the patients’ undying agony into an eternal psychological and financial hemorrhagic pain. The predicament is spiraling by-day due to the shocking and severely nerve-wracking flooded pond of fake and unregistered medicine drugs sold on the medicine market. This health firetrap has not seen any light of cure yet and no ultimate remedy in the policy space has been forthrightly fronted towards assisting those scammed through counterfeit medicines by the crooked and dishonest drug merchants.

The National Drug Authority (NDA), a national body that presides over the oversight and authorization of sale and distribution of drugs, does not have a National Formulary (NF) to outlaw and disallow importation of counterfeit drugs. The NF comprises a list of drugs that are permitted for medical prescriptions all-over the Country, but this is non-existent thus exposing multitudes to an unescapable eminent death endangerment. The National Drug Authority Act under Section.8 (2) & (3) requires NDA (NDA, 2000) to make sure that the country has a NF and it further provides that “no person shall import or sell any drug unless it appears on the National Formulary.” This NF similarly encircles significant information evidence on the description, composition, selection, recommendation, prescription, administration and dispensation of medicines, which has not been considered yet. Shamefully, the NDA Act was approved and passed in the year of 2000, but unfortunately the Formulary has not been established yet into reality to help the citizenry.

In the article on fake medicines (Aine, 2018), the ex- interdicted legal advisor of the NDA, Mark Kamanzi revealed that, despite the fact that the NDA is aware of National Formulary would favor Ugandans; they chose to “illegally” use a register which they can control. This paper raises many bold questions and a call for response to the unresolved answers:

What does NDA use to guide and control the marketization and selling of imported drugs in Uganda in the nonexistence of a National Formulary?

What does NDA use to make a taxonomy between unauthorized and authorized drugs for general public use?

This is a geometrically growing trend of counterfeit pharmaceuticals far-and-wide recognized as a public health threat and a serious concern to the health advocates, researchers, consumers and public health officials. According to the World Health Organization reports, in many countries counterfeit prescription drugs cover as much as 70 percent of the drug stock supply and have been accountable for the legions of deceases in the world’s most impoverished nations. In 2016, a report by newz Ug (Ug, 2016), after the fake malaria medicine distribution and consumption, the  NDA warned against  a counterfeit malarial drug Coartem with the Green Leaf AMFm wallet packs that is found on the market with pack details Batch number NOF 2153, Date of manufacture: 062015,Expiry Date 07 2018. Further in the recent past, the NDA approved the selling of Valsartan drug used in the treatment of high-blood pressure, usually in combination with other anti-hypertensive drugs. However, on Thursday 16th August 2018 (NDA M. , 2018) NDA recalled the drug after its distant-wide distribution on the market justifying that they had discovered some brands of this drug were manufactured using an ingredient potentially contaminated with an  impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen (a substance that could cause cancer). Now these drugs for way too long have been sold on the market, so, who did authorize them? Why does NDA wait every passing year to do a regulatory scrutiny and research on risky medicines such as Valsartan and fake Coartem  after procuring them and distributing them to the public for health treatment? The patients who took these medicines, were they diagnosed to establish the status of the Valsartan and fake Coartem’s effects on their health? Was the awareness information broadly enough disseminated to help the vulnerable patients who had already subscribed to the deathtraps of these drugs? Were the patients compensated for the financial losses incurred through buying these fake drugs? The absence of a Formulary now clearly justifies the rapidly increasing number of fake drugs in the health centres, drug shops and pharmacies. Additionally to the pharmaceuticals, medical devices and other medical-related products are also faked, comprising blood-glucose, spectacles’ contact lenses, test strips, surgical and clinical instruments, and even sexual reproductive commodities like condoms and pills.

Research shows counterfeit drugs often comprise inappropriate quantity of active substances or no active substance at all. In long-run, through use of counterfeit drugs, illnesses’ prevalence continues untreated which results in treatment failure, amplified resistance to treatment, and even may cause death, thus intercepting people’s right to proper health. Many counterfeits have inactive pharmaceutical ingredients — they comprise ineffective ingredients, these ingredients contain chalk, flour, vitamins, talcum powder, or sugar, which, when taken with an anticipation of having a pharmacological effect, can be deadly.

There are numerous factors that raise opportunities for counterfeit drugs to continue their soundless existence in the medicine market which include deficiencies in supply, monitoring mechanism and legislation (counterfeit laws and policies):

– Supply and procurement related concerns that consist of irregular stock of pharmaceutical commodities due to a void in the forecasts and health strategic plans leading to stock-outs thereby creating a vacuity that counterfeit merchants start to fill.

– The vacuum in the legislation and monitoring of the drugs in pharmacies, health centres and drug shops are vehicles fuelling and incentivizing the prevalence of counterfeit medicines. In that counterfeited stuffs pass through the procurement and eventually the supply chain undistinguished and undetected, and even when noticed, there are inadequate and unsatisfactory legal mechanisms to indict those implicated. Therefore with a deficiency in effective and operational mechanism to monitor the supply sequence, the challenge can only deteriorate.

– Management and handling of drugs by inexperienced and untrained health personnel in medicine outlets, this correspondingly increases chances for counterfeit drugs because numerous indicators of counterfeit drugs necessitates generic medicine knowledge and understanding of the technical pharmacological interpretation before the dispensation of the medicines to the public.

In our proposed recommendations therefore, The Government should re-consider strengthening The Anti-counterfeiting Goods Bill, 2015, (Watch, 2015). This bill in Section 10 provides for confiscation and imprisonment of the person indicted and found guilty of the counterfeiting crime; the Bill in general goes on to provide for return of the counterfeit items to the country of origin; however, more emphasis should be put on withdraw of licenses from the importers as an ultimate solution to reduce the vice.

Relevantly, the ongoing and devastating growth trend of the fake drugs has heavily been caused by the lazy and incompetent regulators who have intentionally continued to use the national drug register instead of the National Formulary (NF). The absence of a Formulary undoubtedly vindicates the ever persistent increasing number of fake drugs in the health centres, drug shops and pharmacies.

Stringent assessment, monitoring, usage and clearance of drugs are called for to reduce the delay in identification of counterfeits. In most cases the drugs are discovered to be fake after when they have hit the market and consumed by the population. Therefore proper assessment and monitoring of the medicine supply chain stages should be emphasized before the final drug usage.

Distribution of drugs in the licensed pharmacies and health centres should be done by an authorized, qualified and well trained health practitioner. This is because many medicines in the drug outlets are handled by untrained health personnel who literally have very little generic medicine knowledge and understanding of the technical pharmacological interpretation for the public.

 

Bibliography

Aine, K. (2018, April 25). Uganda Drug Authority Lacks Manual to Block Fake Medicine. Kampala, Central, Uganda.

Jaramogi, P. (2011). Fake drugs flood Kampala. Kampala: New vision.

NDA. (2000). THE NATIONAL DRUG POLICY AND AUTHORITY ACT. Kampala: NDA.

NDA, M. (2018, August 16). Recall of Valsartan a drug used in the treatment of high blood pressure. Kampala, Central, Uganda. Retrieved from National Drug Authority: https://www.nda.or.ug/ug/dnews/133/Public-Notice—Recall-of-Valsartan-a-drug-used-in-the-treatment-of-high-blood-pressure-.html?option=dnews&id=133

Ug, n. (2016, October 13). Shock as National Drug Authority recalls six fake drugs. Kampala, Central, Uganda.

Watch, P. (2015, October 16). The Ant-Counterfeiting Goods Bill, 2015. Kampala, Central, Uganda.

 

 

Health Breaking News 300

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

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The NHS Postcode Lottery: How the Decision-Making Power of Clinical Commissioning Groups is Preventing Standardised, Equal Access to Abbott FSL in England

Using the example of access to FSL glucose monitoring system, this report aims to highlight the fundamental problems with localist decision making on healthcare provision in England where the existing system of devolved power to Clinical Commissioning Groups is promoting a landscape of unequal access to medical care

By Rebecca Barlow-Noone *

Student of Medical Sciences at the School of Biological Sciences, University of Leeds (UK)

The NHS Postcode Lottery: How the Decision-Making Power of Clinical Commissioning Groups is Preventing Standardised, Equal Access to the Abbott Freestyle Libre in England

 

The existing system of devolved power to Clinical Commissioning Groups (CCGs) is promoting a landscape of unequal access to medical care across the country, as demonstrated by recent media coverage regarding the flash glucose monitoring system, the Freestyle Libre (FSL). Demands must be made to address the unnecessary multi-tiered system of nationalist and localist decisions on NHS healthcare provision, which is impeding equality of care in England.

To understand the heart of the problem, the creation of CCGs must be understood. CCGs were established to realise demands made under the Health and Social Care Act of 2012 by allowing more localist decision making on healthcare provision and budgeting, in relation to Liberal Democrat ideology (The King’s Fund, 2013); yet this is a case where political ideology has overridden the true needs of the NHS.

Whilst localism appears progressive by enabling (in theory) the needs of local people to be prioritised, the responsibility devolution to CCGs has allowed healthcare to become non- standardised across England. With 207 separate decisions on access to healthcare and medicines, it was inevitable that a healthcare postcode lottery would emerge; and due to media coverage of FSL access, the issue is finally coming to light to the public.

Using the example of access to FSL, this report aims to highlight the fundamental problems with localist decision making on healthcare provision.

Firstly, responsibility devolution to CCGs causes multiple duplications of evaluation in items without NICE (National Institute for Health and Care Excellence) recommendation. The FSL, which became available on the NHS drug tariff in November 2017 through the NHS Business Services Authority (BSA), still lacks a Technology Approval (TA) from NICE. Without a TA, which legally binds CCGs to prescribe the technology according to NICE guidelines, CCGs are able to decide if the FSL can be supported on the budget in their area.

Responsibility devolution to CCGs has led to them becoming ‘the dominant operational unit within the NHS’ (Speed and Gabe, 2013, 571), where patient access is determined on their local CCG’s perception of clinical evidence and cost-benefit.

The gap between centralised decision-making and local decision-making to permit FP10 prescriptions for the FSL optimises the disorganised system currently in effect. With BSA approval on to the NHS Tariff, it would be expected that the NHS constitution is respected and funding provided to all based on ‘clinical need’ (DHSC, 2015), needs which have been defined by the Regional Medicine Optimisation Committees (RMOCs). RMOCs were created in response to the Accelerated Access Review: Interim Report, published in October 2015, which aimed to ‘reduce unnecessary barriers [to accessing medicines]’ when they are not approved by NICE (NHS England, 2016). Theoretically, this should have been the answer to national access to FSL.

Yet this is far from the case. As of 20th August 2018, 126 of the total CCGs have agreed to put FSL on their budget plan, and a further 6 have committed to follow RMOC guidelines once delivery plans are set (Cahm, 2018b). This means currently 62.21% of the estimated type 1 population in England currently has the Libre available on their CCG’s budget (Cahm, 2018a).

The irony in the cautious uptake of the FSL by CCGs is that the 2010 White Paper, one of the driving documents towards NHS reform and the establishment of CCGs, demanded for changes due to ‘poor comparative outcomes in relation to mortality rates’ for acute diabetes complications (Speed and Gabe, 2013, 565). It would therefore be expected that improving complications outcomes should be a top priority for all CCGs.

Yet even within the CCG areas accepting to fund FSL, eligibility criteria set by CCGs varies across England. RMOCs created comprehensive guidelines for FSL access for CCGs to follow. However, the guidelines CCGs are adopting have not been standardised. 106 CCGs are currently adopting RMOC recommendations verbatim, 24 CCGs have edited RMOC criteria, and 2 CCGs have created bespoke criteria (Cahm, 2018b). This is far from RMOC’s purpose to ‘eliminate duplication of medicines evaluation’ by ‘bringing these activities to the regional level’, as described by Dr Keith Ridge (NHS England, 2016). Without legal binding to RMOC decisions (Kar, 2018a), there remains little strength in unifying decision-making and bringing national guidelines to the local level, thus disregarding the very purpose RMOCs were created.

The problem with access to FSL in England due to CCG funding and access restrictions is evident when compared with access in Scotland, Northern Ireland, and Wales. Since national approval for FSL on FP10 forms, Northern Ireland (NI) is now prescribing FSL to 33.25% of the population with Type 1, Wales 12.24%, and Scotland 7.46%, compared to 1.57% in England (fig. 1: Cahm, 2018a).

Fig 1. Cahm, 2018a

The difference being that England puts prescribing power into the hands of local CCGs rather than higher national bodies. In the other nations, such as NI, the Libre was available on prescription to all, with access pathways determined at a national level by the Regional Diabetes Network in December 2017 (Brogan et. al, 2017). This was delivered to all five NHS NI trusts for implementation, to prevent variation in care, with all areas prescribing (Brogan et. al, 2017).

With almost a year passing since FSL was accepted on to the Tariff for FP10 prescription, the comparative figures for England are not acceptable. To combat the slow uptake, Partha Kar suggests enforcing a requirement for all items on the NHS Tariff to reach ‘100% national access within one year’ (2018b), which would improve access within the bounds of the current system. If

NI is able to provide national access with such a high uptake, it should be expected that similar figures are found in England.

Another argument made by CCGs is the cost compared to the base level cost of test strips; yet this is proven to be an unsubstantiated argument in many cases. Preventing access to FSL based on short-term budget does not take into account downstream intervention costs. Total diabetes costs to the NHS, assuming without inflation, is projected to rise to £16.9 billion by 2035/36 (Diabetes UK, 2014, 9). With 80% of diabetes costs currently due to complications (Diabetes UK, 2014, 7), and the likelihood of more price hiking in the future based on the 86.1% price increase over the last decade (NHE, 2016), the NHS must take greater steps in the prevention of complications. FSL may cost more than 4 test strips per day on the current market, but the overall cost of improving glycaemic control using FSL ‘can be less than those that arise from self-monitoring’, when targeting most needed groups as advised by RMOCs (Kar, 2018a).

Furthermore, the potential long-term cost benefits of using FSL to prevent complications are shown in improvements to Glycaemic Variability (GV). The IMPACT study, the largest trial so far of 239 participants with well controlled type 1 diabetes, found that the Freestyle Libre reduced time in hypoglycaemia by 38% and reduced GV (Bolinder et. al., 2016, 2258). Although there was minimal change in HbA1c, current evidence shows increased GV is an important risk factor directly responsible for the pathogenesis of vascular diabetes complications (Hirsch, 2015, 1612). With type 1 complications costing the NHS approximately £800,000 per year based on 2010/11 figures (Diabetes UK, 2014), it is imperative, both for patients’ quality of life and the NHS budget, to take preventative action against complications. From this perspective, FSL can be seen less as an economic hindrance, but an investment in preventative care.

In summary, in the short term, the problem of equal access within the NHS must be addressed. For FSL and other treatments aimed to reduce future complications, reduce downstream intervention costs and improve quality of life, it is imperative that the NHS takes greater steps to unify decisions made on diabetes healthcare.

If a true ‘national’ health service is to be maintained, systematic change is needed. Patient access should be decided at a national level in concurrence with FP10 approval on the NHS Tariff, and should not be in the hands of local CCGs. NHS England must make efforts to improve medical evaluation stages, using the systems in NI, Scotland and Wales as an example. It should not require lengthy multi-tiered systems of authorisation, which both increases time before patient access and duplicates evaluation.

 

References

Bolinder, J., Antuna, R., Geelhoed-Duijvestijn, P., Kröger, J., Weitgasser, R. 2016. Novel glucose- sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet. 388(10057), pp.2254-2263

Brogan, J., Hinds, M., Harper, C. 2017. Letter to Trusts Chief Executives. 4 December.

Cahm, C. 2018a. July Update – CCGs Under Pressure! [Online]. [Accessed 24 August 2018]. Available from: http://www.t1tenor.com/2018/07/july-update-ccgs-under-pressure.html

Cahm, C. 2018b. August Libre Update – Data, data and more data! [Online]. [Accessed 24 August 2018]. Available from: http://www.t1tenor.com/2018/08/august-libre-update-data-data-and-more.html

The Department of Health and Social Care (DHSC). 2015. The NHS Constitution for England. [Online]. [Accessed 24 August 2018]. Available from: https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhs-constitution-for-england#principles-that-guide-the-nhs

Diabetes UK. 2014. The Cost of Diabetes Report. [Online]. London: Diabetes UK. Available from: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes%20uk%20cost%20of%20diabetes%20report.pdf

Hirsch, I. 2015. Glycemic Variability and Diabetes Complications: Does It Matter? Of Course It Does! Diabetes Care. 38. pp1610-1614.

Kar, Partha. 2018a. Letter to CCG Accountable Officers, CCG Clinical Leaders, and Directors of Commissioning Operations. 30 January.

Kar, Partha. 2018b. Interview with R. Barlow-Noone. 20 August, Manchester.

NHS England. 2016. Regional Medicines Optimisation Committees. [Online]. [Accessed 23 August 2018]. Available from: https://www.england.nhs.uk/medicines/regional-medicines-optimisation-committees/

Speed, E. and Gabe, J. 2013. The Health and Social Care Act for England 2012: The extension of ‘new professionalism’. Critical Social Policy. 33(3). pp. 594-574.

The King’s Fund. An alternative guide to the new NHS in England. [Online] [20 August 2018]. Available from: https://www.youtube.com/watch?v=8CSp6HsQVtw

 

*About the Author

Rebecca Barlow-Noone currently studies Medical Sciences at the University of Leeds, and is the co-founder of DiaTravellers, an online travel platform for people with diabetes. She represents the UK as the Young Leader in Diabetes for the International Diabetes Federation, and is on the Diabetes UK Young Adults Panel.