5-14-2013 It all seemed to be going so well for the big pharmaceutical companies (big pharma). National governments used to be able to choose whether to grant patents on pharmaceutical products or not. Some countries such as India didn't award any patents at all, literally giving generics drugs companies free licence to copy lifesaving drugs at affordable prices. Then the World Trade Organization's (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into force, effectively handing Big Pharma exclusive patents in all markets as of 2005.
The heady days of the blockbuster drugs are, if not over, then in hiatus. Pharmaceutical companies have long complained of ever-rising R&D costs while being unable to replace the big sellers as they reach the end of their 20-year patents, known as the "patent cliff" – some of the biggest, such as heart medicines Lipitor and Plavix made a combined $14.5bn – yes, billion – in the US market in 2011 alone, yet their patents expired in 2012. https://www.theguardian.com/sustainable-business/patent-wars-india-takes-on-big-pharma
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9-26-2019 PhRMA, a lobbying group that represents American pharmaceutical industry, takes issue with the Patents Act of India, due to its narrow patentability standards, which put a firm limit on the patentability of pharmaceutical innovations that do not display therapeutic efficacy. This is in contrast to the endless add-on patenting in the United States, which allows pharmaceutical companies to extend exclusivity and therefore pricing power for their medications….
There are three key provisions in the intellectual property rights chapter of the renegotiated NAFTA that would also be incorporated into any free-trade pact with India, all of which would prove to be a major coup for American pharmaceutical profiteering….Locking developing countries into regressive patent laws to protect the profits of the pharmaceutical industry is a time-honored tradition in American trade policy…
Of course Trump campaigned as a trenchant opponent to the status quo of American trade deals, hammering NAFTA and indicting the TPP in his indictment of the Obama-Clinton axis. But in an exceedingly predictable turn of events Trump is now championing exactly those sorts of arrangements….“The trade deal is a short-cut to take away India’s public health safeguards….said Leena Menghaney, head of Doctors Without Borders’ Access Campaign in South Asia. “A trade deal with the U.S. will not only be disastrous for India but also for all other developing and least-developed countries where Indian generics are exported.”
Of course if Trump was serious about lowering drug prices, he could do so much more expeditiously by working on patent reform. That issue hasn’t been raised since a 2011 push by the Obama administration to rein in some of the more egregious patent practices that have been uniquely responsible for escalating prices in the United States. The bill was downed in Congress and hasn’t been touched since. The arrangement recalls the Janus-faced nature of the Trump experience in miniature: an empty pledge to curtail the most extreme corporate abuses while actively facilitating untold corporate giveaways behind the scenes. https://prospect.org/world/trump-modi-big-pharma-india-trade/
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4-13-20 the failure of the U.S.-India trade deal For decades Indian pharmaceutical companies such as Cipla and Sun Pharmaceuticals have specialized in reverse-engineering pharmaceuticals and mass-producing cheap alternatives for their residents and the world. Government-imposed price caps make these drugs affordable for not only Indians but also globally. Forty percent of America’s prescription drugs come from India, and even China — which supplies the world with much of the raw materials for drug production, including India for the active ingredients in HCQ — smuggles Indian drugs. India’s generic medicine has been instrumental in the fight against HIV and malaria and has especially benefited the developing world.
Yet the Western pharmaceutical industry has long viewed these successes as a threat and, for years, has fought legal and diplomatic battles to compromise Indian generics. Until the World Trade Organization strong-armed India in 2005, India had barred patents on medical products altogether.
“It's a trend,” said Malini Aisola about the latest interaction between Trump and Modi. She works for the affordable healthcare advocacy All India Drug Action Network. “Trump and the U.S., in general, have never known how to play fair. It's always been a relationship of bullying. Price controls are the sovereign right of any country,” said Aisola. “They should never have been on the table, not as part of a trade deal. It would be absolutely absurd if India tried to negotiate with the U.S., [demanding that they] not impose price controls on any drugs.”
“America needs India because America, one of the richest countries in the world, has been foolish enough to have a bad health industry,” said Chinu Srinivasan, a health advocate and drug manufacturer. “Some people glorify the patent process regime and call it ‘intellectual property,’ but there’s nothing intellectual about it and it’s not property.”
The highest-grossing pharmaceutical companies, such as Johnson & Johnson, Bayer, and Novartis, are Western, except for Astellas Pharma and Takeda Pharmaceutical, which are Japanese. U.S.-headquartered Johnson & Johnson is the most valuable pharma company in the world, with a $368 billion market cap and grossing $82.6 billion in 2019, while the largest Indian pharmaceutical company, Sun Pharmaceuticals, grossed $4.2 billion.
“Western countries didn't have a patent system until they became powerful in terms of pharmaceuticals,” said Srinivasan. “Once they got there then they start talking of patents and intellectual property rights. Developing countries have an enormous challenge. The patent system doesn't work in the interest of ordinary people.”
“[P]harmaceutical and software companies muscled their way into the WTO and turned it into a royalty-collection agency simply because the WTO can apply trade sanctions,” argued Bhagwati in his book In Defense of Globalization. “The move gave multilateral legitimacy to the use of trade sanctions to replace unilateral means of collecting royalties from developing countries.”
Big Pharma’s commitment to protecting intellectual property over saving lives was exposed during the AIDS epidemic, when Nelson Mandela passed a law in South Africa to allow the import of low-cost medicine. “The new law sparked a furious reaction from Big Pharma,” wrote Katherine Eban in her book Bottle of Lies. “Fearing a domino effect, 39 international brand-name drug companies, with the support of the U.S. government, sued South Africa, claiming that the new health law violated [TRIPS].”
Western prices for the “AIDS cocktail” were $10,000 to $15,000 a year, and the then-George H. W. Bush-led administration backed its pharma companies. When Dr. Yusuf Hamied, an Indian pharmaceutical tycoon, revealed that he could provide the same treatment for only $350 a year, there was a huge backlash. It took years of activism and a PR debacle for Big Pharma to back down, ultimately allowing India to export and save millions of people--not just in Africa but also in the U.S. https://webcache.googleusercontent.com/search?q=cache:j3RcvqPRXf0J:https://www.thejuggernaut.com/coronavirus-worlds-pharmacy%3Fs%3Dck903zzk100uh0711fi57c6b0+&cd=4&hl=en&ct=clnk&gl=us&client=safari
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“This is one of the first times we’ve actually seen pharma lose,” said Rep. Earl Blumenauer, an Oregon Democrat who leads a subcommittee on trade. “They have a remarkable track record because they are a huge political force. They spend lots of money on lobbying, on advertising, on campaign contributions. But we held firm, and we won on all counts.”
“The announcement made today puts politics over patients,” the leading drug industry trade group, PhRMA, said in a statement last week. …
Drug makers (after 2006) began raising prices of existing drugs several times a year, sometimes totaling more than 20% annually. They also started launching biologics with list prices topping six figures a year. In May, U.S. regulators approved a one-time gene therapy, Zolgensma, with an eye-popping price of $2.1 million per patient….
Facing public anger, Democratic resistance and the fact that Canada and Mexico had no reason to support the protections for biologics, the Trump administration yielded. https://www.spokesman.com/stories/2019/dec/19/north-america-trade-pact-deals-rare-setback-to-big/
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7-19-20
Poonawalla said in a POLITICO interview: “If you don't allow, for example, an Indian producer to sell in the U.S. because of some stupid rules and regulations, even though the product is identical to a U.S. product, you're going to have a supply situation. And guess what,” he continued. “When you've got low supply and high demand, what happens to the price? It skyrockets.”…
But Poonawalla also wants to pressure companies and governments to start changing the landscape, using the moral example of Covid-19 — and the global need for inexpensive vaccines on a massive scale — to illustrate the flaws in the current system, which he believes hamper the availability of life-saving protections in the developing world and access to low-cost drugs in wealthier countries. https://www.politico.com/news/magazine/2020/07/19/coronavirus-vaccine-price-big-pharma-368114
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