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 

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

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‘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 

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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 

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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 

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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

Health Breaking News 300

 

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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

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*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.