With One Exception Current Trade Agreements Do No Appear to Include Biologic Medicines in their Data Protection/Data Exclusivity Provisions – Implications for TPP Negotiation
The U.S., acting on behalf of the U.S. biologics industries, will soon be trying to convince parties to the TPP that they should adopt extended data exclusivity for biologics (at least 12 years) as part of the intellectual property chapter. As part of its marketing strategy, the U.S. is trying to convince parties behind the scenes that biologic data exclusivity is already included in US FTA and indeed in some of the FTA's already binding certain TPP parties. Contrary to this assertion, there is no precedent for data protection for biologics at all in existing US FTAs, let alone for for the extended data exclusivity that the US will be seeking. TPP parties should reject the US data exclusivities as TRIPS-plus, both for chemical entity pharmaceuticals and biologics.
by Brook Baker, Senior Policy Analyst
As reported in the story below [accessible here], South Africa is at long last taking positive steps to reform its overly generous patent law that grants an excessive number of patent on medicines, thereby adversely affecting both affordability and accessibility. This very positive development, largely resulting from a national campaign to Fix the Patent Law launched by the Treatment Action Campaign and Doctors without Borders in 2011, takes place twelve years after the historic Doha Declaration on the TRIPS Agreement and Public Health.
Although the news story reports that S. Africa will adopt a patent examination system and that examination will reduce the number of secondary/evergreening patents, it is hard to assess the depth of the proposed reforms in the absence of access to draft intellectual property policy that was promised months ago. In an earlier draft, the inputs of industry and pharmaceutical-affiliated lawyers were replete, but civil society and independent experts have had not true opportunities for access and input for nearly two years.
TAC and MSF put out a comprehensive release on patent reform on the eve of an IP event hosted by South Africa, WHO, WTO, and WIPO [http://www.fixthepatentlaws.org/?p=630]. The report laid out the essence of the reforms that access-to-treatment activist feel are needed to ensure realization of the right to health. The news report does not address many of their most pressing concerns including tightening up of patentability standards, allowance of opposition procedures, and simplification of compulsory licensing mechanisms among others. Activists would be fully justified demanding immediate release of the draft policy to the public so that informed input can ensure optimal outcomes.
Regrettably Prof. Dean is acting as an apologist for a system that is completely broken and that grants a higher percentage of pharmaceutical patents than even the US and Europe. As a result, S. Africans are burdened not just with patents granting 20-year monopolies on new, break-through medicines, but stacked, successive 20-year monopolies on virtually every kind of minor modification to an existing medicines - new uses/indications, new forms/dosages/formulations, etc. In the absence of a patent examination system in S. Africa, if you file out the applications properly and pay your fees, you can get a patent on peanut butter and jelly sandwiches, then peanut butter and grape jelly, then peanut butter and apricot jelly ad infinitum.
These excessive secondary patents are not cost free - they drive up the cost of medicines and extend the period of monopoly pricing by preventing generic competition. Higher prices, in turn, result in medical apartheid, where the vast majority of patients might be denied access to life-saving, but overpriced, medicines as both medical aides and the government deny coverage because of resource constraints.
South Africa's move to amend its patent laws is not occurring in a vacuum. Brazil will soon launch patent law reforms that are also designed to heightened patent standards and reduce the evergreening of pharmaceutical patents. Zambia and Uganda too are currently considering patent reforms in line with reforms enacted in India in 2005 that have succeeded in greatly reducing the number of secondary patents.
At the same time that countries are belatedly reforming their laws to maximize use of flexibilities allowed under the WTO TRIPS Agreement, which sets forth minimum patent and data protection standards but also allows for nationally-derived flexibilities and exceptions, the US and EU are aggressively pursuing trade policies that would expand intellectual property rights and their enforcement and narrow the use of permitted flexibilities. IP maximalist, often with the support of elements of government, are also supporting a glamour campaign for intellectual property, falsely selling it as the engine of an Africa renaissance.
Contrary to this claim, most credible economic studies show that IP in the continent, and in poorer countries more generally, does not lead to increased foreign direct investment, technology transfer, indigenous innovation, or development.
So a two front battle is being waged - one to enact and then use the limited flexibilities granted under international law for accessing more affordable medicines and another being waged against Big Pharma and Big Power interests that are trying to reshackle African with IP constraints. We must also begin to explore options like those being discussed at the WHO that recognize the failures in research and development and access that are a result of innovation policies wholly reliant on privatizing monopolies on essential public goods like medicines.
Risk Delayed Rollout of Urgent New HIV Treatment Guidelines
(Washington, DC) On Tuesday, 23 July, the Senate’s State and Foreign Operations Appropriations Subcommittee voted to cut funding for the President's Emergency Plan for AIDS Relief (PEPFAR). The widely applauded program is the U.S. bilateral initiative to fight HIV in poor countries that have been hard-hit by the epidemic. The Senate vote is in line with President Obama’s proposed cuts to PEPFAR, and comes on the heels of a similar subcommittee vote last Friday in the House. The full House Appropriations Committee is scheduled to vote on the measure today (Wed 24 July). The funding cuts jeopardize the U.S. Government’s ability to achieve its policy goal to achieve an “AIDS-Free Generation”—a commitment made on World AIDS Day December 1, 2012 and most recently restated in President Obama’s State of the Union Address.
The World Health Organization released long-awaited new HIV treatment guidelines last month that initiate treatment significantly earlier and qualify many more people living with HIV. The new guidelines are the result of scientific findings demonstrating the benefits of earlier initiation to individual patients as well as the powerful impact of HIV treatment to dramatically drop rates of new infections. WHO intends for the new treatment policies to be adopted worldwide, but strong donor support is needed to ensure implementation.
“Cuts in global AIDS support are particularly disastrous less than a month after the launch of new treatment guidelines that could finally bring this epidemic to a close,” said Health GAP’s Paul Davis. “Spending now will save billions in the long run by halting new infections, and this budget is out of sync with science.”
PEPFAR is the largest provider of lifesaving AIDS medication and services in the world, and the funding level proposed by Congress is nearing a record low. The Senate and House Subcommittee votes continue last year's pre-sequester funding level of $1.65 billion for the Global Fund to Fight AIDS, TB and Malaria--an important step for this life-saving international program. However, both voted just over $4 billion for the bilateral PEPFAR program-- $50-$70 million less than Congress passed in the Continuing Resolution for FY2013 last year, pre-sequestration.
“We are grateful that the House and Senate Committees included level funding for the Global Fund to Fight AIDS, TB and Malaria,” said Amirah Sequeira from the Student Global AIDS Campaign. “But reaching the President's promise of an AIDS-Free Generation will require both programs to be fully operational. We can't raid one to fund the other,” she said.
Budget cuts may already be having an impact. "Here in Kenya, more than 600,000 people living with HIV rely on PEPFAR funding for AIDS treatment, but according to a mid-year performance review, PEPFAR has fallen far behind its own targets in the country,” said Maureen Milanga, from the AIDS Law Project in Nairobi. “We had hoped that the U.S. Senate would have voted for the $500 million in additional new funds needed for PEPFAR to pick up the pace and meet its own program goals for an AIDS-Free generation. Don’t leave people with HIV behind. Fully fund your promises,” she continued.
Funding levels for global AIDS could shrink by an additional 7% if sequestration cuts take effect again this session. Health GAP calls on appropriators, House and Senate leadership and the Obama Administration to fully fund PEPFAR at $4.58 billion and the Global Fund at $1.65 billion for FY 2014.
THIS Tuesday (July 23rd), a key Senate Appropriations Subcommittee will determine funding levels for crucial global AIDS programs, and the Global Fund. One Senate Democrat and one Senate Republican will play the leading role in deciding whether the the fight against global AIDS is fully funded at the levels we need in the coming year: at least $4.58 billion for PEPFAR and $1.65 billion for the Global Fund to fight AIDS, Tuberculosis and Malaria.
YOU CAN HELP!
1. Start tweeting ASAP so that Senator Patrick Leahy and Senator Graham know the public has their back if they do the right thing. Tweet, tweet and retweet before tomorrow's 10am committee hearing, and continue on through Tuesday! Please also email out to your friends and loved ones, and share with your Facebook friends!
.@SenatorLeahy @GrahamBlog Pls vots 2 #endAIDS Tues: Lead the fight for $4.58b 4 @PEPFAR + $1.65b 4 GlobalFund! http://ow.ly/ndeXS
2. Bonus points if you make phone calls!
VT Senator Patrick Leahy: (202) 224-4242
SC Senator Lindsey Graham: (202) 224-5972
First, ask to speak to the person in the office who works on "foreign operations appropriations and global healthissues". Record the name of the person you speak with, and jot down their answer.
"My name is __________ and I am calling from ( town, state ) and am a member of ( organization, school chapter, church or service provider). As you've seen previously, science has shown us that increasing the number of people on HIV treatment will turn the corner and bring an end to the global AIDS epidemic, stop HIV infections and give a normal productive life to people already living with the virus. We need you to lead the effort to finish the bipartisan work started by President Bush and continued by President Obama by fully funding PEPFAR and the Global Fund during the upcoming Senate Foreign Operations Appropriation votes. Will you propose and/or vote for $4.58 Billion for PEPFAR and $1.65 Billion for the Global Fund in committee? Creating an AIDS-free generation is a big priority for the US around the world, and for all of us here in my home town."
After you call, email us to let us know! Email this and any questions or comments to Paul Davis at firstname.lastname@example.org
Activists and progressive health forces in Brazil have succeeded in catalyzing a proposal to reform Brazilian patent law to take advantage of key TRIPS flexibilities in order to increase access to affordable medicines. In August 2013, Brazil will issue a major report and proposed legislative reforms that will: eliminate patent term extensions and data exclusivity, restrict patents on new forms and new uses and tighten the the inventive step requirement (following the India example), adopt government use procedures, and clarify the role that ANVISA, its drug regulatory agency, plays in the patent examination system. We hope to gain sign-ons from hundreds of civil society/activist organizations. Please supply the following information and return to me email@example.com.
- Name of your organization
- Contact person's email
This is a very important moment where Brazil can rectify past shortcomings in its patent law and enhance Brazil's ability to meet patients' human right to health. The proposed patent reform demonstrates growing momentum in low- and middle-income countries to maximize use of TRIPS-compliant flexibilities to help ensure access to medicines for all. We believe that the support of global civil society organizations is useful both internally to help support adoption in Brazil and externally to counteract what is certain to be strong negative reaction from the US and EU and Big Pharma.