Funding the fight to end the AIDS epidemic: instructions from a time of austerity

New Health GAP analysis published on emboldening the fight to win the end of AIDS--and combatting austerity
Asia Russell's chapter "Funding the fight to end the AIDS epidemic: instructions from a time of austerity" was published as a in the new 2014 issue of AIDS Today, released at an International HIV/AIDS Alliance event at the London School of Economics last week. 
 
Health GAP is proud to be part of the first edition of The Alliance's new biennial publication presenting the global state of the civil society response to AIDS. 
 
In Russell's chapter, she describes the untenable contradiction civil society is faced with: the possibility that communities can secure massive gains in saving lives and halting new HIV infections based on aggressive scale up of evidence based interventions and defense and promotion of human rights, while in reality budget cuts are leaving life saving programs running on empty. 
 
Confronting this political doublespeak and winning the resources to seize this promise requires emboldened and dauntless activism, according to Russell. Read Health GAP's prescription for action--and the roadmap for urgently needed progress--here


Wikileaks Reveals How Obama Parrots Big Pharma's Monopoly Demands in Transpacific Trade Negotiations – Access to New AIDS, TB, and Hepatitis C Medicines Threatened

PRESS RELEASE * 17 October 2014 * For Immediate Release

Health GAP (Global Access Project)

Contact: Paul Davis: +1 202 817 0129 * pdavis@healthgap.org

 

Wikileaks Reveals How Obama Parrots Big Pharma's Monopoly Demands in Transpacific Trade Negotiations – Access to New AIDS, TB, and Hepatitis C Medicines Threatened

 

Wikileaks has released a 77-page document revealing the negotiation positions of the twelve Pacific rim countries locked in negotiations for a Trans-Pacific Partnership (TPP) Agreement. The leaks reveal nothing but bad news for hundreds of millions of people living both in rich and poor countries whose access to affordable medicines will be threatened by the patent extremism that the White House seeks to export and impose on TPP trading partners.

 

"The US Trade Representative and the Obama Administration continue to push the industry’s agenda for draconian levels of intellectual property protections that lengthen, broaden, and strengthen patent monopolies on medicines," say Professor Brook K. Baker, senior policy analyst for Health GAP. "Proposed language makes it easier to get successive, secondary patents on minor changes or new uses of existing medicines, and patent term extensions that increase monopoly profits on vital medicines--but at the cost of reduced access for poor and uninsured patients."

 

In a surprising change from previously leaked TPP texts, the U.S. appears to be erecting new barriers against countries' use of compulsory and government use licenses that have been widely accepted as lawful for 125 years, and confirmed in the WTO’s 1995 TRIPS Agreement. In addition, the U.S. continues to push for data or regulatory monopolies that prevent marketing approval of more affordable generic products, thereby erecting a second, rigid barrier to access. For biologic drugs these data/regulatory monopolies could last as long as 12 years. In exchange for its unwavering insistence on patent maximization, the Obama Administration is offering only illusory, temporary transition periods to developing country TPP members--after which they too will be bound to the most pro-industry set of IP protections on medicines that has ever been proposed.

 

Activists noted that the TPP texts, prepared in secret by the Obama Administration and its industry advisors without review by patient groups or Congress, is another reason to reject White House requests on The Hill for Trade Promotion Authority or “Fast Track”. Fast Track will limit the constitutionally-mandated responsibility of Congress to regulate trade policies, and the President will be pushing for a ‘Fast-Track’ vote in the coming months. “This text illustrates the urgency with which Congress must reject President Obama’s request for ‘Fast Track’” said Health GAP’s Paul Davis. “Otherwise, the pharmaceutical industry giveaways in the TPP will make all of us sick.”

 

"Although the negative effect of the US's IP intransigence is most acute in poorer countries, the proposed TPP IP provisions will also tie hands of policy makers here, since several of the provisions will require changes in U.S. law," say Matt Kavanagh, also a senior policy analyst at Health GAP. “Even worse, the TPP’s investment chapter will give ‘Big Pharma’ the right to seek private arbitration against all TPP parties, including the U.S., whenever industry feels that their expectations of monopoly profits are adversely affected by changing patent and regulatory standards or by adverse judicial or administrative decisions.”

 

"The disclosed TPP text is a bonanza for Big Pharma, and a disaster for patients everywhere," said Asia Russell, recently appointed Executive Director of Health GAP. "In a world that continues to be threatened by unmet needs for access for medicines for conditions ranging from HIV/AIDS, hepatitis, and ebola to diabetes, heart disease and cancer, the Obama administration has administered a noxious potion of monopoly protections for Big Pharma and other IP transnationals."

 

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The Dangers of the Indian Government’s Flirtation with U.S. Pharma and the Risks for India’s Coherent, Pro-Public Health IP Policy

The Dangers of the Indian Government’s Flirtation with U.S. Pharma and the Risks for India’s Coherent, Pro-Public Health IP Policy

by Professor Brook K. Baker*

  Senior Policy Analyst Health GAP (Global Access Project) 

October 5, 2014

http://www.equilibri.net/nuovo/articolo/dangers-indian-governments-flirtation-us-pharma-and-risks-indias-coherent-pro-public-health

India’s new Prime Minister, Narendra Modi and his delegation, who have been visiting the U.S. for the first time, have spent considerable time and energy in courting U.S. business interests.  On Monday, September 29, the Indian PM met with 17 chief executives of major U.S. companies in joint and individual meetings1 and on September 30 he met with the U.S.-India Business Council comprising over 300 top U.S. companies.2  Prime Minister Modi is promising to open India to more direct foreign investment and to further liberalize the Indian economy to make it easier for multinational corporations to operate there. To the dismay of health activists worldwide, the US administration appears to have successfully used the Indian PM’s visit to maneuver the Indian government into committing to a joint mechanism on intellectual property. The benign sounding “High Level Intellectual Property (IP) Working Group” is designed to pressure India into changing its interpretation and application of health safeguards in India’s intellectual property policy, ultimately undermining India’s role as the pharmacy for the poor.

Even before the PM’s visit, alarm bells have been ringing within the global health community over statements made by India’s Minister of Commerce and Industry, Nirmala Sitharaman. The relentless public and private pressure from both the U.S. government and Big Pharma,3 appear to have prompted the Commerce Minister to announce a review of India’s IP policy with the aim of boosting innovation, improving administrative procedures, and potentially strengthening the country’s patent regime. In announcing the creation of a think tank to make the patent system “more robust,” Minister Sitharaman specifically mentioned that “developed nations are picking holes in India’s IPR laws.”4

The pressure from the US government on India has been relentless for the better part of the past year. The United States Trade Representative, which designated India as a priority watch list country on its 2014 Special 301 Watch List,5 Members of Congress, who have now demanded a second investigation of India’s alleged IP protectionism at the U.S. International Trade Commission,6 and various pharmaceutical industry representatives have continued a broadside attack on India’s IP rules, especially as they relate to bio-pharmaceuticals.7 When India amended its patent law to conform to international requirements in 2005, it adopted measures to restrict patents on unworthy, minor modifications or new uses of existing medicines and allowed competitors and advocates to challenge patents before and shortly after they are granted.  India also has adopted procedures, fully compliant with the WTO TRIPS Agreement, to allow compulsory licenses when patents are abused or when public health needs so require.

As a consequence of these pro-health measures, India has turned down some weak secondary patents on previously known medicines, but it has also issued thousands of patents for Big Pharma companies. Indeed, India should improve its administrative procedures not to become speedier and more lax in granting patents but rather to follow its recently promulgated standards reviewing pharmaceutical products,8  which should reduce its record of granting unworthy patents.9  The U.S. and the E.U. have complained about India’s strictness in not granting patents that they have granted to their own domestic pharmaceutical giants, but other voices on both continents are crying for tighter patent standards to reverse the flood of secondary patents that extend drug company monopolies and price medicines beyond all reasonable bounds.

Although at least two pro-Pharma news stories in the past few week have complained about India having issued compulsory licenses and building its industry on stolen patents,10 the truth of the matter is that India has issued only one compulsory license on a grossly overpriced Bayer cancer medicine, Nexavar®. As always, PhRMA’s pundits claim that the right to issue compulsory licenses is severely limited and only applies to emergencies, when in fact compulsory licenses can be granted on any declared public interest grounds at the full discretion of each government.

Unfortunately, the joint communiqué issued at the end of PM Modi’s US visit shows deference by the US and Indian governments to Big Pharma’s pressure.11  Buried in that statement is an ominous collaboration:

The leaders committed to work through the Trade Policy Forum to promote a business environment attractive for companies to invest and manufacture in India and in the United States.  Agreeing on the need to foster innovation in a manner that promotes economic growth and job creation, the leaders committed to establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the Trade Policy Forum. 

The U.S. consistently advances higher intellectual property protections through its trade working groups and trade partnership groups.  It is significant that this sentence is embedded in the section on economic growth, as US IP industries and the USTR promote heightened intellectual property rights and strengthened enforcement mechanisms as being key to investor confidence and ultimately to innovation itself.  Direct foreign investment and innovation are also always rhetorically tied to strong IPRs despite inclusive evidence that typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements.12

More specifically, this working group will give the US a dedicated forum to continue to pressure India to adopt TRIPS-plus IP measures, including repeal of section 3(d) of the India Patents Act, adoption of data exclusivity/monopolies, patent term extensions, and restrictions on the use of compulsory licenses.  There will also be efforts to strengthen enforcement measures and investor rights including investor/state dispute resolution.  The US, in particular, will work to eliminate local working requirements that India is seeking to use to promote its own technological development. This is antithetical to PM Modi’s recently launched “Make in India” initiative. The fact that this working group will have "decision-making" powers is particularly problematic as it places the US fox in the Indian chicken coop. 

Nothing stops the Indian government and Prime Minister Modi from rejecting the US proposal for the working group on IP. The Indian government must recognize that the US trade agenda is deadly to poor people throughout the developing world who depend on India’s generic companies for affordable access to medicines of assured quality.  Nearly 90% of the 13 million people currently receiving HIV medicines in low- and middle-income countries get their antiretrovirals from India.  While Big Pharma wants to charge a $1000 a pill for new hepatitis C medicines in the U.S.,13 Indian companies can make those same medicines for a little more than $1 a pill.14  One positive signal of IP resistance from PM Modi during the trip was his statement to pharmaceutical CEOs Kenneth Frazier and Michael Ball:   

I understand that you want to be compensated for your investments in R&D. At the same time, India needs medicines that are affordable for its population. … Mankind needs continuous research and development of new drugs for a higher quality of life. … You need to be able to devote the right energy to that, not just by changing the formulation of a drug to sustain a patent, but by inventing things that make a difference to mankind.15 

U.S. business interests and government officials are trying to sell the idea that heightened intellectual property protections in India are essential to foreign investment, innovation, and achievement of public health goals.16 Instead, heightened IPRs will make India consumers captive to Big Pharma’s extortionate pricing.  India’s vibrant generics industry will be relegated to the backwaters as it waits impatiently for the expiration of ever-greened patents and new regulatory data monopolies.  India is still in the stage of industrial development where imitation and incremental innovation are stronger engines of progress than being shackled by foreign IP monopolies.  When Indian firms do innovate, they can patent their true inventions in India and their incremental innovations in rich country markets. Just as dozens of distinguished scientists, academics, and health organizations protested the proposed IP policy review in India,17 health activists and others must reject any efforts to fill India’s alleged gaps in IP policy with pro-Pharma fixes that serve only to line the pockets of some of the world’s richest transnational corporations.

REFERENCES

1 Vikas Dhoot, PM’s US Visit:  Narendra Modi’s CEO diplomacy to soon set the cash register ringing, The Economic Times (Oct. 1, 2014), http://articles.economictimes.indiatimes.com/2014-10-01/news/54516935_1_ajay-banga-ceos-global-investment-radar

2 Arun Kumar, After wowing Indian-Americans and the ‘Big Apple’, PM Modi off to win over Barack Obama administration, The Economic Times (September 29, 2014) http://articles.economictimes.indiatimes.com/2014-09-29/news/54437114_1_prime-minister-narendra-modi-pm-modi-us-india-business-council.

3 USIBC concludes successful pharmaceutical mission to India, The Pharma Letter (Sept. 28, 2014), http://www.thepharmaletter.com/article/usibc-concludes-successful-pharmaceutical-mission-to-india.

4 Govt to come out with IPR policy:  Sitharaman, Business Standard (Sept. 8, 2014) http://www.business-standard.com/article/pti-stories/govt-to-come-out-with-ipr-policy-sitharaman-114090800852_1.html; Govt signals IPR recast ahead of Modi’s US visit, The Indian Express (Sept. 9, 2014) http://indianexpress.com/article/business/economy/govt-signals-ipr-recast-ahead-of-modis-us-visit/2/.

5 USTR, 2014 Special 301 Report, pp. 37-43, http://www.ustr.gov/sites/default/files/USTR%202014%20Special%20301%20Report%20to%20Congress%20FINAL.pdf.

6 Press Release, Ways & Means, Senate Finance Leaders Request ITC Investigation into India’s Unfair Trade Practices (Sept. 25, 2014) http://waysandmeans.house.gov/news/documentsingle.aspx?DocumentID=394536.

7 C.H. Unnikrishnan, India’s draft rules on patenting drugs draw mixed response, Live Mint (Sept. 29, 2014) http://www.livemint.com/Industry/J9t072PXGxIEzMmOBusSKJ/Indias-draft-rules-on-patenting-drugs-draw-mixed-response.html.

8 Office of Controller General of Patents, Designs and Trademarks, Revised Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (Aug. 12, 2014) http://www.ipindia.nic.in/iponew/draft_Pharma_Guidelines_12August2014.pdf.

9 Sudip Chaudhuri, Chan Park & K. M. Gopakumar, Five Years into the Product Patent Regime:  India’s Response (2010) http://apps.who.int/medicinedocs/documents/s17761en/s17761en.pdf; Bhaven N. Sampat & Tahir Amin, How Do Public Health Safeguards in Indian Patent Law Affect Pharmaceutical Patenting in Practice, 38:4 J. Health Politics, Policy & Law 735-55 (2013) http://jhppl.dukejournals.org/content/38/4/735.long.  

10 Tom Giovanetti, India’s Modi can boost foreign investment by protecting IP, The Hill (Sept. 25, 2014) http://thehill.com/blogs/congress-blog/foreign-policy/218810-indias-modi-can-boost-foreign-investment-by-protecting-ip; Rod Hunter, The PM must walk the talk on FDI, Hindustan Times (Sept. 19, 2014) http://www.hindustantimes.com/StoryPage/Print/1265781.aspx.

11 White House, U.S.-India Joint Statement (Sept. 30, 2014) http://www.whitehouse.gov/the-press-office/2014/09/30/us-india-joint-statement.

12 Brook K. Baker, Debunking IP-for-Development:  Africa Needs IP Space Not IP Shackles in International Economic Law and African Development (Laurence Boulle, Emmanuel Laryea & Franziska Sucker eds. 2014).

13 John Tozzi, Gilead Sales Double on $1,000 Hepatis C Pills, Bloomberg Business Week (April 22, 2014), http://www.businessweek.com/articles/2014-04-22/gilead-sales-double-on-1-000-hepatitis-c-pills.

14 Andrew Hill et al., Minimum costs for producing Hepatitis C Direct Acting Antivirals for use in large-scale treatment access programs in developing countries, 58:7 Clin. Infect. Dis. 928-36 (2014) http://cid.oxfordjournals.org/content/58/7/928.full.pdf+html.     

15 Vikas Dhoot, PM’s US Visit:  Narendra Modi’s CEO diplomacy to soon set the cash register ringing, The Economic Times (Oct. 1, 2014), http://articles.economictimes.indiatimes.com/2014-10-01/news/54516935_1_ajay-banga-ceos-global-investment-radar.

16 Joe Matthew, ‘India Needs To Show It Values Innovation’:  PhRMA, a US drug companies’ lobby, looks to Modi’s US visit to iron out access issues, Business World (Oct. 1, 2014) http://www.businessworld.in/news/opinion/interviews/‘india-needs-to-show-it-values-innovation’/1555371/page-1.html#.

17 Rupali Samuel, Academics, diplomats, scientists, lawyers, public health orgs issue open letter to PM on proposed IP Policy review, Spicy IP (Sept. 23, 2014), http://spicyip.com/2014/09/academics-diplomats-scientists-lawyers-public-health-orgs-issue-open-letter-to-pm-on-proposed-ip-law-review.html; CSOs concerned over timing of IP policy review in India, SUNS #7881 (Sept. 25, 2014) http://www.twnside.org.sg/title2/wto.info/2014/ti140911.htm.

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*Brook K. Baker is a law professor at Northeastern University School of Law (US) and an affiliate of its Program on Human Rights and the Global Economy. He is also an honorary research fellow at the University of KwaZulu Natal, Faculty of Law, South Africa. He is a policy analyst for Health GAP (Global Access Project) and writes frequently on IP, trade, and access to medicines issues. 

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AIDS & Health Activists Blast American Pharma Companies and Politicians for Attempts to Undermine India

 

Press Statement

For Immediate Release: September 30, 2014

Contact: Matthew Kavanagh, +1 202-486-2488, matthew@healthgap.org

 

AIDS & Health Activists Blast American Pharma Companies and Politicians for Attempts to Undermine India, the “Pharmacy of the Developing World,” Call on  Indian Prime Minister Narendra Modi to Stand Strong Against US Pressure to Change its Pro-Public Health Patent Laws

 

While India supplies the world with affordable medicines, pharmaceutical industry manipulation of weak U.S. patent law keeps American drug prices high. India must not make the same mistake.

 

(Washington, D.C.) AIDS and health activists today harshly criticized attempts by major U.S. pharmaceutical companies and American politicians to pressure and manipulate Indian Prime Minister Narendra Modi, who today meets with members of the US-India Business Council in Washington, D.C. Activists warned that following American-led policy proscriptions could severely damage the Indian economy and health system, as well as restricting access to affordable medicines for patients around the world. They called on Prime Minister Modi to stand strong against persistent and unwarranted US pressure to change the country’s pro-public health patent laws.

 

Indian generic drug manufacturers currently provide India, and much of the world, with high-quality affordable medicines: 90% of HIV patients in low- and middle-income countries rely on Indian generics for their treatment, and 40% of American generic drugs are made by Indian producers. “Indian generics have been essential to expanding access to medicine around the world,” said Asia Russell, Health GAP’s Director of International Policy. “I am based in Uganda, where  expanded access to Indian generics has had a transformative impact on the HIV epidemic. Around the world, we’ll rely on Indian generics again for treatment of diseases such as hepatitis C, given that Indian firms can make generic versions of new treatments 1,000 times cheaper than what multinational pharmaceutical companies charge in first world markets.”

 

Threatened by free trade of high-quality and affordable medicines, US-based pharmaceutical companies and politicians friendly with the industry are using prominently placed op-eds, large advertisements on Washington, D.C. buses, and letters to President Obama to spread false information—claiming India’s rules are not legal or discourage innovation. The companies have been threatening to withhold investment if India does not adopt weaker patent laws that would extend pharmaceutical monopolies and stymie the country’s generic industry. The bullying has been far-reaching. In anticipation of the prime minister's visit, Senator Robert Menendez (R-NJ) said, "we need to see real reforms on [intellectual property], which significantly impacts the ability of US companies to do business in an important market." The US Trade Representative listed India on its “priority watch list” in this year’s Special 301 Watch List, which is annually published to shame countries with intellectual property legislation that is not to American businesses and politicians’ liking. As a result, India may face US trade sanctions. Members of Congress have also demanded an investigation into what they call India's "IP protectionism." This is despite India’s intellectual property laws being fully in line with international standards, as outlined in World Trade Organization agreements.

 

“India fully complies with international law while also making it possible for billions of people in India and around the world to access life-saving affordable drugs,” said Matthew Kavanagh, Health GAP’s Senior Policy Analyst. “Giving U.S. pharmaceutical companies longer monopolies would help their bottom line—but at the cost of the Indian economy and the lives of millions of people.”

 

India’s pharmaceutical industry has been able to flourish because of the country’s pro-public health patent laws, in which patents are only granted on new medicines or for significant changes on old medicines. The U.S., in contrast, regularly gives out patents on slightly tweaked versions of old medicines that do not provide enhanced therapeutic benefit, extending monopoly protection and keeping prices high.

 

“Whereas the U.S. regularly gives patents on frivolous and small changes to old medicines, keeping prices high, India has decided to prioritize public health over pharmaceutical profits,” said Brook Baker, law professor at Northeastern University and Health GAP analyst. “U.S. companies are threatening not to invest in India, saying only stronger intellectual property will drive foreign direct investment and more innovation. But studies show this simply is not true—middle income countries with extremely high IP rules see no benefit in investment or research, but they do see far higher medical costs that undermine their public health systems.

 

“Rather than shaming India, the US should learn from the country’s use of intellectual property policy to promote true innovation and equitable access to medicine,” Baker said.

 

Already Modi’s administration has shown signs that it may bend to pressure from US businesses and politicians, who threaten to restrict foreign investment in India’s booming economy if intellectual property laws don’t change. The country's Minister of Commerce and Industry, Nirmala Sitharaman, has initiated a review of India’s IP policy, saying that she wanted the patent system to become "more robust.”

 

“Health activists around the world are in solidarity with Prime Minister Modi,” Kavanagh said. “We’re calling on the Indian government not to bend to U.S. pressure. Patients around the world are relying on it.”

 

 

 

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Health GAP Welcomes New Global HIV Treatment Goals

Contact: Matthew Kavanagh 
Health GAP Welcomes New Global HIV Treatment Goals: 
Governments Must Address Generics, Close the Funding Gap, & Deliver On Human Rights to Move from Words to Action to End the AIDS Crisis

 
For Immediate Release   

September 25, 2014


 
New York, NY—Health GAP (Global Access Project) today welcomed the roll out of new strategic HIV goals for treatment of HIV, announced on the sidelines of the UN General Assembly session by Presidents of South Africa, Mali, Ghana, and Switzerland, U.S. Secretary of State John Kerry, and UN officials. The new goals set a target of getting as many countries as possible to achieve “90/90/90 by 2020”—90% of people living with HIV know their status, 90% of those are accessing HIV treatment, and 90% of those on treatment have achieved an undetectable viral load.

“These new targets focus  for the first time on coverage plus quality—ensuring people have access to quality programs and can achieve an ‘undetectable’ viral load, which is critical to save lives, halt disease progression, and prevent new infections,” said Asia Rusell, Director of International Policy. “Governments must make this a priority—which requires a radical redesign of programs, getting the opportunity for treatment to all people in need with low-cost generic medicines and through human rights based programs that get medicines much loser to communities.”

We applaud Secretary Kerry for supporing these targets—we must end AIDS; we must achieve 90/90/90. But funding is falling far far short and we have to ask: where’s the funding to meet these targets? U.S. Bilateral HIV programs has been cut by over $600 million in the last few years,” said Amanda Lugg, Chairperson of Health GAP. "We have the science, implementation capacity, and the vision to achieve universal access to testing, treatment, and quality care, but we need commitment and money as well. Small investments in expanding PEPFAR and Global Fund spending now - less than a billion new dollars a year will save millions of lives and tens of billions of dollars in the future.  The House of Representatives this year included an extra $300 million for the PEPFAR program—we call on Sec. Kerry to do everything we can to increase funding this year.”
 

“The practice of turning people away from HIV treatment because they’re not yet sick enough—their CD4 count hasn’t fallen enough—is NOT an evidence-based practice,” continued Russell. “Its time that every person, regardless of CD4 count, had a chance to understand the benefits and risks and to start HIV treatment if that is what they choose. With funded human rights structures in place to ensure this choice is meaningful and freely made, achieving 90/90/90 should make its way into every country’s national plan, Global Fund concept note, and PEPFAR plan."


“Meanwhile, we must also address the critical question of the price of new medicines--deadly attempts to roll back intellectual property flexibilities that allow generic drug production in India and other middle-income countries could make a joke out of 90/90/90. We call on the Obama administration and all governments to commit to supporting public health over drug company profits,” said Lugg.

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