How do patents affect prices?

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1 How do patents affect prices? Patent No patent One supplier Multiple producers No competition Competition High prices of imported medicines Access to low cost generic medicines

2 How to bring down prices? Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012

3 What is Evergreening?

4

5

6 What Reforms Could SA Enact? Other countries have used these reforms to make their patent systems work in the interest of public health: Stricter patentability criteria Patent search & examination system Patent opposition Broad research exception Improve Compulsory Licensing & Parallel Importation mechanisms Publicly financed R&D, de-linkage principles The Dept. of Trade & Industry released a Draft National Policy on IP for public comment in September 2013, expressing the need for most of these reforms. A closer look

7 Economic cost Pharmaceuticals are 5 th largest driver of SA trade deficit / R5billion spent on procuring pharmaceuticals by DOH in 2012 Cost driven by branded products despite the fact that in quantity the majority of medicines are imported from India and majority of API from China. Every Rand spent on branded medicines is money diverted from the wider health system

8 Related work: Regulatory Reform Recommendations for Medicines and Related Substances Amendment Bill: S15(2)b: Specific timelines of registration (6 months) for priority treatments, with explicit penalties of Authority for non compliance S 21: Formally allow Section 21 exemption on the grounds of affordability restricting access to life saving treatments S 22: Require the Authority to make public the date of application submission, name of medicine in question, expected price and current status of application S 2B(2)(a): Other Stringent Regulatory Authorities findings can be utilised in order to speed up registration

9 MSF started including linezolid in strengthened regimens of DR-TB patients in month supply of Pfizer product cost over R123,000 per patient Pfizer product under patent in SA until August 2014 Globally, more affordable generics receive quality approval from stringent regulatory authorities from mid-2013 Source Cost (per pill) Comment Pfizer originator USD month course = USD South Africa Antibiotic Tender (now expired) Hetero (generic manufacturer) Linezolid: IP and Price Challenges USD27 USD8 Pfizer has not bid on TB drugs tender MSF price--not yet available in South Africa

10 South Africa pays the price

11 Linezolid Redux?: New DR-TB drugs Bedaquiline US FDA Approval in 2012 SA registration fast-tracked in Dec approved Oct Clinical access program recently ended following full registration limited number of sites. Wider national rollout planned (goal of 3,000 patients in 2015) SA price unknown but lowest announced price for any country $900 for a course of treatment At least 4 patents granted in SA (expire between ) including use for treating DR-TB in combination with other TB drugs Delamanid Registered by the EMA in 2013 Will Otsuka register in South Africa? At what price? At least 7 patents in SA (expire between ) including on use with other TB drugs **Will combination patents hinder research into better regimens??**

12 Unaffordable Why are some medicines so expensive?

13 Cancer drug Effect of Secondary Patents Imatinib Mesylate Patents: Evergreening Trend (2013) (2017) (2022) Imanitib compound 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

14 Before generic competition in SA

15 Imatinib: Still Priced Too High Novartis charges 39% less in India than in SA Cipla s price in India is 91% less than in SA Least expensive option: Cipla in SA is almost 20 times more than Glenmark in India Manufacturer India ppy (ZAR) South Africa ppy (ZAR) Novartis R 237,549 R 387,834 Cipla R 17, 816 R 208,780 Sun Pharma R160,982 Natco R 20, Glenmark R 10, Will further competitors (and lower prices) be blocked in South Africa by Novartis secondary patents?

16 How many times do we pay? Novartis Gleevec: 1. Early Research Costs: 50% National Cancer Institute 30% Leukemia and Lymphoma Society 10% Oregon Health Sciences university; Only 10% Novartis 2. Tax Credits: Orphan Drug Credit for Novartis 3. Product costs: Sales of Gleevec in 2012: $4.6 billion Estimated Novartis Investment in R&D: $38-$96 million Full return on investment every 13 days!!!

17 Aripiprazole Aripiprazole - anti-psychotic (for schizophrenia, bipolar disorder) one of the top-10 selling drugs globally Could have been off-patent in U.S. in 2009 (extensions run to 2015) South African multiple pending patents (Otsuka, BMS) could run until Cost of a 10mg tablet R35.60 in South Africa over 35x higher than generics available in India. SA price (R3.56/mg) 20% higher than in Japan (R2.84/mg) If SA had India s prices, over R29 million in savings annually that could be realized on one drug alone

18 Oral contraceptive (DSP+EE) Bayer holds multiple patents on drospirenone clathrate/ethinyl estradiol (Yasmin/Yaz). Initial Yasmin patent expired 2011 in SA, secondary patents expire 2022 (size of synthetic hormone) and 2024 (dissolution profile). Ruby is a generic version of Yasmin, by manufacturer Pharmadynamics

19 Oral contraceptive (DSP+EE), continued Pharmadynamics 2011 launch of generic product at ~30% lower price was halted through an interdict over secondary patent SA court case continues, even though generics available elsewhere, patent in question has been struck down in Europe and US. Secondary patents on Yasmin run to 2024 Pharmadynamics has incurred over R10million in legal fees, millions of rand in lost sales will make it difficult to realize lower prices even if they are given right to launch product

20 Oral contraceptive (DSP+EE) Sales Manufacturer Brand Name Units Sold in SA (Oct Sept. 2013)^ Annual revenue in ZAR (Oct Sept. 2013)^ Price per pack of pills in private sector* Bayer Yaz R Bayer Yasmi n R Ruby 0 0 R80.93 Pharmadynam ics If everyone on Yasmin had made the switch to Ruby, South African women would have saved over R11 million per year in total.

21 Entecavir for Hepatitis B Hepatitis B chronic infection affects approximately 8% of the population in Sub-Saharan Africa Entecavir used for those who don t tolerate tenofovir, have kidney impairment. Not available in public sector, nor on private formularies for HepB R4,700-R5,500 per month in SA (Bristol-Myers Squibb only manufacturer). In India, generics cost around R400-R800 per month! Initial patent expired 2011 in SA. Three secondary patents were granted, one still in force (expires 2022). Patent overturned in the U.S. can be filed in SA up until end 2014

22

23 How can we strengthen the campaign? Organisations endorse/sign up to campaign Encourage patient voices Find/be an expert doctor to be campaign spokesperson Join public actions, meetings with decision makers, conferences Sign on to letters, parliament submissions, petitions, social media actions, etc. Feedback on ideas (e.g. poster) Google group to share activities, open source campaign materials Other ideas?

24 Thank you!

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