A pill too hard to swallow: how the NHS is limiting access to high priced drugs
BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4117 (Published 27 July 2016) Cite this as: BMJ 2016;354:i4117
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The fracas between NHS England and the BMJ is an instructive but unnecessary confrontation(1). The ultimate problem clearly lies in the pricing of sofosbuvir and other direct anti-viral agents. Patents ordinarily give exclusive rights of manufacture and sale to the patent holder. There are instances in which the privileges afforded by patents can be lawfully overridden. All 164 member states of the World Trade Organisation (WTO) are signatories to the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)(2,3). Article 31 allows for the abrogation of patent protection under certain circumstances, pertaining particularly to public health. Hence if these circumstances are met, governments can lawfully commission the manufacture of their own generic medication or import cheaper generics(4). Article 31 of TRIPS states that
“Where the law of a Member allows for…use of the subject matter of a patent without the authorization of the right holder,
(b) such use may only be permitted if,…the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public noncommercial use. “
In UK the power to manufacture and distribute a patented product without the patent holder’s authorisation is granted by the UK Patent Office’s comptroller under the provision of the Patents Act 1977ss48-54(5). Hence the £20billion estimated cost of treatment by NHS England(1) should not be a bone of contention but rather should be used to make a compelling and, in many ways, irrefragable case to the patent comptroller in the UK that authorisation could not be granted under “reasonable commercial terms” and hence Article 31 of TRIPS should be evoked. The conclusions of the US Senate Committee on Finance investigation are also admissible; given that it suggested that “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead”(6). The case is even stronger in light of the fact that sofosbuvir is listed among the World Health Organisation catalogue of essential medicines(7). In evoking Article 31 governments, however still are required to pay “adequate remuneration”.
Even if, in the unlikely event, current prices are considered “reasonable”, Article 31 explicitly allows the waiver of patent protection in cases of emergency or “public noncommercial use”. The current situation with hepatitis C treatment in the NHS, with delays literally costing lives; falls firmly into both categories. Article 31 is not a clandestine loophole. Indeed the WTO was so alarmed that this provision was not being evoked more frequently that it expressly reiterated the principles in the 2001 Doha Declaration(8). It explicitly stated that TRIPS should be construed “in a manner supportive of public health, by promoting both access to existing medicines research and development into new medicines”(8,9). It is clear that the WTO anticipated that “market equilibrium” would be achieved. If the cost of pharmaceuticals were excessive, nations would evoke Article 31 of TRIPS and the drug manufacturer would receive little return. Drug companies would thus be encouraged to engage in modest drug pricing. However this equilibrium remains elusive as Article 31 sits as a neglected provision. Clinical eristic may be cathartic but provides no real tangible benefits for patients suffering from hepatitis C. Evocation of lawful exemptions to patent rights provides one possible solution to this polemic.
(1) Gornall J, Hoey A, Ozieranski P. A pill too hard to swallow: how the NHS is limiting access to high priced drugs. BMJ. 2016 Jul 27;354:i4117
(2) https://www.wto.org/english/thewto_e/thewto_e.htm
(3) https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm
(4) https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm
(5) https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
(6) McCarthy M. Hepatitis C drug maker puts profit ahead of patients, US Senate report charges BMJ 2015;351:h6573 (Published 03 December 2015)
(7) http://www.who.int/mediacentre/news/releases/2015/new-essential-medicine...
(8) https://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm
(9) https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm#trips
Competing interests: No competing interests
Dr Howell is correct in suggesting that reorganisations can be wasteful.
We have now an NHS body called SUSTAINABLE DEVELOPMENT UNIT.
Abolish it today and transfer the staff to useful work in hospitals, in GP surgeries, in the so-called community.
Is that a pill too hard to swallow?
Competing interests: I want NHS money spent on patients,
Sometimes NHS reorganisations move things backwards rather than just slowing progress. Gornall, Hoey and Ozieranskis' interpretation of the decisions around the new drugs for treating hepatitis C misses out that NHS England was substantially "under managed" in the first 2-3 years.
One of the losses of the 2013 NHS reorganisation was the agreement between the 152 PCTs in England to share the funding of a small group to comment andfeedback on proposed NICE guidance. After 2013 with the loss of a substantial number of all types of managers many of the checks and balances in commissioning went missing. Initially neither NHS England or randomly selected CCGs were in a position to comment or adequately plan for any forthcoming NICE guidance. This was a loss of planning in both clinical and financial terms. Another example was the NICE guidance on complex cardiac devices (ICDs and CRTs) which were unanticipated and might cost an additional £200 million per year.
It has taken time for NHS England to start to establish a closer relationship with NICE and it has always been difficult when the people offering the guidance to commissioners do not have accountability for the fixed NHS budgets that are needed to fund the best value health care.
Competing interests: Recent employee of Public Health England and working with NHS specialised commissioning. Member of the HST committee at NICE.
There has been a long recognised tension at the heart of the NICE/NHS England relationship between clinical effectiveness and budgetary implications; sofosbuvir has only served to bring this to the fore.
Publicly NHS England states that it “does not refer to the incremental budget impact of treating patients with sofosbuvir”[2] whist simultaneously advocating an approach inclusive of displacement effects of new technologies (i.e. “if £300m were diverted from the existing budget to pay for hepatitis drugs, 1542 lives would be lost across the rest of the NHS”[3]). Ultimately, NICE technology appraisals are premised on a rising healthcare budget which can shoulder the cost of new therapeutics, yet since the health budget is failing to keep pace leaving NHS England unable to afford all the services it seeks to provide.[1] The covert delay tactics are a product of this situation rather than a direct attack on those with hepatitis C.
It is completely understandable that the hepatitis C lobby feels let down by NHS England, yet to dismiss the affordability question out of hand - and attack NHS England's underhand tactics - fails to consider the broader context: why are new drugs so expensive and how can we progress with the numerous proposals which have been put forward to challenge the status quo? What could be done to improve prevention measures and reduce reliance on expensive cures? (90% of new cases of Hepatitis C in 2014 were attributable to intravenous drug use.[4]). How can we contain healthcare costs whilst embracing medical advances and caring for an older, sicker population?
Until such questions are more openly discussed we will have more deflecting tactics from NHS England as well as an unstable relationship between NICE and NHS England, increasingly arbitrated in the courthouse.
[1] Claxton, K. et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol. Assess. 19, 1–504 (2015).
[2] National Institute for Health and Care Excellence. Hepatitis C (chronic) - sofosbuvir [ID654]: committee papers (Document 13: Appendix B ‘Letter inviting consultees and commentators to comment on the proposal to extend the statutory funding period’). (2014).
[3] Gornall, Jonathan, Amanda Hoey, and Piotr Ozieranski. "A pill too hard to swallow: how the NHS is limiting access to high priced drugs." BMJ 354 (2016): i4117.
[4] Public Health England. Shooting up: infections among people who inject drugs in the United Kingdom, 2013. (2014).
Competing interests: No competing interests
Perhaps I am missing something too obvious for words but a solution to the increasing strain that high cost drugs are causing seems barn door obvious to me.
The vastly numerous minor and self limiting illnesses and injuries and their associated low tech and, usually, low cost treatments that absorb so much NHS resource are a prime target for attention. Certainly in primary care it ought to be possible to agree a basket of conditions/symptoms for which assessment and advice are freely available but for which the patients can be expected to pay for the treatments, if any, required. Private prescriptions for some items may be needed.
For example: where the symptoms and signs suggest uncomplicated dyspepsia then self funding would be required for antacids and acid suppressing medication etc. but where objective evidence (endoscopic or imaging) for significant pathology exists then the NHS pays.
How many thousand prescriptions for low tech treatment need to be avoided to permit a single high cost treatment for serious pathology?
Such an approach might well, eventually, lessen the demand upon primary care by diverting a proportion of patients straight to retail pharmacy.
Yours sincerely
Steve Ford
Competing interests: No competing interests
The investigation by Gornall and colleagues shows that stakeholders blame NHS England (NHSE) for the slow and limited access to the new hepatitis C medicines. However, the tactics used by NHSE are a reflection of a fundamental challenge that the medicines appraisal system in England is facing: The new hepatitis C medicines have with one fell swoop challenged the cost effectiveness paradigm, which is perceived as reliable by so many stakeholders in the NHS, and for which the NHS receives much admiration around the world.
The issues that arise are more complex than health system bodies such as NHSE or NICE could hope to resolve by muddling through elegantly (Mechanic, 1997; Lindblom, 1959). The issues have to be resolved at policymaking level. A recent international analysis on public participation in decision-making on the coverage of new hepatitis C drug suggests that policymakers need to be receptive to the issues highlighted by the public, patient and clinician advocacy groups in appraisal processes – they have to be willing to let the issues shape the policy agenda (Kieslich et al., 2016). It is difficult to imagine a case where the need for receptiveness, and responsiveness, by policymakers has been more apparent than in the case of new hepatitis C drugs. Reviewing the financial incentive system for pharmaceutical manufacturers to invest in innovative drug developments is one item on the agenda (Roy and King, 2016). However, more fundamentally, the government must review the mandates and resources of public bodies such as NHSE and NICE to ensure that perceived goal conflicts (Littlejohns et al., 2016), such as the one between affordability and cost effectiveness, can be managed appropriately. Otherwise we will continue to see political tensions between public organisations that ultimately result in unsatisfactory situations for patients, clinicians and taxpayers alike.
References
Mechanic, D. (1997) “Muddling through elegantly: Finding the proper balance in rationing”, Health Affairs, Volume 16, Issue 5, pp. 83-92.
Lindblom, C.E. (1959) “The Science of "Muddling Through"”, Public Administration Review, Volume 19, Issue 2, pp. 79-88.
Kieslich, K., Ahn, J., Badano, G., Chalkidou, K., Cubillos, L., Hauegen, R.C., Henshall, C., Krubiner, C.B., Littlejohns, P., Lu, L., Pearson, S., Rid, A., Whitty, J.A., Wilson, J. (2016) “Public participation in decision making on the coverage of new antivirals for hepatitis C”, Journal of Health Organization and Management, Volume 30, Issue 5.
Roy, V. and King, L. (2016) “Betting on hepatitis C: how financial speculations in drug development influences access to medicines”, BMJ 2016;354:i3718, doi: 10.1136/bmj.i3718
Littlejohns, P., Knight, A., Littlejohns, A., Poole, TL. and Kieslich, K. (2016) “Setting standards and monitoring quality in the NHS 1999–2013: a classic case of goal conflict”, International Journal of Health Planning and Management, doi: 10.1002/hpm.2365.
Competing interests: No competing interests
Compulsory licences for direct-acting antiviral drugs for hepatitis C
Unlike England, Italy does not have a NICE. The decision to ration treatment with the new direct-acting drugs against hepatitis C virus was taken behind closed doors by our Ministry of Health. No need to go through all the troubles well described by Gornall et al in their article.1 In Italy, a 12-week course of treatment with sofosbuvir costs 41,000 euros and the Ministry of Health has so far given permission for 55,000 treatments, about 5% of the estimated need. The explicit reason for this rationing decision is that universal access to treatment may jeopardize the sustainability of our NHS.
Several proposals have been made so far to overcome this problem and increase access to treatment. An economist in the UK thinks that governments should retain the lion’s share of intellectual property rights and limit patents.2 In the US, a “government patent use” law could be applied that would allow patients in federal programmes to be treated with inexpensive generic medicines.3 We think, however, that the adoption by governments of a compulsory license would radically solve the problem and would also deter other companies from playing financial games, as Gilead did with sofosbuvir.4
Compulsory licenses are possible under articles 27 and 31 of the TRIPs (Trade Related Aspects of Intellectual Property rights) in case of national emergencies.5 Several sources, from the US to China to the World Health Organization, affirm that the burden of death and disease associated with HCV is a national and global priority, and the World Health Assembly has recently deliberated a global strategy aimed at the elimination of hepatitis, as a major public health threat, by 2030.6 The Doha Declaration, adopted by the World Trade Organization in 2001, confirmed in paragraphs 5 that “each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”.7 Compulsory licenses have already been adopted by many low and middle income countries, but there are examples of similar rulings also from high income countries, including Italy.8
Based on the above considerations, we drafted a petition that has been posted in a popular Italian website on international health,9 and that has so far been undersigned by a large number of individuals and organisations.10 Among them, some members of the Italian parliament, representatives of medical colleges and associations, many grassroots associations, and several academics and researchers. The search for signatures will continue, the plan being that by the end of September 2016 the petition will be delivered to the Italian Ministry of Health.
We know that our petition is, politically speaking, a hot potato, very unlikely to be handled and accepted by the Italian government, especially if this is left alone by other countries in the European Union (EU). The chances of success would be higher if similar petitions were submitted to the attention of other EU governments by their respective citizens. Representatives of the health professions should lead such a movement, if they firmly believe that access to medicines is a right that should not be denied in favour of free market.
1. Gornall J, Hoey A, Ozieranski P. A pill too hard to swallow: how the NHS is limiting access to high priced drugs. BMJ 2016;354:i4117
2. Mazzucato M. High cost of new drugs. BMJ 2016;354:i4136
3. Kapczynski A, Kesselheim AS. “Government patent use”: a legal approach to reducing drug spending. Health Affairs 2016;35(5):791-7
4. Roy V, King L. Betting on hepatitis C: how financial speculation in drug development influences access to medicines. BMJ 2016;354:i3718
5. World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights. Marrakesh, Morocco, 15 April 1994 https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
6. Hepatitis C: global ambition, national realities. The Lancet 2016;387:1970
7. World Trade Organization. Declaration on the TRIPS agreement and public health. Doha, Qatar, 14 November 2001 https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
8. Reichman JH. Compulsory licensing of patented pharmaceutical inventions: evaluating the options. J Law Med Ethics 2009;37:247-63
9. Epatite C. Il diritto alla cura. 20 July 2016 http://www.saluteinternazionale.info/2016/07/epatite-c-il-diritto-alla-c...
10. Big Pharma. Una storia che si ripete. 25 July 2016 http://www.saluteinternazionale.info/2016/07/big-pharma-una-storia-che-s...
Competing interests: No competing interests