3rd Global Congress on IP & Public Interest Cape Town, SA, December 2013

Intellectual Property Rights & Access to Medicine A Patient Perspective

Malaysia Facts 100,000 PLHIV reported cases by end of 2013, Malaysian Ministry of Health Malaysia issued government use licenses valid for two years. Monthly treatment cost of the government hospitals and clinics fell by 81% from USD 325 to USD total 16,000 patients received ARV therapy. Not enough – 37,305 patients are in need of needed urgent treatment (CD4 counts below 350 cells), national treatment guidelines.

The question is Life or Death ???

New treatment and drugs prolong our lives “For PLHIV, we need life-long treatment. For us, it is a matter of life and death. So we call for a halt to these FTA negotiations because without affordable and accessible medicines, more of us will die.” Edward Low of MTAAG+.

Reproductive Health & Rights

Regional concerns of APN+ “The ink on the UN Declaration is not even dry. The Declaration clearly recognizes that intellectual property can be a barrier to access to medicines. Everything in the history of the AIDS epidemic testifies to this. Over 80% of those on AIDs treatment in poor countries are taking generic treatment. And yet the United States is pushing even greater legal barrier to generic treatment.” Mr. Shiba Phurailatpam of APN+.

Concerns of Vietnamese “PEPFAR itself switched to generic ARVs that were more affordable. PEPFAR’s own procurement and supply of generic ARVs in Vietnam is at risk and threatens to increase expenditure significantly. Does the left hand of the US government know what the right hand is doing?” Do Dang Dong of the Vietnam Network of People living with HIV.

What is a generic medicine?

Doha Declaration “We affirm that the (TRIPS) 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.” WTO Ministerial Declaration on the TRIPS Agreement and Public Health November 14, 2001

11 India: Pharmacy of the Developing World Generic Competition Drops HIV Drug Pricing by 99 Percent

TRIPs flexibilities provide access to disabled & seniors citizens

Where people have gone ?

TRIPS plus provisions killed them…

Evergreen patent. Hemisulfate salt. Composition for paediatric use. Another 20 years. Patent police for drug regulatory authority.

Protest 2 nd round talks EU-Malaysia FTA in K.L

Submission & dialogue with EU officer.

Protest 4 th round talks EU-Malaysia FTA at MITI.

Submission to Karel De Gucht,European Trade Commissioner.

TPP Slated to Expand Across Asia-Pacific Region

TPP Negotiating Rounds Next: Round 15: Auckland, Dec 3-12, (Strategy planning ?) Previous: Round 14: Leesburg, VA, Sep 6-15, 2012 Round 13: San Diego, CA, Jul 2-10, (Health groups join statement) Round 12: Dallas, TX, May 8-18, 2012 Round 11: Melbourne, Mar 2-9, 2012 Round 10: Kuala Lumpur, Dec 5-9, (Mobilized communities to protest) Round 9: Lima, Oct 22-29, (Presented in Stakeholder Forum) Round 8: Chicago, Sep 6-15, 2011 Round 7: Ho Chi Minh City, Jun 15-24, 2011 Round 6: Singapore, Mar 24-Apr 1, 2011 Round 5: Santiago, Feb 14-18, 2011 Round 4: Auckland, Dec 6-10, (Submission to USTR) Round 3: Brunei, Oct 4-9, 2010 Round 2: San Francisco, CA, Jun 14-18, 2010 Round 1: Melbourne, Mar 15-19, 2010

22 The U.S.’s TPP Position Undermines Its Own Global Health Commitments The U.S. has made an AIDS-free generation a policy goal… Without continued access to new affordable generic drugs, an AIDS-free generation will be unattainable BUT continues to pursue trade policies that will restrict access to affordable life-saving drugs…

23 The U.S Congress “So why in the face of this success by one arm of our government would another arm work to pull the rug out from underneath it? Yet the United States Trade Representative's office is doing just that.” Senator Bernie Sanders, Senate Speech on Unfettered Free Trade

5 th round talk TPP at Santiago, Chile. Submission of memorandum & Valentine Card to Prime Minister’s Office on 14 th, Feb 11.

Submissions 19 th, Dec 10. Asia Pacific Regional Dialogue. Global Commission on HIV & the Law. 21 st, March 11. The Special Rapporteur for the U.N on the right of everyone to the enjoyment of the highest attainable standard of health. 5 th, May 11. Ministry of International Trade & Industry (MITI) for IP consultation. 3 rd, Feb 12. Human Right Commission of Malaysia.

Health Groups Joint Statement

Response from Health Minister "We are against the patent extension. According to the agreement, if a medicine is launched in the US, and then three years later it is launched in Malaysia, the patent would start from when it is launched here and not when it was launched earlier in the US," said Liow. "This is not fair." 6 August 2012

Investment State Dispute Settlement (ISDS) Liow also stressed that a company should not be given the power to sue a government due to its state policies. 6 August 2012

We would like to call on the governments to fully implement and use all TRIPS flexibilities in their patent regimes. For example: to increase the use of compulsory licenses. to not agree to any TRIPS+ intellectual property IP standard such as data exclusivity and patent linkage. to promote the local generic industry & technology transfer.

We request from the national governments of the other TPPA Signatory countries to come together & refuse to accept any further restrictions on production, registration, supply, import or export of generic medicines; to launch Asian- Pacific collaboration on an urgent basis to put in place a sustainable, affordable pipeline of generic medicines for future generations; and to call for an immediate review of TRIPS & its impact on access to medicines in developing & least developed countries.

We request from Malaysian Parliament & Constitutional Bodies to immediately request the TPPA negotiating texts; review their impact on the right to health & access to medicines; refuse to endorse or ratify the Agreement that would be signed with provisions that undermine our people’s right to access affordable treatment; and review Malaysian laws including patent and medicine regulatory laws and policies to ensure all aspects and elements of the Doha Declaration are in these laws.

Resolution The European Parliament resolution of 12 July on the TRIPS Agreement and access to medicines called on the European Council to refrain from negotiating “TRIPS-plus” provisions including specifically data exclusivity provisions.

No to TRIPS plus provisions!!!

Thank You !!! Edward Low Director, Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)