Implementation of TRIPS Flexibilities In National IP Legislation For Strengthening Access To Medicines In Swaziland Workshop with MOH and stakeholders, Royal Villas, 13 October 2014

Impact of TRIPS on Access to Medicines Wilbert Bannenberg

Patents make medicines unaffordable! Patents create monopolies – Beneficial for R&D companies (in rich countries) – Limited value for Swaziland (mainly importing; very few innovations have been patented) – May affect access to medicines Drug companies use patents to make profits in rich countries Patients in the developing world are a problem: – Ignore the problem? – Sell the original product to them at same/lower cost? – Allow them to use more affordable generics?

Patents and Medicines Patents may be used to delay competition of generic medicines and create a monopoly Without generic competition medicines prices remain high No relation to cost of production and price of patented products – For example sofosbuvir (new for Hepatitis-C): Cost of raw materialUS$ 68 Price per treatmentUS$ 84,000

Patents in developed countries Accepted system to finance Research and Development Health Insurance pays After 20 years, generics enter market, and prices fall dramatically Drug companies try “evergreening” – Get new patents on their profitable medicines – New indication, small molecule change

Swaziland and patents Swaziland does have patents on medicines – UK patents could be granted for Swaziland – IP Office may have granted patents? Patents will make medicines more costly as they block access to more affordable generics As a WTO member, Swaziland needs to apply TRIPS – There are however TRIPS flexibilities to ensure access to more affordable medicines

Swaziland Patent Acts Patents Act 1936 Patents, utility models and industrial design Act 1997 – Did not include all TRIPS flexibilities New process for a Patent Bill 2012 – UNDP assisted – Bill currently in cabinet – MOH requested a workshop to explain background

Why worry about TRIPS? We will need new medicines that will be patented We relied heavily on India producing affordable generics Bad news: India can no longer make generics for newly patented medicines since 2005 – Who will make the generics?? – Swaziland has very limited capacity SADC regional production of new generics?

National Pharmaceutical Policy Patents and Global Trade Agreements: – Limits access to essential medicines Patents and Global Trade Agreements – The objective of the policy in relation to patents is to ensure that legislation and regulations maintain a balance between the minimum standard for intellectual property rights protection and the public health interest. – Review the local patent laws to be in conformity with international property provisions including the protection of traditional medical knowledge. – Protect public health by taking advantage of all the flexibilities within the Trade Related Intellectual Property Right (TRIPS) Agreement that promote public health and ensure access to affordable quality medicines.

Key TRIPS Flexibilities LDC waiver for TRIPS until 2021 – No need to adhere to TRIPS or grant patents Patentability criteria – No need to allow new/2 nd use patents (TRIPS+) Parallel import – Buy the patented product in another country Compulsory licenses / government use – 30 August 2003 waiver: CL for export Research exemption Early Working (Bolar clause): early approval of generics No need to provide data protection in drug regulation

2001 WTO Doha Declaration on TRIPS and Public Health 4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

Non-TRIPS measures Voluntary licensing Medicines Patent Pool (MPP) for ARVs – Swaziland can benefit from MPP licenses and source medicines for the treatment of HIV and Hepatitis-B (Tenofovir) from generic producers that have sublicenses from the MPP.

Swaziland best uses a strategy to: Enter only the minimum required of TRIPS in Patent Law Maximize the permitted public health “flexibilities” Fully use the TRIPS flexibilities Avoid TRIPS+ measures (bilateral trade agreements) Watch out for “anti-counterfeiting” laws making generics illegal

Questions? Workshop with MOH and stakeholders, Royal Villas, 13 October 2014

Examples: 2 nd or 3 rd line ARVs, TB, hepatitis and cancer medicines

Swaziland’s epidemics Infectious diseases – HIV/AIDS: need for 2 nd or 3 rd line ARVs (in future) – Tuberculosis: need new drugs for MDR/XDR-TB – Hepatitis-B and C? Non-communicable diseases: – Cancer: expensive medicines – Diabetes – Cardiovascular: high blood pressure, stroke We will need new medicines in the future

Anti-retroviral therapy in Swaziland 190,000 HIV+ 38,164 Pre-ART enrolled 96,113 in need of ART 87,543 people alive and on ART (Dec 2012) – comprising 7,431 children and 80,103 adults – 75,810 people were on 1 st line ART regimen – 1.6% (1,213) were on 2nd line ART regimen (source: 2012 ART report)

From D4T to TDF

Remember how South Africa got affordable generic ARVs? Antiretrovirals were unaffordable in 1997 – $ pp/year due to the patents of big pharma – Brazilian/Indian generics cheaper ($900, then $360, now $62) – But generics could not be imported due to patent barriers SA made a law to make patented medicines cheaper – 39 drug companies sued Nelson Mandela SA eventually got access to generics in 2001 – AIDS activists (TAC) testifying in court, public pressure (MSF) and a Competition Law case (AIDS Law Project) – Patents are valid in SADC but not enforced

New 1st line ART using tenofovir Tenofovir –based regimen better than stavudine However: costly as it is patented in ARIPO and SA MSF pioneered tenofovir in Lesotho at high cost Manufacturer Gilead allowed 7 generic companies to make tenofovir under voluntary licence Generic competition dropped the price We have generics – while the patents are still valid!

Tenofovir price now $26pp/year

Other useful but patented medicines... 2 nd and 3 rd line antiretrovirals New curative treatment for hepatitis-C New drugs for MDR- and XDR-TB Non-communicable diseases: – Cancer medicines – Diabetes, – Cardio-vascular: hypertension, stroke Not sure that drug companies will allow generics! – India since 2005 TRIPS compliant – Cannot easily make generics anymore

Example: South Africa faces expensive medicines due to patent barriers South Africa grants ALL patent applications without substantial examination Allows 2nd use patents / evergreening Has a TRIPS+ Patent Law Is not using its TRIPS Flexibilities MSF, TAC and Section27:

Cancer medicines 14m new cancers discovered globally – 8.2m die per year – Fastest increasing money maker for big farma Swaziland: cancer increasing 14 anti-cancer medicines on EML – All gnerics; none of the new anti-cancer medicines Some anti-cancer medicines are becoming available as generics in India – Important to check status of cancer medicines in Swaziland

Effect of Secondary Patents Cancer drug Imatinib Mesylate Patents: Evergreening Trend (2013) (2017) (2022) Imatinib and all its salts patented. (This patent expired in SA 2013) Mesylate salt of imatinib patented New Use of Imatinib (GIST) Patented Granted in S. Africa MSF Access Campaign Treatment Action CampaignSECTION27

Hepatitis-C virus (HCV) 185 million people across the world are infected with HCV; 150 million are chronically infected. The HCV pandemic is concentrated in middle-income countries (MICs) – 15% of the 150 million people with chronic HCV live in high- income countries (HICs), – 73% live in MICs – 12% in low-income countries (LICs). It is estimated that HCV-related liver complications kill 350,000 people annually. Until recently treatment was cumbersome and not very effective (interferon, ribavirin) Swaziland has ? (10,000?) cases of HCV

DAAs: a cure for hepatitis-c Hepatitis-c can now be cured by taking 2 new directly acting antiretrovirals (DAA) for 12 weeks – No need to take it life long (like ARVs) Stops progression to liver failure and liver cancer Example: Sofosbuvir by Gilead (also makes tenofovir) – Oops – 1 tablet costs $1000 – So a cure (to survive) costs > $84,000 – Difficult discussions in USA, Europe: can we afford? – Swaziland: 10,000? x $84,000 = $840 million... Egypt, Mongolia got 99% discount: $900 per course Can we get generics? – Raw material cost only $68 per course

Access Scenarios Originators lower the price to a level Swaziland can afford Originator grants voluntary licenses/ Medicines Patent Pool to generic manufacturers - Swaziland part of territory Patent not granted in India – Patent not granted in Swaziland -> import from India – Patent granted in Swaziland -> issue a Government Use licence - > import from India Patent granted in India -> Section 92(A) Indian Patents Act: CL for export to Swaziland – Patent granted in Swaziland -> issue CL/GU SADC regional procurement -> larger orders to benefit from economies of scale – re-exportation from Swaziland to other SADC countries

Needed: a new SADC strategy for regional production or importation of new generics TRIPS poses A2M problems in SADC and India – But, solutions exist for all TRIPS barriers But, someone has to make the new generics – India (under CL for export), imported by SPPS and MS – Can we make them in SADC? This needs a new SADC strategy! – Need for market shaping (who makes what?) – Technical and financial support – WHO prequalified manufacturing site – Harmonised Regional Regulatory approvals, etc

Non-patent barriers for Access to Medicines Poor policy or political will High prices, low drug budget, no insurance system Procurement challenges Quality issues Overuse, misuse Market failure

Questions, answers and discussion Workshop with MOH and stakeholders, Royal Villas, 13 October 2014