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 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 

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.

 

 

 

 

 

 

 

 

 

 

 

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 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 300

 

So three years in, what do we know about the impact of the SDGs? 

African Health Ministers Approve Roadmap For Medicines Access, Framework To End Cholera 

Countries of WHO’s EMRO sign UHC2030 Global Compact to progress towards universal health coverage 

The New UK Partnership with Africa: from Rhetoric to Reality 

Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents  

New Health Ministry Of Chile Reaffirms Path To Compulsory Licence For Hepatitis C Drugs 

WTO Trade Policy Review: China, Japan, Switzerland, and the United States question Colombia about compulsory licensing 

Students, Activists, Swarm To Demand UCLA Drop Indian High Court Patent Claim  

The Starting Line: Behind a Push by Foundations to Expand Access to Childcare in Their Cities 

UNPO Newsletter July & August 2018 edition 

Patients’ Bill Of Rights; Game Changer Or Another Policy Paper? 

In India, can universal health care become a reality? 

How The US Elevates Corporate Interests Over Global Public Health. And How The World Can Respond 

FDA adds new diseases to list of those eligible for flawed government 

What to expect from the UN Heads of State meeting on NCDs in September? 

Putting an end to the chronic disease epidemic in Europe and beyond – what are we waiting for? 

Children are our future: we must not fail them in the fight against NCDs 

Ebola situation reports: latest numbers from DRC  

Tuberculosis: the curable disease on the rise, and how to tackle it 

Oral polio drops linked to paralysis in India 

Zambia trial cuts severe malaria deaths by 96 per cent 

Superbug strains resistant to all known antibiotics discovered by Melbourne researchers 

From good intentions to Equitable Solutions in Health Research Collaborations – The Research Fairness Initiative (RFI)  

Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? 

What do land rights mean for women? Five insights from Brazil 

« Le plus grand défi de l’histoire de l’humanité » : l’appel de 200 personnalités pour sauver la planète 

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Application for: The Struggle for Health – IPHU Savar 2018 – 6-13 November 2018 

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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.

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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

 

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 299

 

United Nations Solutions Summit September 2018: call for submissions 

World Humanitarian Day 2018: Remembering Why They Gave Their Lives 

UNHCR: come riusciamo a portare gli aiuti ai rifugiati durante le crisi umanitarie? 

Children in humanitarian crises: How the EU can help them 

Five things I’ve learned being a humanitarian aid worker 

In New York City, Addressing The Mental Health Of Migrant Children Separated From Their Parents 

WEMOS: FINANCING FOR HEALTH (SDG3). SHARED GLOBAL RESPONSIBILITY: AN ANALYSIS OF FIVE AFRICAN COUNTRIES 

WHY INVESTING IN HEALTH IS A CHALLENGE UNDER THE CURRENT GLOBAL ECONOMIC SYSTEM 

What Accountability Really Means 

68th session of the WHO Regional Committee for Europe Rome, Italy, 17–20 September 2018

Alma Ata at 40: Midlife crisis or Graceful Maturity? 

Regional cholera outbreak threat in west Africa as cases increase eight-fold in Lake Chad basin 

We must celebrate the end of polio – but the end of polio funding puts other programmes at risk 

The Latest Ebola Outbreaks: What Has Changed in the International and U.S. Response Since 2014? 

Ebola situation reports: Democratic Republic of the Congo 

Measles cases hit record high in the European Region  

Sudden spike in number of measles cases in Europe, highest death toll in Serbia 

Samoa rolls out triple drug therapy to accelerate elimination of lymphatic filariasis 

Negotiators On UN TB Resolution May Have A Deal 

The Long-Term Financial Toll of Breast Cancer 

‘Accessibility to Medicines in Uganda’ by Denis Bukenya and Michael Ssemakula 

Civil Society And TRIPS Flexibilities Series – Translations Now Available 

Can A Surge In Activism Defeat American Big Pharma? 

Il conflitto d’interessi dei medici con Big Pharma 

White House opens new front in war on US aid budget 

Why strengthening land rights strengthens development 

OFID signs loan agreements to help strengthen food security in Cote d’Ivoire, Malawi 

Cruise ships still using ‘dirtiest of all fuels’ must be banned in European ports, says environmental group 

New way to save endangered sharks – and our seafood 

Rights for people forced out by climate change 

This paper examines the vast gap in access to essential drugs in Uganda and highlights the many circumstances of the drug stock-outs culminating into the high premiums on medicines hence frustrating access to medicines and many a time sprouting drug resistance illnesses

By Denis Bukenya

and Michael Ssemakula

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

Accessibility to Medicines in Uganda

The Polygonal Lateral Disease Resistance

 

The five fundamental questions of What, How, Who, Where and When to improve medicine accessibility, is still a heavy quarry assemblage of unreciprocated answers to improve medicine availability and accessibility in Uganda. Due to the shifts introduced by the new health system management embraced by the government of Uganda, there has been the introduction of a neoliberal Public Private Partnerships in the drug procurement and management process. This process has caused untold pain due to drug-stock outs. The scourge of stock-outs inherits terrible dynamics of worsened plights of disease from critical to chronic levels especially among the susceptible HIV/AIDs and Non Communicable Disease (NCDs) patients.

Over the years, the vacuity in access to medicines especially those for NCDs has been worsened by the commercialization of the health sector which has become an integral center of worry to the citizenry and turning health into a private good as opposed to a social good provided by the state as a prerogative service. In a report on access to medicines by Hazel Bradley and Richard Laing (2015), 33% of the expenditures on NCDs drugs are out-of-pocket expenditures, implying that those who cannot afford will either opt for cheaper medication which is counterfeit and ineffective causing disease resistance, continue to struggle with the illnesses and hope for a spiritual miracle or befall the preventive death sentences due to the medicine stock-outs and the state ineptness in the protection of the right to health.

This paper examines the vast gap in access to essential drugs in Uganda and highlights the many circumstances of the drug stock-outs culminating into the high premiums on medicines hence frustrating access to medicines and many a time sprouting drug resistance illnesses.

The heavyweight burden of disease in Uganda has continued its vicious existence due to the vacuum in access to medicines especially the essential drugs. The deficiencies of essential medicines in public health facilities is a major issue. Despite the increasing attention to this predicament (plentiful reform attempts and creativities in the last ten-years have been used in assessment and evaluation of health facilities, State medicine provision and health human resources), the general population still experiences scarcities of medicines. When patients are unable to get the affordable care needed from the public sector (government hospitals, clinics and government drug authorities in charge), they turn to the atrocious private sector which includes the pharmacies, clinics and nonconformist state of the art private hospitals for profit owned by the politicians in the third world countries which charge them exorbitant prices in accessing medical care. This in effect increases the out of pocket expenditure on access to health putting the citizens at risk of deteriorating into poverty as an after effect to ill-health. This has aligned many defects in the health systems in Africa including counterfeited drugs, the sale of expired drugs and turning to herbal unregulated medications which may harm the general populations.

Considering the inner-city populations in the foregoing, one would literary argue that paying surcharge premiums for essential medicines that should be available at no cost from the public health sector creates  poverty in the economy, robs the citizenry of their fundamental right to attainable standards of health and breaks the SDGs slogan of leave no one behind.  The rural poor populations due to the scarcity of functional public and private health facilities, suffer the consequences of long distance treks to access health care which many a time conclude in avoidable deaths and reduce the percentages of lives for the people living in the rural poor areas.

Looking at essential drugs like trastuzumab whose 440mg of the original drug’s brand version costs Shs 9m whereas its generic costs Shs 4.1m as evidenced by the Uganda Cancer Institute, makes the case that the influence of unaffordable premiums charged on the patented cosmopolitan medicines puts health in a dire state especially for Non-Communicable Diseases (NCDs).

This in Uganda is worsened by the scourge of counterfeit products, medicines in this regard. These are plentiful on the market hence the reason why people in the country are dying from manageable ailments where presumably the medication is readily available in circulation. The management of these counterfeits in Uganda is said to be failing at an unimaginably high rate due to the crippling corruption in the country which makes the cost of curbing, enforcement and regulation of counterfeit medication impossibly high.

There is also a gap on the stock-outs in Uganda due to the institutional inefficiency in the Ministry of health and a link-gap in the information flow between the procurement pharmacy departments and National Medical Stores (NMS) in documenting the status on the drug stocks. Crossing over to the HIV/AIDS drugs, malaria and other preventable and treatable diseases including the Sexual Reproductive Health Commodities, people survive by a two-faced chance. Since May 2018 reports show how the medicine stores in Uganda started going empty.

Further, the recent research survey carried out on 6^th and 7^th August 2018 by the Uganda Coalition on Access to Essential Medicines (UCAEM) a Civil Society Coalition in which Human Rights Research Documentation Center (HURIC) and PHM-UGANDA bear membership, revealed gory stories of gaps in the availability of essential medicines, family planning and Sexual reproductive health commodities across the eight-health centers in Lira and Pallisa districts. This survey reflected the absence of the following drugs, septrin (Cotrimoxazole), emergency contraceptive pills, Combined Oral Contraceptive pills (like microgynon), Progestin, HCG kits, Combined injectable Contraceptives, Sino Implants, Implanon Classic, ibrogfen tabs, Depo-provera, IUCD, Moon beads, Norigynon, Microrute, Jade  NXT, IUD and a national-wide stock-out crisis in Anti-TB drugs, ARVs, Vaccines and malaria diagnosis equipment. The drug prices and medicine stock-outs have significantly widened the medicine availability and acquirability in Uganda. Upon realizing that there are no drugs in public health centres, patients have resorted to private health facilities and pharmacies which sell the medicines at a cost way above the affordability line of the patients, with some drugs being counterfeits especially the cancer drugs and cardiovascular disease drugs.

In the recent past, reports from World Health Organization warned Uganda’s authorities (the Uganda National Medical Stores) on the procurement of fake copies of the Roche’s Avastin and Pfizer’s Sutent used to treat cancer (WHO, 2017). These had hit the medicine market through pharmacies and scamming patients through the fake generic drugs thus becoming one of the interlopes to end disease in Uganda as a result of the institutions’ inefficiencies and a gap in the ethical values.

The incompetent drug tracking system and inconsistences in the procurement plans in the pharmacy department and the National Medical Stores as the national entrusted bodies mandated to procure medicines and store them, is another key prime cause of medicine inaccessibility in Uganda that increase fluctuations. The gist here is that the dilemma of medicine inaccessibility in Uganda is not only about the tight resource constraints and technical gaps, but also a sequence of poor political rationalities that permit and reinforce temporary makeshift policy-implementation that results in weak oversight and a gap in meaningful accountability. The ramifications for this inadequacies are translated into preventable deaths due drug resistance and reduced DALY years of the general population.

With such paucities in our health system, commercialization drive has been inevitable through importation of expensive medicines by private pharmaceutical companies. Which makes the poor strata to suffer severely.

It is therefore recommended that appropriate drug tracking systems are put in place together with training of properly qualified health professionals in the health procurement departments to improve their stock taking capacities and narrow the gap in the information flow between the health workers at grass roots like the store managers, procurement and finance departments. Such skills training is needed for the health professionals in health centers’ inventory management systems to learn the new technologies involved in drug implementation tracking processes as a tool to better the practice of reconciling the medicines stock-gaps to minimize shortages, human errors and streamline ardently the inventory management procedures.

Also a need for right supportive political rationalities is necessary. This will permit and strengthen policy-implementation on strategic plans for medicine provision with strong oversight and meaningful accountability.

Finally the need to negotiate for parallel importation from the medicine patent holders and originators of the medicines is essential. This is because parallel importation allows the country to procure medicines from a cheaper source where the originator or patent holder sells his drugs at a lower premium than the actual price cost from the patent holder of the medicines. This reduces the cost incurred in purchasing the medicines thereby increasing their affordability and accessibility to all patients regardless of social status.

 

 

 

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: Link 298

 

5 experimental treatments introduced in latest DRC Ebola outbreak 

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‘This is a very dangerous outbreak’: WHO chief ‘worried’ over Ebola in DRC, as experimental treatment begins 

WHO calls for free and secure access in responding to Ebola outbreak in the Democratic Republic of the Congo 

Opinion | Ebola responders must learn language lessons from the 2014 epidemic 

Inside Namibia’s HIV success story 

African governments are far from powerless in global health initiatives like those against AIDS 

Malawi study boosts calls to roll out rotavirus vaccine in more countries 

A post-conflict vaccination campaign, Central African Republic 

Mutant mosquitoes: Can gene editing kill off malaria? 

MSF applauds the World Health Organization’s move to recommend improved tuberculosis treatment options  

What would a feminist approach to localisation of humanitarian action look like? 

Akeredolu reverses self, adopts Mimiko’s free health services for pregnant women, children 

Integrating Care for Children, Young People and Their Families 

Alternative malnutrition treatments hold promise for millions of children 

Strategic orientations for the future of child health in a new online collection at BMJ 

Human Rights Reader 457 

Civil society calls on G20 leaders to urgently take joint action in tackling global challenges 

Take Charge of Your Food: Your Health is Your Business 

African countries fare poorly in innovation ranking 

‘Promoting Some Literacy on the Health Systems of Countries of Origin of Migrants in Europe’ by Yves Charpak 

‘Public Finance and Public Health’ by Ted Schrecker 

Gilead loses key patent claims for Sovaldi in China, opening door to earlier generic entry 

KEI and UACT comments on the prospective grant of an exclusive license to Midissia Therapeutics 

Health as if Everybody Counted (second edition) by Ted Schrecker, Professor of Global Health Policy 

Watermelon rind a cheap filter for arsenic in groundwater 

Truth Squad: Bloomberg’s Latest Move to Fight Big Tobacco in the Global South 

It Takes an Oncologist: A New and Promising Tobacco Control Initiative

How coal-burning countries are making their neighbours sick 

Working with China on Pacific climate change 

IPHU Course announcement: The Struggle for Health – Savar 6 to 13 November 2018, Bangladesh 

Finance ministries are the most important ministries for improving population health – first, because they determine the budgets available to health ministries; second, because their policies determine the capacity of governments to meet health-related economic and social policy objectives (through taxation) and the distribution of the benefits of those policies (through their expenditure priorities)

By Ted Schrecker

Professor of Global Health Policy, Newcastle University

Public Finance and Public Health

 

I have argued for many years that public finance is a public health issue.  Against the odds, this view appears to be gaining credence.  The Disease Control Priorities Project is a massive effort to identify the most ‘cost-effective’ options for improving health, funded by the Bill and Melinda Gates Foundation and organised by the World Bank.  The authors of a summary of its nine volumes of recommendations argued that ‘[i]n all likelihood, the finance ministry is the most important ministry (after health) for improving population health’.  Their argument related mainly to the options for taxing such health-destructive commodities as sugary drinks, while reducing subsidies on fossil fuels.  These are all laudable and important objectives, but we must go further.  Finance ministries are the most important ministries for improving population health – first, because they determine the budgets available to health ministries; second, because their policies determine the capacity of governments to meet health-related economic and social policy objectives (through taxation) and the distribution of the benefits of those policies (through their expenditure priorities).

In the United Kingdom, since 2010 we have witnessed an especially striking illustration of this point.  Tax and benefit policy changes have substantially reduced the incomes of those households near the bottom of the economic distribution, with minimal impact on those near the top.  Food bank use has increased sharply, and this is almost certainly only the tip of the health impact iceberg; the most deprived local authorities, which derive much of their income from central government, have been hit hardest by budget cuts and are closing libraries and preventive services like smoking cessation, even as the National Health Service simultaneously cuts back on stop-smoking prescriptions.  Indeed, the NHS as a whole is in a state of continued crisis because of government’s unwillingness to provide adequate funding from general tax revenues.  Meanwhile, corporate tax policy allows firms like Amazon to pay minimal taxes in the UK, even as their low operating costs – thanks to a perverse structure of business rates (taxes) – contributes to the destruction of high street retail.  This is likely to have at least indirect health consequences, for example as town centre dwellers whose age, abilities or finances mean they cannot hop in the car and drive to a suburban shopping park lose ‘control over destiny’.

Against this background, central government continues to commit tens of billions of pounds to megaprojects like high speed intercity rail lines and foreign-built atomic power stations.  If the World Health Organization’s important message of health in all policies had been taken seriously, at the very least we would have independent, peer-reviewed health impact assessments of these expenditures, including alternative uses of the funds committed and of the ‘do nothing’ option.  Based on decades of experience with environmental impact assessments, these are essential.  Such assessments are nowhere to be found; health economists’ ritual incantation that resources are limited so priorities must be set clearly does not apply here.

Unfortunately all this will be familiar even to casual observers of UK politics, and has parallels elsewhere, although the public health community has too often remained silent about them.  At the same time, once-radical perspectives on the revenue side of the fiscal policy equation are moving into the mainstream of policy analysis, if not yet of politics.  In 2013, the former head of Canada’s national public service and his son published a powerful edited volume called Tax is Not a Four-letter Word, and decried Canada’s ‘dangerously distorted tax conversation’ – sadly, to little effect.  In February 2018, The Economist warned that ‘[I]f Britons want good public services’ as an alternative to the current collapse, then ‘they will need to pay more’ and hinted at the need for some form of wealth taxation.  In August, it was more explicit.  A leader noted that ‘Amazon’s British subsidiary paid £1.7m ($2.2m) in tax last year, on profits of £72 m’ – an effective tax rate of less than three percent.  The leader also foregrounded the need to tax windfall gains from rising property values ‘in big, global cities’ – which without an effective inheritance tax regime will magnify economic inequalities across generations –  and to reform corporate tax regimes to address the ability of firms like Amazon to shift their revenues to low-tax jurisdictions.  Further, it noted that ‘[a]s the labour market continues to polarize between high earners and everyone else’, with labour’s share of national income in much of the world in a decades-long decline, ‘income taxes should be low or negative for the lowest earners’.  A briefing in the same issue explores one intriguing option – a land value tax, which would capture windfall gains in prosperous areas – in considerable detail.  (Today, taxes on residential property in England and Scotland are assessed on real or hypothetical value in 1991, with a capped ‘top band’ that corresponds to just a small fraction of today’s seven- and eight-figure prices.)

Unfortunately, The Economist did not extend its analysis to such policy options as comprehensive wealth taxation or higher marginal tax rates and alternative minimum taxes on high-income individuals.  Nevertheless, its critical attention to public finance offers the possibility that ‘distorted tax conversations’ may become less so – offering prospects for reducing health inequalities by way of their essential economic substrate.  In these grim and disturbing times, we must seek faint hope where we can.

This posting also appears on Prof. Schrecker’s blog ‘Health as if Everybody Counted’