Landmark court case on Truvada® demonstrates the need to curtail extended IP protection on medicines

The ruling by the European Court of Justice (CJEU) on the validity of Supplementary Protection Certificate (SPC), an obscure intellectual property (IP) mechanism, on Truvada® yesterday [[i]], can save thousands of people from contracting HIV and may mark a shift in the management of the HIV epidemic in Europe. By ruling in favor of curtailing extended patent protection on the medicine, more affordable generic versions may sooner enter the European market. While this ruling is excellent news for patients and health care systems in Europe, the issue of extended protection should now be structurally addressed at a political level in the EU.

The need for Prep

TDF/FTC, first marked by company Gilead as Truvada®, has long been used as an effective antiretroviral medicine for HIV/AIDS treatment, and has been recommended by WHO to be used as pre-exposure prophylactic (PrEP) to protect at-risk individuals of contracting HIV [[ii]]. With 99% effectiveness in protecting people at-risk of contracting the virus, the medicine, when used widespread and correctly, some have argued could be the tidal wave needed to finally end the AIDS epidemic[[iii]] by reducing new any infections to approximately zero.

The high price of the medicine has however prevented countries, including EU member states, from much needed implementing programmes to provide the treatment to at risk populations. A 2016, survey by the European Centre for Disease Prevention and Control (ECDC) revealed that out of thirty-two European countries, thirty-one identified the cost of the drugs as an issue preventing or limiting PrEP implementation and twenty-four among of these rated the issue of high importance [[iv]]. With no generic versions on the market at the time, the price of Truvada® was thus considered the main barrier for access to the prophylaxis

ECDC graph
Graph from ECDC Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. 2016, p.6. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/pre-exposure-prophylaxis-hiv-prevention-europe.pdf

 

Extended patent protection hampering access to medication

TDF/FTC is a combination of tenofovir [[v]] and emtricitabine both owned by Gilead [[vi]]. In 2004 Gilead filed a separate patent application on the combination of TDF/FTC and applied for SPC on TDF/FTC widely in European countries. The SPC mechanism in the EU is a form of patent term extension granted upon patented pharmaceutical products and providing prolonged market exclusivity status upon the expiry of the patent term [[vii]]. In different European countries the SPC extended Gilead’s monopoly on TDF/FTC, as under patent protection, up to another year. With no concerns of competition on the market Gilead could continue to charge illegitimate high prices for TDF/FTC.

Gilead’s SPC application has however been rejected in the Netherlands [[viii]] and revoked in court in France [[ix]] and Germany [[x]], whereas a preliminary injunction by Gilead to prevent generic competition was rejected in Ireland [[xi]]. In other countries as Denmark [[xii]] and Switzerland [[xiii]] the SPC has been maintained. In Belgium [[xiv]] a preliminary injunction has been ruled in favour of Gilead as in the United Kingdom (UK), where High Court Justice Arnold in Teva and others vs. Gilead [[xv]] considered the patent on combining two compounds together does not provide sufficient technical advancement in print and referred the case to the Court of Justice of European Union (CJEU) [[xvi]]. As a result, Truvada® provides a rare case to study the effect of SPC on access to medicines and health care systems in Europe.

As of October 2017, several generic versions of TDF/FTC have been approved by European Medicines Agency [[xvii]], but have not yet been marketed in all member states due to the effects of the associated SPC on TDF/FTC. The availability of generic forms of TDF/FTC on the European market is thus patchy as detailed in table 2 below. The below table lists the status of the SPC on TDF/FTC and the prices of Truvada® and the cheapest generic forms in different European countries. As standardized pricing information is not available across Europe, the available and provided price largely differs between countries. The price table does not serve to compare prices between European countries, but demonstrates the price difference between generics and originator versions, and potential savings, within the same country. Next the table details the availability of generics on the market and whether TDF/FTC for a PrEP indication is reimbursed in the country.

 

Overview medicines

Table 2: Indicated prices are for one packaging of 30 pills of TDF/FTC. Where applicable the price was converted from local currency to euro using XE currency converter and round of the nearest whole euro.

Where the SPC was rejected or revoked affordable generics forms of TDF/FTC became available, as is the case in Ireland, France and the Netherlands. Norway and France were the first countries to reimburse PrEP, lately also the Netherlands and Germany have announced reimbursement. Other countries, as Ireland, and the UK have not done so, possibly because they await the final decision of the CJEU. Except Belgium, none of the countries where the SPC was maintained provide reimbursement for PrEP. The lack of reimbursement combined with the high price of a monthly package of Truvada®, as indicated in the table, compelled individual users to resort to internet purchase for generic alternatives [[xlv]]. In England a generic version of the drug as PrEP is only available within the merits of a clinical trial for 10.000 people [[xlvi]]. However, as demand outstretched availability through the trial, NHS started to facilitate the importation and sales of generics in a clinic in London earlier this year [[xlvii]]. Generic TDF/FTC, on another hand, has been available in global market for more than 10 year.

The decision of the CJEU on 23 July 2018 can finally settle the status of the SPC on TDF/FTC and access to generic versions in Europe. With significantly lower prices for generic versions, between 52% and 91% lower for the indicated countries where generics are available, such a decision may have a profound impact on affordability of a PrEP programme, the reimbursement status of  TDF/FTC as a PrEP, or on the ability of users to buy the medicine on own expenses.

High prices of medicines threatening health systems in Europe

Pharmaceutical expenditure has increasingly become a concern in the EU with expenditure on medicines equalling 17.1% of total health expenditure in the EU and 1.41% of GDP in 2014 [[xlviii]], also the European Comission acknowledged that “[P]ublic  and  private  payers  increasingly  grapple  with  how  to  afford  the  rising  number  of  new  and  often  expensive  medicines.[[xlix]]. As expenditure on new molecules outpaced the growth of GDP and the growth of other health care expenditures, [[l]] concerns of out of control health care expenditure threatening the sustainability of entire health systems in Europe have become more vindicated. In an unprecedented move the European Council in June 2016 under the Dutch presidency, expressed

“concern about examples of a market failure […]where patients access to effective and affordable essential medicines is endangered by very high and unsustainable price levels” and concluded “that the incentives in this specific legislation need to be proportionate to the goal of encouraging innovation, improving patients’ access to innovative medicines with therapeutic added value and budgetary impact […]” [[li]].

 

Why do we need SPCs anyway?

The SPC mechanism in the EU is one form of patent term extension granted upon patented pharmaceutical products, providing up to five additional years of market exclusivity (monopoly) upon the expiry of the patent term [[lii]]. Extensions of exclusive rights beyond patent terms, including SPC, goes beyond the international WTO obligations as required by TRIPS agreement, commonly referred to as TRIPS+. A number of TRIPS+ provisions, including patent term extension, have long been proven to be detrimental to access to affordable medicines in developing countries [[liii]]. Recent literature has also showed the challenges of access to medicines derived from TRIPS-plus practices in Europe [[liv]].

The core justifications for introducing the SPC mechanism in 1990’s as an incentive for innovation, and as a necessity to recoup R&D investment and to compensate for time gaps to commercialise the medicines, have proven to be deeply flawed.[[lv]] While actual and reliable data on the cost to develop a new medicine is scarce, reported figures consistently indicate that prices charged by pharmaceutical companies globally significantly exceed the actual cost of R&D.[[lvi]] Recent academic studies illustrate that companies are increasingly allocating revenues from high drug prices to share buybacks and dividends that boost executive and shareholder compensation. This indicates that most companies are earning returns that both accommodate their prior and future R&D investments and also enable them to pay executives and shareholders excessive compensation.[[lvii]] In many cases, annual expenditure on share buybacks and dividend payments exceed companies’ R&D investments.[[lviii]] From 2006 to 2015, Gilead Sciences, the patent holder for Truvada, sofosbuvir and many antiretrovirals for HIV, spent US$27 billion on share buybacks and dividends, and only US$17 billion on R&D.[[lix]] Over the same 10-year period, 18 large pharmaceutical companies collectively spent US$516 billion on buybacks and dividends, and only US$465 billion on R&D. [[lx]] Experiences in other countries have also shown that there is no evidence of increased investment, or visible incentive to innovate for novel pharmaceuticals after the introduction of extension of patent terms.[[lxi]]

A need to thoroughly review the IP incentives in the EU

While the CJEU’s decision can improve access to more affordable TDF/FTC, potentially saving many thousands of people from contracting HIV in Europe, the court’s decision is purely a legal-technical response on the application and interpretation of IP law in Europe. The far-reaching implications of the decision should serve as a wake-up call for politicians in Europe on the extent to which ever-expanding IP protection, serving the financial interest of the very lucrative pharmaceutical industry, has come to offset the balance with patients’ rights and the sustainability of health care systems.

In recent years, the constraints that extensive IP rights pose on the affordability, availability and access to medicines have come under increased scrutiny and discussion in the EU, with a review of the IP incentives currently ongoing [[lxii]]. With evidences of its intersection with public health the EU member states, the European Parliament and Commission should not shy away from questioning the relevance of the different IP incentives and particularly refrain from imposing damaging IP regulations on third countries.[lxiii] In this debate, it is the responsibility of the European Commission to provide proper evidence in this regard.

While companies claim a need for longer IP protection to recoup R&D investments, reliable date has proven otherwise and more so, the challenge of obtaining actual data on the R&D cost of pharmaceutical companies, especially at product level, further emphasizes the need for more transparency on R&D investments of companies. As the Truvada case demonstrates, SPC merely prolongs market dominant status of pharmaceutical companies leading to high prices for longer periods of time. At a time that rising prices of medicines threaten the sustainability of social security systems, patent term extension, as SPC, puts an unnecessary financial burden on health systems jeopardizing universal access in countries where it exists. In view of the restriction of treatment availability for all, the undeniable social cost of expanding pharmaceutical monopoly renders the policy in place of granting SPC both unjustified and unacceptable.

 

This blog post is a preview from a longer article on SPC’s and access to medicines in Europe that will include more in-depth analysis on the legal grounds of SPCs, the flawed justification of SPC as incentives for innovation and the societal cost of the mechanism. The longer version is expected to be published later this year. The research for this article has been done in collaboration with Hu Yuan Qiong and Pascale Boulet.

 

Dimitri Eynikel is an EU Policy and Advocacy Advisor for the Médecins Sans Frontières Access Campaign. In this role he conducts research and advocates for improving access to affordable medicines in countries where MSF has health care projects. He has written this piece in a personal capacity.

 

For more info on the MSF Access Campaign: https://msfaccess.org/

 


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prevention in Europe. 2016. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/pre-exposure-prophylaxis-hiv-prevention-europe.pdf Accessed 23 July 2017.

[v]. World Intellectual Property Organization. Nucleotide analog composition and synthesis method, WO9905150. 1999. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1999005150. Accessed 24 July 2018.

[vi]. World Intellectual Property Organization. Method And Compositions For The Synthesis Of Bch-189 And Related Compounds, WO9111186. 1991. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1991011186&redirectedID=true Accessed 24 July 2018.

[vii]. European Union. Regulation (EC) No 469/2009 concerning Supplementary Protection Certificates for Medicinal Products. Official Journal, 2009. L 152/1 – L 152/10.

[viii]. https://www.lexology.com/library/detail.aspx?g=dba23973-b2d2-4949-8e79-4b73415d8a55

[ix]. Biogaran vs. Gilead, N RG17/09565, Paris Court of First Instance,25 May 2018, the decision is available at: https://drive.google.com/file/d/1uQ1NObCj2EdvGSgs0hwLk1ioabImpqlG/view ; Ref. also The SPC Blog, ‘France – Paris Court of First Instance nullifies Truvada SPC’, 29 May 2018, available at: http://thespcblog.blogspot.com/2018/05/france-paris-court-of-first-instance.html

[x]. The SPC Blog. Germany – Gilead’s SPC for Truvada nullified by the Federal Patent Court. 2018. http://thespcblog.blogspot.com/2018/05/germany-gileads-spc-for-truvada.html Accessed 24 July 2018.

[xi]. Paul M. Gilead loss of generic HIV drug battle a boost for gay community, Irish Times. 2017. https://www.irishtimes.com/business/health-pharma/gilead-loss-of-generic-hiv-drug-battle-a-boost-for-gay-community-1.3284747.  Accessed 24 July 2018; Act-Up Dublin. Gilead versus Generics in Ireland Summary of case and observations from court. http://actupdublin.com/wp-content/uploads/2018/02/Gilead-versus-Generics-Court-Report-171014.pdf. Accessed 24 July 2018.

[xii]. The SPC Blog. Denmark – Gilead successfully enforces its SPC for Truvada. 2018. http://thespcblog.blogspot.com/2018/03/denmark-gilead-successfully-enforces.html. Accessed 24 July 2018.

[xiii]. Mepha Pharma AG vs. Gilead, Swiss Federal Supreme Court, 4A_576/2017, https://drive.google.com/file/d/1Gqni0tDBZ7q8jeaoPbN-B3xzMhxIAY64/view.; English translation https://drive.google.com/file/d/10sQLl4a8lTKgSzMUn61pOl_9uevlBfBT/view Accessed 24 July 2018;  The SPC Blog. Switzerland – Truvada and moving away from the “infringement test” for future SPCs for combination products. 2018. http://thespcblog.blogspot.com/2018/06/switzerland-truvada-and-moving-away.html. Accessed 24 July 2018.

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[xv]. Teva and others vs. Gilead, [2017] EWHC 13 (Pat) Teva vs. Gilead, [2017] EWHC 13 (Pat), England and Wales High Court (Patent Court) decision, 13 January 2017, http://www.bailii.org/ew/cases/EWHC/Patents/2017/13.html. Accessed 23 July 2018.

[xvi]. Ref. Teva vs. Gilead, CJEU case C-121-17.

[xvii] Ref.. Teva vs. Gilead, CJEU case C-121-17; European Medicines Agency. European public assessment reports (EPAR) for human medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 Accessed 11 October 2017.

[xviii].  Zorgintituut Nederland. Database Medicijnkost.nl  https://www.medicijnkosten.nl. Accessed 23 July 2018.

[xix]. Riziv. Database vergoedbare geneesmiddelen. http://ondpanon.riziv.fgov.be/SSPWebApplicationPublic/nl/Public/ProductSearch Accessed 23 July 2018.

[xx]. British National Formula- online https://about.medicinescomplete.com/#/content/bnf/_180330626?hspl=truvada#DMD9098011000001105   Accessed 10 July 2018.

[xxi]. Danish Medicines Agency. Database Medicinpriser.dk. http://www.medicinpriser.dk Accessed 23 July 2018.

[xxii]. Norwegian Medicines Agency. Database Legemiddelsøk.  https://www.legemiddelsok.no Accessed 23 July 2018.

[xxiii]. Ministère des Affaires Sociales et de la Santé. Fiche de presentation Truvada.   http://medicprix.sante.gouv.fr/medicprix/detailPresentation.do?parameter=afficherPresDetail&idPresentation=49800. Accessed 23 July 2018.

[xxiv].  ABDA database http://abdata.de/datenangebot/abda-datenbank/  & Arznei-telegramm® Arzneimitteldatenbank. https://www.arznei-telegramm.de/01atd_info1.php3  Both last visited 10 July 2018

[xxv]. Mymedi.ch Database Medikamentensuche https://www.mymedi.ch/ Accessed 23 July 2018.

[xxvi]. Irish Pharmacy Union. IPU product file. https://ipu.ie/home/ipu-product-file/ Accessed 18 July 2018.

[xxvii]. Pharmaceutisch Weekblad. PrEP verkrijgbaar voor € 50 per maand. 2018. http://www.pw.nl/nieuws/2018/prep-verkrijgbaar-voor-20ac-50-per-maand Accessed 23 July 2018.

[xxviii]. Gilead vs. Mylan, C/17/00048, Dutch-speaking Brussels Court of Commerce, 28 september 2017 https://dimitrismusings.files.wordpress.com/2018/07/ec0af-2017-09-28-vonnis.pdf. Accessed 23 July 2018.

[xxix]. Wilson C. Massive drop in London HIV rates may be due to internet drugs New Scientist. 2017. https://www.newscientist.com/article/2117426-massive-drop-in-london-hiv-rates-may-be-due-to-internet-drugs/. Accessed 24 July 2018.

[xxx]. The SPC Blog. Denmark – Gilead successfully enforces its SPC for Truvada. 2018. http://thespcblog.blogspot.com/2018/03/denmark-gilead-successfully-enforces.html. Accessed 24 July 2018.

[xxxi]. Norwegian Medicines Agency. Database Legemiddelsøk.  https://www.legemiddelsok.no Accessed 23 July 2018.

[xxxii]. Aides. PrEP. 2018. https://www.aides.org/prep Accessed 23 July 2018.

[xxxiii] Aidshilfe. PrEP will soon be available for 50 Euros in Germany, starting in seven cities. 2017. https://www.aidshilfe.de/meldung/prep-will-soon-available-50-euros-germany-starting-seven-cities Accessed 23 July 2018.

[xxxiv]. Mymedi.ch Database Medikamentensuche. https://www.mymedi.ch/ Accessed 23 July 2018.

[xxxv]. The Journal.ie. A HIV prevention drug is being made available to Irish pharmacies at a 70% cheaper cost. 2017. http://www.thejournal.ie/hiv-prep-medication-ireland-3726791-Dec2017. Accessed 23 July 2018.

[xxxvi]. At5. Hiv-preventiepil PrEP na jarenlange lobby in Nederland vergoed, Aidsfonds mist urgentie bij minister. 2018. http://www.at5.nl/artikelen/184165/hiv-preventiepil-prep-na-jarenlange-lobby-in-nederland-vergoed-aidsfonds-mist-urgentie-bij-minister. 23 July 2018.

[xxxvii]. Riziv. Geneesmiddel in PrEp om een HIV-infectie te voorkomen: terugbetaling vanaf 1 juni 2017. 2017. http://www.inami.fgov.be/nl/themas/kost-terugbetaling/door-ziekenfonds/geneesmiddel-gezondheidsproduct/terugbetalen/specialiteiten/wijzigingen/Paginas/geneesmiddelen-PrEp-HIV.aspx#.W0jMyGePXXo Accessed 23 July 2018.

[xxxviii]. NHS. PrEP on the NHS. https://www.iwantprepnow.co.uk/prep-on-the-nhs Accessed 23 July 2018;, Collis H. England’s HIV prevention trial to test generic Truvada. Politico. 2017. http://www.politico.eu/pro/englands-hiv-prevention-trial-to-test-generic-truvada/ Accessed 23 July 2018.

[xxxix]. Pink News. Norway to provide free HIV-preventing PrEP drugs to at-risk gay men. 2016. https://www.pinknews.co.uk/2016/10/20/norway-to-provide-free-hiv-preventing-prep-drugs-to-at-risk-gay-men/ Accessed 23 July 2018.

[xl]. Aides. PrEP. 2018. https://www.aides.org/prep Accessed 23 July 2018.

[xli]. Schwinn M. HIV-Prophylaxe soll Kranken­kassenleistung werden. Süddeutsche Zeitung. 2018. https://www.sueddeutsche.de/gesundheit/prep-spahn-1.4065359. Accessed 24 July 2018.

[xlii]. Aide Suisse Contre le Sida. PrEP.  https://www.aids.ch/en/faq/protection-risk/prep.php. Accessed 24 July 2018.

[xliii].  Finnegan, B. More Affordable PrEP To Be Made Available In Irish Pharmacies. CGN. 2017. https://gcn.ie/affordable-prep-made-available-irish-pharmacies/. Accessed 24 July 2018.

[xliv]. XE currency converter www.xe.com. Accessed 23 July 2018.

[xlv]  Coleman R, Prins M. Options for affordable pre-exposure prophylaxis (PrEP) in national HIV prevention programmes in Europe. Eurosurveillance. 2017;22(42):17-00698. doi:10.2807/1560-7917.ES.2017.22.42.17-00698.

[xlvi]. NHS. PrEP on the NHS. https://www.iwantprepnow.co.uk/prep-on-the-nhs Accessed 23 July 2018;, Collis H. England’s HIV prevention trial to test generic Truvada. Politico. 2017. http://www.politico.eu/pro/englands-hiv-prevention-trial-to-test-generic-truvada/ Accessed 23 July 2018.

[xlvii] Butterworth B. Europe’s largest sexual health clinic launches PrEP service due to huge demand. Pink News. 2018.  https://www.pinknews.co.uk/2018/02/12/europes-largest-sexual-health-clinic-launches-prep-service-due-to-huge-demand/. Accessed 23 July 2018.

[xlviii]. European Parliament Report on EU options for improving access to medicines (2016/2057(INI), 14 February 2017. http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A8-2017-0040+0+DOC+XML+V0//EN. Accessed 24 July 2018.

[xlix]. European Commission. Joint Report on Health Care and  Long-Term Care Systems & Fiscal Sustainability Vol.1’. 2016,  p 139.  https://ec.europa.eu/info/sites/info/files/file_import/ip037_vol1_en_2.pdf. Accessed 24 July 2018.

[l]. European Commission, Innovative Payment Models For High-Cost Innovative Medicines. Report of the Expert Panel on effective ways of  investing in Health (EXPH), 2018.

https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/docsdir/opinion_innovative_medicines_en.pdf Accessed 24 July 2018.

[li]. European Union. Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Official Journal (2016/C 269/06)  23.7.2016. p. 31-36.

[lii]. European Union. Regulation (EC) No 469/2009 concerning Supplementary Protection Certificates for Medicinal Products. Official Journal, 2009. L 152/1 – L 152/10.

[liii]. Kessomboon N, Limpananont J, Kulsomboon V, Maleewong U, Eksaengsri A, Paothong P, Impact on access to medicines from TRIPS-Plus: a case study of Thai-US FTA [2010] 41(3) Southeast Asian J Trop Med Public Health  p. 667-677; El‐Said H, El‐Said M. TRIPS‐Plus Implications for Access to Medicines in Developing Countries: Lessons from Jordan–United States Free Trade Agreement [2007] 10(6)The Journal of World Intellectual Property, p. 438-475; World Health Organization Regional Office of South-east Asia and Ministry of Health. Thailand, Impact Assessment of TRIPS-Plus Provisions on Health Expenditure and Access to Medicines’ (2006). http://apps.searo.who.int/PDS_DOCS/B2072.pdf , Accessed 01 June 2018.

[liv]. Dylst P, Vulto A, and Simoens S. Overcoming challenges in market access of generic medicines in the European Union Journal of Generic Medicines, [2012] 9 (1). p. 21-28. Doi: https://doi.org/10.1177/1741134312441107

[lv] Médecins sans Frontières. Open submission on supplementary protection certificates for medicinal products in the European Union. 2017.  https://msfaccess.org/open-submission-supplementary-protection-certificates-medicinal-products-european-union. Accessed 23 July 2018.

[lvi] Médecins Sans Frontières. Lives on the Edge: Time to Align Medical Research and Development with People’s Health Needs. May 2016. Page 13. Available from: https://www.msfaccess.org/sites/default/files/R&D_report_LivesOnTheEdge_Updated29Sept_ENG_2016.pdf

Collier R. Drug development cost estimates hard to swallow. Canadian Medical Association Journal. 2009;180(3): 279. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2630351

Knowledge Ecology International. Pharmaceutical global R&D was 7.9 percent of sales in 2010. June 2011. Available from: http://keionline.org/node/1152

Pharmaceutical Research and Manufacturers of America. Biopharmaceutical Research Industry: 2015 Profile. April 2015. Available from: http://www.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf

[lvii] Lazonick W, Hopkins M, Jacobson K, Sakinç ME, Tulum O. US Pharma’s Financialized Business Model. Institute of New Economic Thinking Working Paper No. 60. 13 July 2017. Available from: https://www.ineteconomics.org/uploads/papers/WP_60-Lazonick-et-al-US-Pharma-Business-Model.pdf

[lviii] Ibid.

[lix] Ibid.

[lx] Lazonick W, Hopkins M, Jacobson K, Sakinç ME, Tulum O. US Pharma’s Financialized Business Model. Institute of New Economic Thinking Working Paper No. 60. 13 July 2017. Available from: https://www.ineteconomics.org/uploads/papers/WP_60-Lazonick-et-al-US-Pharma-Business-Model.pdf

[lxi] Australia Government. Pharmaceutical Patent Review Report 2013. Pages 64, 67-72. Available from: https://www.ipaustralia.gov.au/sites/g/files/net856/f/2013-05-27_ppr_final_report.pdf

[lxii]. Several studies have been published on the topic by the EC.  European Commission, Supplementary protection certificates for pharmaceutical and plant protection products. 2018 https://ec.europa.eu/growth/industry/intellectual-property/patents/supplementary-protection-certificates_en Accessed 23 July 2018.

[lxiii]. For instance, in order to implement the Comprehensive Economic and Trade Agreement (CETA) with EU Canada had to introduce patent term extension mechanism and adapted a similar system to SPC. Patent term extension has also been proposed in recent EU-Mercosur trade agreement negotiations. Médecins sans Frontières. Briefing document. Trading Away Health in the EU-Mercosur Trade Agreement. 2017. https://msfaccess.org/trading-away-health-eu-mercosur-trade-agreement Accessed 24 July 2018; Office of the Parliamentary Budgetary Officers, Canada. Patent Restoration and the Cost of Pharmaceuticals. 2018,  p. 8, 22.: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/Patent%20Restoration/Patent_Restoration_EN.pdf. Accessed 01 June 2018.

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