Returning to Durban, South Africa for the International AIDS Conference sixteen years later, the issue of high drug prices remains front and center. First generation antiretroviral medicines remain accessible and affordable in most low- and middle-income countries and some people in some regions have access to low-priced second-generation medicines because of voluntary licenses and discounted prices. But millions of people with HIV and their governments, especially in middle-income countries in Asia, Latin America, Eastern Europe and Central Asia, and in the Mideast and North Africa, face antiretroviral drug prices that are exclusionary because of drug monopolies. And yet, people with HIV have better access than most – our brothers and sisters living with cancer, hepatitis, mental illness, and other treatable health conditions face unrelenting intellectual property barriers. Meanwhile, the Indian generic industry - often referred to as "the pharmacy of the developing world" - is under threat.Read more
Last week, the United States government reached new heights of hypocrisy when, in its speech to the UN General Assembly at the United Nations High-level Meeting on Ending AIDS, it claimed to support affordable access to medicines in one breath but, with the next, adopted Big Pharma’s talking points almost verbatim and attacked efforts by other governments to ensure affordable access to medicines.Read more
by Brook Baker, Health GAP Senior Policy Analyst
Originally posted on InfoJustice.org
This paper provides a detailed analysis of the effective geographical scope of the recently announced adult and pediatric between the Medicines Patent Pool and ViiV Healthcare covering dolutegravir. an important integrase inhibitor. In addition to providing a comprehensive analysis of the effective geographical scope of the licenses, taking into account both the formally licensed territory and territories where ViiV patent rights would not be violated by sales of dolutegravir, the paper also analyses other key aspects of the licensing agreement.
Although the effective geographical scope is broad, it is not as inclusive of middle-income countries as desired (coverage 93.4% for adults, 99.3% for children). Excluded countries and their supporters should demand inclusion, but even in the absence of voluntary action by ViiV, countries can use oppositions to pending and granted patents (where available) or compulsory licensing to gain access to this medicine and its combination with other ARVs.
US's "new" proposed TPP IP Chapter still requires patents on medicinal forms with "distinguishing features"
by, Prof. Brook K. Baker, Health GAP
Feb. 7, 2014
IP, health and trade activists expressed outrage in early 2011 when the proposed US IP Chapter for the Trans-Pacific Partnership Agreement was first leaked. Particularly concerning was the language of section 8.1, addressing standards of patentability, that that proposed a substantial weakening of patentability criteria, including required patenting of new forms and new uses of existing medicines: "[T]he Parties confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the know efficacy of that product."
Other TPP negotiators were reported to be uniformly opposed to the U.S. proposal and the unconfirmed reports 2012-13 were that the U.S. had dropped its demand that new forms be patented.
The Wikileak disclosures of more recent IP chapter positions has revealed that the US has not so much dropped the demand that patents be granted for new forms, but rather has hidden the same demand in new language: “The Parties confirm that: (a) patents shall be available for any new uses or methods of using a known product and (b) a Party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.”
The identical language in both US proposals is that TPP members would not be permitted to assess enhanced efficacy in determining whether an alleged invention is patentable. This provision is a direct challenge to section 3(d) of India's Amended Patents Act, which was famously used by the Supreme Court of India to deny Novartis's application for a patent on Glivec. Section 3(d) has been used in other opposition proceedings and decisions of the Indian Patents Office to deny secondary patents on minor variations to existing medicines where the variations do not evidence significantly enhanced efficacy in treating humans (not just in terms of physical properties like stability). Other countries are beginning to mimic the Indian provision, e.g., the Philippines, and comparable reforms are being proposed in important pharmemerging markets including Brazil and South Africa.
But in other respects, the new section 8(1)'s language concerning products with "distinguishing features" is linguistically equivalent to the earlier version concerning "new forms." Something new is something that is distinguishable from what existed before. Thus, many of the unpatentable new forms specified in India's section 3(d), e.g., "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance" would have "distinguishing features" under the US proposal and thus be patentable.
IP maximalist positions in US TPP proposals never go away. The only patent demand that seems to firmly have been dropped is the US position outlawing pre-grant opposition procedures. The US is also reported to be proposing a transition period for Vietnam, Peru, Mexico, and Malaysia with respect to some of its patent and data monopoly demands, but that freedom will be temporary and partial.
Granting patents on new forms of existing medicines – or under the new language on forms with distinguishing features – is the essence of low/weak patent standards that results in evergreening – successive and recursive patenting of a medicine to extend the period of monopoly protection. TPP trading partners should continue to reject this US proposal or their access to affordable generics will be seriously constrained.
By Professor Brook K. Baker
Senior Policy Analyst, Health GAP
January 17, 2014
PhRMA (Pharmaceutical Researchers and Manufacturers of America) is putting $350,000 on the table to stop proposed patent law reform in South Africa and instead to lobby for even more monopoly protections for medicines. Why would a pharmaceutical association from the US be so interested in an African country that comprises only a tiny fraction of global pharmaceutical sales? Why, after having faced universal public scorn for having sued the Nelson Mandela government 1998-2001 to stop earlier, completely lawful access-to-medicines reforms, would the industry once again risk humiliating publicity and an all-but-certain defeat? More particularly, when every reform that South Africa is proposing is completely lawful under international intellectual property law, most particularly the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), why would PhRMA choose to a clandestine, public-relations and think-tank strategy not only to derail the propose reform, but advocate for even stronger monopoly protections?
The answer is simple – dirty lucre and precedent.
The current South African patent regime is a PhRMA dream. Although South Africa has legislation mandating patent examination, an examination system has never been established. This means that virtually every drug company patent filed in South Africa, so long as the applicant can fill out the form and pay the filing fee, will be and is granted. No one – I mean no one – double checks whether a patent application has any merit whatsoever. No one checks if alleged innovation is in fact new or well known under existing industry practice. No one checks if the patent application impermissively makes numerous claims or duplicates claims made previously. Pfizer could get a patent on a peanut butter and jelly sandwich tomorrow if it wanted to.
PhRMA also likes the South African patent regime because it doesn’t allow anyone to come in and oppose a patent application even if it has not merit. PhRMA likes the SA patent regime because it’s so cumbersome to get a compulsory license that no such license has ever been issued. Ditto with respect to parallel importation (buying a brand drug more cheaply in another country and importing it when excessive prices are imposed domestically.
What PhRMA doesn’t like about the proposed SA reform that SA Draft IP Policy recommends: (1) tightening up patenting standards, (2) examining patent applications vigorously, (3) allowing other parties to oppose patent applications, (4) limiting patent terms to 20 years only, no extensions, (5) disallowing monopolies based on data/registration exclusivity and patent/registration linkage, and (6) adopting easier to use parallel importation and compulsory license mechanisms. Each and every one of these provisions is lawful; each and every one is acknowledged by international bodies including WIPO, the WTO, UNDP, UNAIDS, WHO and others; each and every one is a wise exercise of public authority that – in accordance with the Doha Declaration on TRIPS and Public Health – prioritizes public health and access to medicine for all.
Instead of these commonsense, lawful, and indeed modest reforms, the united pharmaceutical industry wants to push for “stronger” and more “comprehensive” IP protections – IP that produces stronger, longer, and broader monopolies, monopolies that exclude competition and allow unfettered monopoly profits.Certainly PhRMA is interested in extra monopoly profits to be made in South Africa, but it is interested in monopoly profits in Africa more broadly and in so-called pharmemerging economies where the bulk of its future profit growth will come from. In other words, PhRMA and the consulting firm it is hiring, Public Affairs Engagement, are worried about South Africa as a precedent:
If the principles in the draft [IP Policy] are adopted, not only will South Africa become less hospitable to the Life Sciences sector, it may also provide the model for other developing nations, inside and outside Africa, including such important aspiring economies such as India and Brazil.
South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate. … A robust public affairs program is necessary to create the environment for a sensible IP policy to be adopted by the Cabinet and implemented through legislative processes. … Without a vigorous campaign, opponents of strong IP will prevail – not just in South Africa but eventually in much of the rest of the developing world.
Strong patent rights are the goose that lays the golden eggs for Big Pharma worldwide. For PhRMA, the movement for pro-health reform – the fox in the goose house – must be crushed. The precedent must be defeat, not victory.However, PhRMA does not intend to argue its case on the merits. It plans a disinformation and closed-door lobbying campaign full of lies and innuendos. First and foremost, it plans to argue that IP reform will retard domestic and foreign investment and that stronger IP will open the doors to investment, growth and development. However, if easy patents were good for South Africa, it should be awash in investment now, since it is virtually impossible not to get any patent you want in South Africa today. Indeed, all available evidence shows that stronger IP has not positive correlation with increased investments in South Africa or any other African or lower-income country. But, it isn’t evidence or logic that PhRMA wants to sell – it’s fear.
Second, PhRMA plans to sell fear of competition, most notably from Nigeria, Africa’s other economic powerhouse. Somehow, according to the planned obfuscation game, Nigeria will leap ahead of South Africa if South Africa simply adopts internationally acknowledged IP standards, including fully lawful flexibilities allowing countries to bypass patents to respond to public health needs and to overcome monopoly abuses. It doesn’t matter that Nigeria has poor infrastructure, under-developed human capacity, and the lack of a technological base – all it needs is for South Africa to adopt IP reform and its economic transformation will be complete.
Third, PhRMA wants to argue that “South Africa’s health problems are the result, not of lack of drug access, but of poor health infrastructure, improper management, and, ultimately, poverty.” Here, PhRMA’s not lying per se, but it is guilty of implicature – the half truth that tells a lie. Perhaps PhRMA can explain why excessive drug prices miraculously improve health systems and management. Better yet, maybe it can explain how exorbitant prices cure poverty!
But PhRMA’s shill, the PAE, makes clear that “we do NOT want a debate over individual drug prices to become the focal point of the campaign.” Well, one can certain understand that – just because high prices are the most fundamental feature of the IP regime, why would PhRMA want anyone to talk about that?
Although PhRMA plans to ally with local proxies like the Innovative Pharmaceutical Industry Association of South Africa, SA business groups, and compliant academics, the campaign will be run from Washington. Operating under a euphemism like “Forward South Africa” and ostensibly led by a “respected former government official, business leaders, or academic,” the publicity and intense lobbying campaign would be actually be run by US-based PAE, which promises that “any and all research, op-eds, blog posts, and other material” will be reviewed and commented upon by PhRMA. PAE promises to consult with PhRMA every step of the way.
Big Pharma was shamed in front of the whole world over its 1998-2001 lawsuit against South Africa that used a phalanx of lawyers to try to defeat TRIPS-compliant parallel importation and generic substitution. Tail between its legs, the 39 drug companies and pharmaceutical association that sued Mandela finally withdrew their case following a deluge of negative press in March of 2001. PhRMA, on behalf of that same industry, is now bearing its fangs again, but will use misleading studies, op-eds, and threatening lobby visits to delay and even reverse pro-health reform. Fortunately, the global press and treatment activists are lifting the curtain and shining a spotlight. But it will take concerted effort to win this pro-health campaign against a US-dominated industry that over and over again cries crocodile tears about poor peoples’ health while gouging their governments for every last penny of monopoly profit.
Contact: Brook Baker: +1 617 259 0760 * [email protected]
Paul Davis: +1 215 833 4102 * [email protected]
Medicines Patent Pool agreement with Bristol-Myers Squibb expands access to critical second-line AIDS medicine, even while BMS excludes some middle-income countries. More companies should join the Pool and offer expanded geographic coverage.
Health GAP applauds the announcement of a new licensing agreement negotiated by the Medicines Patent Pool with Bristol-Myers Squibb (BMS) for a key second-line protease inhibitor, atazanavir (ATV). Although the official territory is comprised of 110 low- and middle-income countries, a key clause allows generic licensees to sell without obstacles in another 34 countries where no ATV patent is in force. In addition, generic licensees will be able to supply countries that issue compulsory licenses. The new agreement effectively extends coverage to many more people with HIV than the prior 49-country deal BMS had previously confidentially negotiated with three generic licensees.
The scope of the license covers nearly 90% of people living with HIV in low- and middle-income countries, but the remaining 10%, who live in middle-income countries, are still not covered. Some of the excluded 10% are left without coverage because they fall under a separate bilateral agreement made between BMS and the Brazilian Government. People living with HIV need 100% coverage and thus urge the MPP, BMS, and other MPP licensors like Gilead to expand geographic coverage.
“Companies with existing MPP agreements should commit to expanding coverage,” said Professor Brook Baker, Senior Policy Analyst for Health GAP. “But it is also essential that other companies with critical new medications enter into open-access licenses with the Pool and ensure coverage for all low- and middle-income countries. This is particularly urgent for ViiV, whose majority shareholder, GlaxoSmithKline is demanding extremely narrow coverage for dolutegravir. Abbvie should open access to lopinavir and ritonavir separately so that ritonavir can be used as a booster with ATV and other protease inhibitors. Also, Merck and Johnson & Johnson, the last two hold-outs, must speedily license their HIV drugs,” said Baker.
“Achieving an AIDS-Free Generation requires expanding access to better ARV treatment regimens, and that depends on a critical mass of companies joining the Medicine Patent Pool with overlapping territories. There is urgency with respect to existing WHO-recommended regimens, but we also demand rapid access to critical new, improved ARVs like dolutegravir and tenofovir pro-drug," said Paul Davis of Health GAP.
“People with HIV in low- and middle-income countries have a right to expedited access to the latest treatments that are more effective, longer lasting, and have fewer side effects. Many of the ground-breaking new medications will be much, much cheaper to produce because they contain simpler molecular structures and lower amounts of active ingredients,” said Health GAP’s Maureen Milanga in Nairobi. “We need GSK and Merck to speed up talks with the Patent Pool for game-changing new products like TAF and DTG.”
“Governments that aren't included in MPP licenses should issue compulsory licenses and use all other public health flexibilities that are part of the WTO’s TRIPS Agreement,” stated Health GAP’s Asia Russell. “Such options will have a much more positive impact on affordability and access than industry-oriented proposals such as tiered-pricing initiatives.”
By Brook Baker, Health GAP Senior Policy Analyst
On December 11, the Medicines Patent Pool announced a new licensing agreement for a 2013 WHO recommended second-line antiretroviral, atazanavir (ATV). At this point, it is important for IP activists, generic companies, and countries to understand both the express territorial coverage of the license (110 countries) and its “effective” territorial coverage as well (144 countries plus the possibility of compulsory licensing expansion). Because royalty payments are actually limited to situations where granted patents are in effect – and with some exceptions even then, it is also important to identify the limited circumstances where royalties will be imposed. Finally, it is important to analyze some of the licensed or patent-free availability or ritonavir or cobicistat for co-formulated boosting. Download the full analysis here.
Nov. 27, 2013, By Brook Baker
Inside US Trade and the USTR have announced that the U.S. is floating new proposals on IP in its marathon Trans-Pacific Partnership Agreement negotiations. Although the U.S. touts its new proposals as being balanced, as prioritizing access to medicines, and as recognizing the interests of developing country negotiating partners, particularly, Peru, Vietnam, Mexico, and Malaysia, its actual proposals offer modest temporary respite at best from only a small fraction of U.S. demands.
The U.S. is essentially sticking by all of the demands revealed in the latest Wikileak disclosures, except with respect to its grudging acceptance of pre-grant oppositions (it had previously given up demands for mandatory patents on new forms of existing medicines). Required patents for new uses, required granting of patents on medicines even in the absence of improved therapeutic effects, data/regulatory monopolies on clinical trial data (data exclusivity), mandatory patents on virtually all medical, surgical, and diagnostic procedures, enhanced damages for patent infringement, mandatory injunctions, and stronger border measures will all be mandatory the minute the TPP is signed. Even more ominously, IP will remain in the investment chapter, meaning that drug companies will immediately be able to sue TPP members if the companies' expectations of IP-based profits are thwarted by fully lawful legislative, regulatory, or judicial decisions.
Even more ominously, as soon as countries cross a threshold of $12,616 GNI per capita - roughly fourth of the U.S. figure, they will be required to grant patent term extensions to compensate for regulatory delays, to allow ever-greening of data exclusivity without any explicit public health safeguards, and to require drug regulatory authorities to act as patent police through registration-patent linkage. Malaysia and Mexico are already nearing the upper-income thresholds with GNIs per capita of $9810 and $9740 respectively in 2012. Peru is half-way there with a per capita GNI of $5880. Only Vietnam will achieve any real temporal breathing room with a per capita GNI of $1400, barely lower middle-income. Accordingly, current middle-income country partners - as soon as they cross that World Bank threshold and become "upper-income" - will be bound by the highest level of patent and data monopolies ever proposed in trade negotiations.
In terms of actual "concessions", the U.S. has given very little except what was already on the books in the May 10, 2007 New Trade Policy that had been retrofitted into trade agreements with Peru and Columbia six years ago. Patent term extensions will not be mandatory nor will patent-registration linkage. Data/regulatory exclusivity will potentially have some clear public health safeguards. But each of these provision will loom on a fast-approaching horizon.
In exchange for these temporary concessions, the U.S. is proposing a ridiculously long period of biologic exclusivity - 12 years - far in excess of what other countries currently offer, if they offer biologic data exclusivity at all. Biologics are a growing element of total pharmaceutical expenditures and are particularly important with respect to certain chronic, non-communicable diseases such as diabetes and cancer that are of growing concern in low- and middle-income countries. The evidence justifying extended periods of biologic exclusivity is contested, even in the U.S., but the biotech industry has pushed its lobbying efforts at the USTR to historic levels to tie all TPP parties, even the U.S., to this unjustified period of monopoly control.
Don't be fooled. The U.S. is continuing to demand an IP straightjacket for all TPP members with respect to the IP terms that will become immediately effective to all parties. Moreover, the U.S. is fitting TPP middle-income countries for their future IP leg-irons. IP restraints will be a little looser in the short term, but highly constricting shortly thereafter. Monopolies on medicines will be longer, broader, and stronger. Generic competition and lower prices will be delayed. Patients will suffer and governments will face mounting costs for new medical technologies. The U.S.'s TPP transition period is fools gold.
by Health GAP Senior Policy Analyst, Brook Baker
In recent months, two countries with large economies and large populations both took steps to rework their patent laws, in part, to expand access to medicines. The moves come amid increasing concerns that treatments for certain ailments, such as AIDS and cancer, are out of reach for many people. Their actions also underscore growing tension with the pharmaceutical industry over pricing policies and an increasing willingness among some governments to rely on international trade agreements to consider compulsory licenses as a work-around solution. Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project, suggests other countries may be emboldened to do the same.
It is no coincidence that the governments of Brazil and South Africa have concurrently launched patent law reform projects designed to increase affordable access to medicines of assured quality. On October 9, the Brazilian Center for Strategic Studies and Debates formally launched its 363-page report “Brazil's Patent Reform: Innovation Towards National Competitiveness,” which included proposed legislation (read here). The report addresses patent law reform in Brazil taking into account the core standards of the WTO TRIPS Agreement, TRIPS flexibilities, public health imperatives, and industrial development.
And two months ago, the South African Department of Trade and Industries launched its long awaited Draft National Policy on Intellectual Property (here it is). Although the South African reform process is not as advanced as the Brazilian, the Draft Policy also proposes reforming South African patent law to take advantage of TRIPS flexibilities.
Brazil has historically played an important role in responding to the global AIDS pandemic and in shaping market dynamics affecting access to antiretroviral medicines. Brazil was the first developing country to offer universal free access to antiretroviral therapy for people living with HIV and AIDS in 1997. The country also used lawful flexibilities to manufacture pre-1995 antiretroviral domestically thereby reducing the costs of treatment by nearly 75 percent.
Relying on domestic production and sourcing key inputs from India helped to create economies-of-scale for active pharmaceutical ingredients, and those savings have in turn been utilized by Indian generic manufacturers, who have further reduced prices to a tiny fraction of their former cost. In addition, Brazil has used compulsory licenses and the threat of compulsory licenses to obtain lower prices on key ARVs and to accelerate technology transfer. In international forums, Brazil has consistently defended the rights of developing countries to adopt and safeguard TRIPS flexibilities.
Although South Africa lost a decade in its HIV response because of AIDS denialism, civil society was proactive in campaigning for cheaper AIDS medicines through intervention in drug company lawsuits, use of competition law, and promotion of voluntary licenses. More recently, the South Africa government has accelerated from ground zero in 2004 to providing public-sector treatment for over 2.2 million people living with HIV in 2012 and has achieved global best prices in its procurement of first-line antiretrovirals. Like Brazil, South Africa too has championed preservation of TRIPS flexibilities, particularly in African forums.
Now both countries have taken their global and regional stances further by proposing patent law reform that would make it much harder to gain and maintain IP monopolies on medicines. For example, following on the leadership in this area set by India, Brazil is now undertaking to erect stricter standards of patents to eliminate evergreening (lengthening of patent monopolies) via secondary patents on new uses and new forms of existing medicines.
To help improve the quality of its patent examination, Brazil proposes to adopt pre-grant opposition procedures with broad standing for both competitors and others to provide relevant information; it is reconfirming its drug regulatory authority’s beneficial role in reviewing pharmaceutical patents. The proposed patent law reform in Brazil also precludes patent term extensions for regulatory delays and provides for easier-to-use government-use licenses. Finally, the Brazilian reform confirms that Brazil will not allow monopolies on regulatory data to block registration of therapeutically equivalent generic medicines.
Similarly, the South African government has recently issued its own draft IP Policy that proposes many of the same reforms that are being pursued by Brazil. Like Brazil and India, South Africa proposes to restrict unwarranted patenting and re-patenting medicines by adopting higher standards with respect to patentable subject matter and inventive step. Even more importantly, South Africa is for the first time willing to consider operationalizing a patent examination system, at least on medicines, instead of relying on the blind-trust depository system it currently has that results in more patents on medicines than virtually any country in the world.
Like Brazil, South Africa will adopt opposition procedures to enhance the quality of its patent determinations and it is proposing to broaden its grounds for compulsory licenses and to ease procedures for their issuance. Under the permissive language of Article 39.3 of the TRIPS Agreement, South Africa is confirming its opposition to data/regulatory exclusivity that thwarts early registration/marketing approval for generic equivalents of previously registered medicines.
Going even further than Brazil in certain areas, South Africa proposes limiting IP-enforcement mechanisms to disallow border interference with lawful trade in generic medicines and to make proactive use of competition law to regulate IP-related voluntary licenses. In the same vein, South Africa will undertake to make its existing parallel importation regime more useable.
It is a positive signal to low- and middle-income countries more broadly that Brazil and South Africa join India and other countries like Uganda, Zambia, Botswana, and Malawi that are also taking proactive steps to incorporate lawful TRIPS compliant flexibilities, including stringent standards of patentability, pre- and post-grant opposition procedures, easier-to-use compulsory and government use licenses, and restrictions on data/regulatory monopolies among others. Hopefully the leadership of powerful middle-income countries on three continents will create a groundswell of IP reform in the Global South designed to enact and then use all available measures to ensure affordable access to medicines for all.
The pharmaceutical industry and its supporters in the offices of US and EU trade negotiator will not sit quietly while these reforms are undertaken. Both countries have already seen a counter-offensive mounted in the media and behind the scenes with government officials by pharmaceutical company lobbyists and spokespersons – academic or otherwise, who present the same tired litany of responses: less IP in developing countries will ruin the monopoly profits needed to incentive research in the next generation of life-saving medicines; patents aren’t the problem, the problem is weak health systems; and the absence of IP is thwarting innovative activity by domestic inventors, creators, and artists. Each of these responses has been discredited over and over again by unrebutted evidence, but that doesn’t prevent the pharmaceutical industry from seeking to preserve and expand its monopoly empires, especially in so-called pharmerging countries like India, South Africa, and Brazil.
Success in the proposed reforms is by no means certain. Threats of pharmaceutical Armageddon, trade losses, and domestic disinvestment will be made. Domestic political and economic elites might be more satisfied with obtaining sweetheart deals and private concessions than with prioritizing the public health needs of the broader population. Fortunately, the reform efforts in Brazil and South Africa have not come out of a social vacuum. Both countries have strong civil society and health activist campaigns that have fought for the requested reforms for many years.
The Treatment Action Campaign first addressed these needed reforms in the early 2000’s but then launched a much more concerted campaign along with Doctors Without Borders and Section 27 in 2011. Brazilian activists have similarly challenged their government to be more proactive and to adopt the mainstream reforms that have now been put forward.
The aspiration to achieve the right to health in Brazil and South Africa, and in low- and middle-income countries more broadly, cannot be achieved under the yoke of IP fundamentalism and the continuing threat of longer, stronger, and broader IP monopolies on medicine. Leading countries need to claw back their policy space – the policy space they fought for in the TRIPS and Doha Declaration negotiations. Instead of sticking their necks out sporadically and individually, it makes sense for them to collaborate in adopting and operationalizing TRIPS flexibilities.
Once they amend their laws, then they can approach the more daunting task of implementing the flexibilities so as to achieve robust generic competition in broad markets. This will undoubtedly require coordination in the review of patent applications and in the issuance of compulsory licenses on strategic medicines. At the end of the day, such strategic alignment could embolden BRICS and other countries to question to wisdom and morality of allowing IP monopolies on essential global public goods like medicines and encourage them to pursue broader investigation of proposals to design a better incentive and market system that promotes and rewards therapeutically important innovation and affordable access to the resulting medical technologies.
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.