2018 Round-up of Noteworthy Medicines Law and Policy Events

We are reaching the end of 2018: Time for our end-of-the-year roundup of some significant developments in medicines law and policy.


The Chilean parliament started 2018, on 3 January, with the adoption of a resolution calling on the President to advance the compulsory licensing request for medicines needed to treat hepatitis C. The request was made by patients, their advocates and elected officials in March 2017. The adoption of resolution Number 1014 was unanimous. In Chile the cost of sofosbuvir, one of the essential medicines to treat hepatitis C, was US$36,000 per patient per year.

The Drugs for Neglected Diseases Initiative together with Sanofi announced the submission to the European Medicines Agency of the request for the review of their medicine fexinidazole, the first ever oral treatment for sleeping sickness, a disease endemic in Africa.


On 15 February, 18 members of the US House of Representatives called for compulsory licensing of patents for the treatment of hepatitis C. In their letter, they point out that high prices of antiviral medicines such as Gilead’s Harvoni (sofosbuvir/ledipasvir) and Abbvie’s Mavyret (glecaprevir/pibrentasvir) led to restrictions of reimbursement of treatment cost to only patients with advanced stages of the disease, such as liver damage. Starting treatment earlier can prevent such serious and life threatening complications. In the US, Harvoni is priced at US$ 96,000 for a 12 week course, some have negotiated a price of US$ 20,000. Mavyret is priced in the US at US$ 26,400.

Also in February, the Swiss NGO Public Eye obtained a copy of a letter by Novartis CEO Joseph Jiminez written to the President of Colombia to persuade Colombian authorities to refrain from using compulsory licensing to assure access to lower-priced versions of the cancer drug Glivec (imatinib). Novartis had earlier threatened Colombia with an investor state dispute under the Swiss-Colombian bilateral investment treaty. For details see here. For the time being, the compulsory licensing procedure is on ice. You can monitor compulsory licensing requests using our TRIPS Flexibilities database, available here.


The Bulletin of the World Health Organization published a new paper documenting the use of TRIPS flexibilities in the procurement of medicines from 2001-2016. The paper shows that the use of TRIPS Flexibilities was more frequent than is commonly assumed. The data that formed the basis for the paper is maintained by Medicines Law & Policy. Check out the month of December in this post for more information!

In March, Malaysia’s hepatitis C treatment implementation took off following the decision to issue a compulsory licence of sofosbuvir patents in September 2017, which made it possible to procure and supply generic antiviral medicines. Malaysian media reported that patients will receive treatment for free that the government buys for the price of RM1,000 (About US$ 240,-) per patient.


The Indian/Brazilian/South African research project Accessibsa published a report titled “Pharmaceutical Patent Grants in India: How our safeguards against evergreening have failed, and why the system must be reformed”. The paper offers a comprehensive analysis of pharmaceutical patent applications filed in India between 2005 (the year India introduced medicines product patents) and 2016, that could be classified as “secondary”. The authors come to the conclusion that secondary patents account for 72% of all pharmaceutical patents granted in India and that all of those were granted in contravention to the Indian Patents Act. The report offers recommendations for the Indian Patent Office to improve the examination of medicines patents and for amendments to the Indian Patent Law.


At a side event of the World Health Assembly, the Swiss organisation Public Eye launched its campaign “Protect Patients not Patents” drawing attention to the fact that high medicines pricing is now a global issue affecting even high-income countries like Switzerland.

The Dutch research group Technopolis published its report on “Effects of Supplementary Protection Mechanisms for Pharmaceutical Products” commissioned by the Dutch government. The report analyses the innovation and economic impact of European Union mechanisms to create or expand market exclusivities for pharmaceuticals such as the Supplementary Protection Certificate, market and data exclusivity, paediatric extension and orphan drug designation. The report makes recommendations to assure effectiveness for innovation and reduce unintended use of the mechanisms by the industry. Read more about the effects of exclusivity rights on our blog.

And the Norwegian parliament debated whether to use compulsory licensing to respond to the extremely high price of Biogen’s Spinraza, a treatment for spinal muscular atrophy that costs NOK 7 million (US$ 847,000) per patient for the first year of treatment. The proposal was rejected by the parliament. The health minister argued that there was no public health emergency justifying the move (which is, in fact, not a requirement for a compulsory licence. See our comment on that common misunderstanding). The minister also argued that no production of lower-priced product existed  (a situation a CL could actually remedy) and that data exclusivity required new clinical trials (an issue governments indeed can and need to resolve).


Former Goldman Sachs chief economist Jim O’Neill expressed his frustration about the pharmaceutical industry’s lack of appetite to develop new antibiotic treatments. O’Neill, who developed the ‘play or pay’ model to lure the industry back into this field of research, told the Financial Times: “I am shocked at the endless words that come from the pharma industry about their collective belief in the need to fight AMR [anti-microbial resistance], but the lack of concrete initiatives and more importantly, money, they are prepared to underwrite.” He explained that if the carrot does not work, the stick might and that therefor continued industry inactivity should be met with a levy on the sales of other drugs.

In a letter to the Dutch Parliament, the minister of health outlined measures he can take at national level including: changes to the law on medicines pricing, financial and reimbursement arrangements, price transparency and compulsory licensing. The minister of health together with the minister of economic affairs will establish a national commission to examine the use of compulsory licensing by the government to deal with expensive patented medicines. Compulsory licensing was recommended by the Council for Health and Society in their report ‘Smarter development, stronger negotiation’ in 2017.


On 25th July, the Court of Justice of the European Union (CJEU) gave its preliminary ruling on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products in the Truvada (TD/FTC) case. The ruling opened the door to generic versions of the product in countries such as the UK, where an SPC is in place. Truvada (TD/FTC) is used for the treatment and prevention of HIV. In the Netherlands, where the SPC was never granted, the lowest price for 30 tablets/capsules of generic TD/FTC is Euro 29,91. In the UK where Gilead maintained its monopoly position because of the SPC, the full price for 30 tablets was £355,73 (Euro 395,–). Here is our write-up of the case.

The 22nd International AIDS Conference took place in Amsterdam and Medicines Law & Policy was invited to speak at a session organised by UNAIDS on TRIPS Flexibilities. See here for a summary of our input published by the South African news site Spotlight titled ‘AIDS2018: Is cancer the new AIDS?’. The 2018 AIDS Conference was also the place where women activists and their supporters drew a line in the sand condemning the UNAIDS leadership for its lack of action to counter sexual harassment and abuse of power in the organisation.


The newly established Dutch Pharmaceutical Accountability Foundation announced its first action to address unreasonably high medicines prices. The Foundation prepared a request to the Netherlands Authority for Consumers and Markets to look into the price hike for the medicine chenodeoxycholic acid (CDCA) for the treatment of CTX, a rare metabolic disease, and to take action against the company Leadiant Biosciences Ltd. The company was responsible for a 500-fold price hike of the product, which increased the annual treatment cost per patient from € 308 to € 153.000. Leadiant established a dominant position in the market after it obtained orphan drug designation for the product from the European Medicines Agency, which gave them 10-year market exclusivity. The case made newspaper headlines in the Netherlands as well as internationally.


Unitaid expanded its work on intellectual property and access to medicines and announced three new projects it will finance in this field. Third World Network, ITPC and South Centre will together receive grants of a total of US$ 22 million for work on the implementation of TRIPS flexibilities. The grants stem from a 2017 Unitaid call for proposals to help countries use flexibilities in patent law and provisions under global intellectual property agreements to improve access to affordable medicines.


On 17 October, Prof. Mariana Mazzucato’s UCL Institute for Innovation and Public Purpose,  along with STOPAIDS, Global Justice Now and Just Treatment published their report on health innovation titled ‘The People’s Prescription: Re-imagining health innovation to deliver public value’. The report describes where the current innovation system fails to steer efforts into areas of greatest need and sets out principles for a new system such as delinking the cost of research and development from drug pricing. The report provides policy makers with suggestions for short term and longer term interventions. Medicines Law & Policy contributed to the report.


In early November, the drug company Novartis revealed it is considering pricing its new gene therapy for spinal muscular atrophy (SMA) at US$ 4 to 5 million by arguing the treatment could be cost-effective at that price. With this move, Novartis wins the 2018 ‘high medicines pricing’ award.

Also in November, US Senator Bernie Sanders introduced a new bill to bring down the cost of medicines. The bill, if adopted, will empower the US government to strip companies of their intellectual property rights if they price their drugs too high.

At the end of November, the 6th Access to Medicines Index came out. GlaxoSmithKline still leads the pack and Novartis rose from third place to second. The Index noted increasing interest from multinational pharmaceutical companies in doing business in Africa but gaps in registering new products in Africa remain.

Some good news in November came from the DNDi and Sanofi whose new sleeping sickness product, fexinidazole, obtained the green light from the EMA after applying in January (see above for more details).

More good news in November came from the Medicines Patent Pool (MPP), which announced the licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) to help expand lower-priced treatment of hepatitis C.

Over 60 African Civil Society and public interest groups called for greater transparency and inclusion in processes to advance access to medicines by the African Regional Intellectual Property Organisation (ARIPO). The groups ask for reform of the Harare Protocol to ensure uptake of TRIPS flexibilities. They refer to the exclusion of all least developed country (LDC) Members from the requirement to grant or enforce pharmaceutical patents until 2033; the adoption of more stringent standards of patentability that exclude patents on new uses; new formulations and new forms of known medicines and other health technologies; and pre- and post-grant opposition systems. This is the open letter.

The sad news of the passing of Dr Amit Sen Gupta on 28 November shook the global health community. Amit was a leader in the People’s Health Movement and a relentless campaigner for access to medicines. His adage that a “Struggle for health is a struggle for a more caring world” was core to his work. May his ideas and spirit live on. Watch and listen to Dr Amit Sen Gupta here.


Our TRIPS Flexibilities Database went live. The database contains over 150 cases of intended and executed use of TRIPS flexibilities to increase access to medicines. The database will be regularly updated and is publicly available. Dr. Peter  Beyer, Senior Advisor at the World Health Organization, welcomed the database as “a useful tool to demystify the concept of TRIPS flexibilities and to show how these measures have been used in different countries.” The flexibilities in TRIPS received a boost in 2001 when the World Trade Organization’s Ministerial Conference adopted the Doha Declaration on TRIPS and Public Health. Prof Sharon Friel, in a comment in the British Medical Journal called the Doha Declaration one of the ‘Global Health Disrupters’ because it ‘established that a rules based trading system should be compatible with public health interests’.

WHO announced that the Tanzania Food and Drug Authority is the first in Africa to meet WHO standards. The news is an important step for improving drug regulatory capacity on the African continent.

The Medicines Patent Pool announced that the Swiss government and the Wellcome Trust will provide funding to support the organisation’s work to expand into patented essential medicines beyond HIV and HCV. Already in 2016, then GSK CEO Andrew Witty announced that the company was interested in working with the MPP on cancer. Why waste more time. On 19th December, the WHO published its report on Pricing of cancer medicines and its impacts that contains a number of bold recommendations, including a role for the Medicines Patent Pool and the use of TRIPS Flexibilities by governments. In January 2019, the WHO Executive Board will discuss next steps.

Happy New Year!

Ellen 't Hoen
Ellen 't Hoen
Ellen ‘t Hoen, LLM PhD, is a lawyer and public health advocate with over 30 years of experience working on pharmaceutical and intellectual property policies.


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