[Ip-health] Ploumen and Schippers in The Lancet: Better life through medicine—let’s leave no one behind

Thiru Balasubramaniam thiru at keionline.org
Mon Nov 7 18:29:37 PST 2016


LP is Minister for Foreign Trade and Development Cooperation and ES is
Minister of Health, Welfare and Sport for the Government of the
Netherlands. We declare no other competing interests.

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http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext

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Better life through medicine—let’s leave no one behind

Lilianne Ploumen, Edith Schippers
Published: 07 November 2016
DOI: http://dx.doi.org/10.1016/S0140-6736(16)31905-5

The Lancet Commission on Essential Medicines Policies1 rightfully addresses
the need to guarantee access to essential medicines for all. However, we
cannot achieve any real progress without acknowledging that the current
patent-based business model and the way we apply international patent rules
need to change. The system is broken.

Let’s look at the business model first. Sofosbuvir-based medicines are an
important breakthrough in the treatment of patients with chronic hepatitis
C. The problem is that one-time treatment costs between €48 000 and €96 000
in high-income countries (2015 prices).2 There are an estimated 20 000
patients with this disease in the Netherlands,2 and there are millions of
people with hepatitis C virus infection throughout the world. When we take
a look at the development and clinical trial costs of these products, the
current prices appear even more outrageous. Manufacturer Gilead Sciences
Inc invested an estimated US$12 billion in the rights and development costs
of sofosbuvir.3 Gilead Sciences Inc has already accumulated over $35
billion in global revenue from sofosbuvir-based hepatitis C medicines since
their launch in December, 2013, and it anticipates about $20 billion
annually in the years to come.3 This revenue will largely be based on the
protection and exclusivity of its patents.3

Patent and intellectual property exclusivities are the only cornerstone of
the current model. Companies can ask the price they like. This will no
longer do. We need to develop alternative business models. And if public
money is used for the development of new medicines, agreement upfront is
needed about what this public investment will mean for the final price. We
believe that companies must provide full transparency regarding the costs
of research and development (R&D).

<SNIP>

In developing countries the patent-based model fails in making much needed
essential medicines available. Companies do not invest in medicines for
so-called neglected diseases, for which there is no reliable market.
Product development partnerships have already shown their value in tackling
this problem. The Drugs for Neglected Diseases (DNDi), for example,
delivered six new treatments and established a solid drug development
pipeline with a limited €182·5 million budget.4 Their success stems from
putting the needs of patients at the centre of the innovation process.
Through upfront public and philanthropic contributions, R&D costs are
delinked from final consumer prices, to the benefit of affordable and
equitable access to patients. The public sector has shown its willingness
to put money on the table. The time has come for the pharmaceutical
industry to also come forward with more substantial financial contributions.

The way global patent rules are applied is another cause for concern. These
rules provide for safeguards to make sure that all people have access to
the medicines they need. However, in practice, governments are often
submitted to pressure not to use these safeguards.5, 6 This situation
contradicts the Agreement on Trade Related Aspects of Intellectual Property
Rights (TRIPS) of the World Trade Organization (WTO) and its explicit
provisions for a flexible implementation of patent rules in the interest of
public health. For example, in April, 2016, the Colombian Government
followed up on recommendations by a technical expert committee to declare
imatinib (marketed by Novartis) of public interest for the treatment of
chronic myeloid leukaemia to enable the issuing of a compulsory licence.7
Subsequently, this decision was criticised by states and corporations
clearly attempting to dissuade the Colombian Government from issuing a
compulsory licence.8, 9, 10, 11 The drug has generated over $47 billion in
global sales for Novartis.12, 13 The Novartis price for the drug in
Colombia per patient is about $15 000,14 almost twice the Colombian gross
national income per person.15 After negotiations on a reduced price failed,
the government, on June 14, 2016, issued resolution 2475 declaring the
existence of public interest to imatinib7 In September, 2016, the Colombian
Ministry of Health announced its plans to proceed with the price
reduction.15

This example illustrates that steps need to be taken to bolster the
safeguards the TRIPS agreement provides. The Netherlands is campaigning for
these safeguards to be maintained in negotiations on free trade agreements
with developing countries.16 We will intensify our efforts to prevent
so-called TRIPS+ provisions in free trade agreements that are being
negotiated by the European Union and other high-income countries. Such
provisions allow for even longer or more restrictive patent protection—that
is certainly not what the world needs now. In this respect we agree with
the recommendations of the UN High-Level Panel on Access to Medicines5 that
governments and the private sector must abstain from retaliatory threats
that undermine the right of WTO members to use TRIPS safeguards. We will
therefore facilitate an expert meeting to explore concrete actions by which
WTO members can protect the legitimate rights of individual members to
adopt and implement safeguards in the TRIPS agreement.

The system is broken but change is underway to fix it. Governments cannot
do this alone. We need meaningful efforts by both the pharmaceutical
industry and governments to invest in new medicines, provide full
transparency on costs, prices, and who pays what beforehand, and respect
the legal space for governments to protect public health. If we don’t
succeed in these efforts, we cannot guarantee people’s access to innovative
and affordable medicines. Without fixing this broken system we will not
reach the Sustainable Development Goal to ensure healthy lives and
wellbeing for all, at all ages. “Leave no one behind”, the UN’s slogan,
will prove to be empty words.

LP is Minister for Foreign Trade and Development Cooperation and ES is
Minister of Health, Welfare and Sport for the Government of the
Netherlands. We declare no other competing interests.


References

Wirtz, VJ, Hogerzeil, HV, Gray, AL et al. Essential medicines for universal
health coverage. Lancet. 2016; (published online Nov 7.)
http://dx.doi.org/10.1016/S0140-6736(16)31599-9.

Ministry of Health, Welfare and Sport, and Government of the Netherlands.
Summary of medicines plan (p 7).
https://www.government.nl/documents/reports/2016/02/26/summary-of-medicines-plan;
2016. ((accessed Oct 17, 2016).)


Roy, V and King, L. Betting on hepatitis C: how financial speculation in
drug development influences access to medicines. BMJ. 2016; 354: i3718

DNDi. An innovative approach to R&D for neglected patients: ten years of
experience and lessons learned by DNDi.
http://www.dndi.org/wp-content/uploads/2009/03/DNDi_Modelpaper_2013.pdf;
January, 2014. ((accessed Oct 17, 2016).)


UN Secretary-General and Co-Chairs of the High-Level Panel. The United
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http://www.unsgaccessmeds.org/final-report/; 2016. ((accessed Oct 13,
2016).)

The Associated Press. Colombia is threatening Novartis over this cancer
drug’s high price. Fortune. May 18, 2016;
http://fortune.com/2016/05/18/colombia-novartis-cancer-drug-price/.
((accessed Oct 17, 2016).)

Permanent Mission of Colombia to the United Nations. No 1160-E. New York
July 21, 2016. Process for the declaration of public interest of imatinib
in Colombia.
http://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d2e998cd0f68c542159efc/1473440152256/Letter+from+Colombia.pdf.
((accessed Oct 18, 2016).)


Andrés, F. Embajada en Washington. No I-EUSWHT-16-867. Washington, April
27, 2016. Glivec—Novartis.
http://keionline.org/sites/default/files/Florez-27April2016.pdf. ((accessed
Oct 17, 2016).)


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((accessed Oct 17, 2016).)

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the Federal Council for Trade Agreements. CH-3003 Bern, BWAM/SECO/lea.
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((accessed Oct 17, 2016).)


Knowledge Ecology International. Novartis complaints over public interest
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Knowledge Ecology International. Colombia issues public interest
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Novartis sales of Gleevec/Glivec (INN: Imatinib), 2002 to 2016.
https://docs.google.com/spreadsheets/d/1jK7UUCGLSEsmgVMZuW0JrL4IHuNHpyvgjIK1S8vMJ00/pubhtml.
((accessed Oct 17, 2016).)


Vyas, K. Colombia threatens to override Novartis’s patent on Gleevec. The
Wall Street Journal. May 20, 2016;
http://www.wsj.com/articles/colombia-threatens-to-override-novartiss-patent-on-gleevec-1463770091.
((accessed Oct 13, 2016).)



Silverman, E. Colombia plans to proceed with price cut on Novartis cancer
drug. STAT. Sept 16, 2016;
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((accessed Oct 17, 2016).)



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