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Thailand, Drug Patents, Compulsory Licensing: HIV, HCV, Heart Disease
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A series of articles published this year discussing controversies and issues in this recently exploding development in drug development.
Thailand put on USA's list of wrongdoers over patents
02/05/2007
www.pharmatimes.com
The USA has added Thailand to its 'priority watch list,'a ranking of serial violators of intellectual property, and has also expressed its concerns about regulatory barriers and price controls for drugs in some European countries.
The United States Trade Representative (USTR) has issued its annual 'Special 301'report on "the adequacy and effectiveness of intellectual property rights" protection by the country's trading partners. The centrepiece of the report is the priority watch list of the worst offenders and the only new addition this year is Thailand. The other 11 are Argentina, China, Chile, Egypt, India, Israel, Lebanon, Russia, Turkey, Ukraine and Venezuela.
The USTR's decision has much to do with piracy of CDs and DVDs,as well as counterfeited consumer and industrial goods, but specifically noted that "trade in counterfeit pharmaceuticals is a particularly grave concern". With this in mind, it is not surprising that Thailand makes the list, given its recent decision to issue compulsory licenses for Abbott Laboratories'AIDS drug Kaletra (opinavir/ritonavir) and Plavix (clopidogrel), the anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb, allowing the use of patented material to produce cheaper local versions. However, this reason was not given by the USTR.
The move brought criticism from a number of groups, notably Knowledge Ecology International, whose executive director James Love, noted that "the sanctioning of countries for using legitimate and important flexibilities...brings shame to all US citizens who are increasingly seen in Thailand and elsewhere as bullies and hypocrites." He claimed that "what the Bush administration has done is to sanction Thailand for doing what it is supposed to do: 'promote access to medicines for all'," and concluded by saying that "we should not be giving the impression to the world that US pharmaceutical industry lobbyists can use USTR to settle commercial disputes, entirely outside of the framework of global trade rules."
US worried about price controls elsewhere
The USTR report also noted that even where a country's intellectual property rights regime is adequate, "price controls and regulatory and other market access barriers can discourage the development of new drugs." To address these issues, the USTR and the Departments of Health and Human Services, Commerce and State formed a task force and has begun dialogue with some countries whose ideas on prices and regulatory affairs may not tally with those of the USA.
This has taken the form of pursuing free trade agreements with Australia and most recently South Korea which include commitments to improve access to innovative products "and to ensure the transparent, predictable, and non-discriminatory pricing and reimbursement of innovative and generic pharmaceutical products, medical devices and biologics."
The USA has also "established a constructive dialogue with Germany on policy goals and concerns related to health care," said the USTR, after it raised specific concerns related to Germany's reference pricing system for determining product reimbursement "and the transparency of the government's decision-making process regarding pharmaceutical pricing."
The Americans are also less than pleased about moves in Poland "which appear to reduce the official maximum wholesale and retail prices for imported drugs by 13% while generally leaving unchanged the prices for drugs of Polish origin." Talks with the Poles, as well as with Italy and France are planned in the coming year, in a bid to promote "expanded dialogues."
Opinion divided as Abbott stops selling new drugs in Thailand
16/03/2007
Abbott Laboratories'announcement that it will not market any new drugs in Thailand following the government's decision to issue a compulsory license for the company's HIV drug Kaletra has received the backing of a leading figure in the pharmaceutical industry but fierce condemnation from pressure groups.
Abbott was stunned when the country's health minister, Mongkol na Songkhla confirmed at the end of January that the government had issued compulsory licenses to buy generic versions of Abbott's drug, Kaletra (lopinavir/ritonavir), as well as Plavix (clopidogrel), the blockbuster anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb. Given the arbitrary nature of the Thai move and its disregard for patents, Abbott has decided to withdraw marketing applications for six drugs in the country.
The US firm received the backing of Arthur Higgins, chairman of Bayer HealthCare, who told journalists after the German company's financial press conference in Leverkusen that "I fully support Abbott" and the stance the firm and the industry taking. He added that the government's move is not in "the long-term interest of the Thai people" and "is a very dangerous development."
However Abbott's decision has not gone down well in Thailand and the Bangkok Post quotes Permanent Secretary for Justice, Jarun Pukditanakul, as saying that "the drug industry is an obvious profit-oriented business but its present business protection goes beyond the limit to the extent that the principle of human rights has been completely forgotten." He added that the government is responsible for HIV-positive people and those suffering from chronic heart disease, therefore it was legally and morally right to balance business profits and the good health of the public by announcing compulsory licensing.
Abbott is also facing the ire of the humanitarian organisation Medecins Sans Frontieres (Doctors Without Borders). MSF says that Thailand desperately needs the new, heat-stable version of Kaletra and in the USA, Abbott no longer sells the old version of the treatment, which requires refrigeration, but will continue to market it in Thailand, "where tropical temperatures make it highly impractical to use." David Wilson, of MSF in Thailand, said that "refusing to sell the drug here is a major betrayal to patients."
Pharma firms call on Thailand to talk, not issue licences
30/01/2007
The world's innovative drugmakers have responded quickly to the news that Thailand is to issue compulsory licences to buy generic versions of Abbott Laboratories'AIDS drug Kaletra and Plavix, the blockbuster anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb as the country cannot afforded the still patent-protected treatments.
Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, said that "when a country is grappling with severely-limited resources," the long-term interest of patients "will be best served by the government initiating direct discussions with the companies that invent, develop and market innovative medicines to directly address key health challenges."
Dr Bale went on to say that often, originator companies "can actually offer resource-constrained" countries "equal or even better conditions than generic producers, in terms of both price and service, and I urge the Thai Government to discuss this directly with innovative companies."
It seems this argument will cut very little ice with the Thai authorities and health minister Mongkol na Songkla was reported in The Bangkok Post as saying that he is not worried that pharmaceutical firms may freeze investment in Thailand in protest at his decision to import copycat versions of Kaletra (lopinavir/ritonavir) and Plavix (clopidogrel). "Most of these costly drugs are produced somewhere else, not in Thailand. Nobody knows if they produce these drugs cheaply in other countries and just import into Thailand for expensive and profitable sales," he said.
Novartis launches legal action over India's patent laws
Meantime, Swiss drug giant Novartis'legal action in India following the decision by the country's patent office to decline coverage for its cancer drug Glivec/Gleevec ((imatinib) has begun in Chennai. As well as that particular ruling, the company is also contesting the constitutional validity of much of India's patents law as a whole.
The Indian Patent Office said Novartis'Glivec application did not satisfy its requirements for "novelty and inventive step" and the company says that the country's law, introduced a new "improved efficacy" hurdle for patentability for new forms of known compounds, which Glivec falls foul of, as India deems it to be a new form of an existing treatment that was developed before the cut-off date.
"That Glivec failed the Indian test for patentability indicates the problems in India's patent system," says the Swiss firm, adding that "our case in India is solely about safeguarding intellectual property. This is not about patient access. In India, 99% of patients who receive Glivec receive it free from Novartis."
However this view is not universally shared and Unni Karunakara, medical director of Medecins Sans Frontieres'Campaign for Access to Essential Medicines said "Novartis is trying to shut down the pharmacy of the developing world." He added that "Indian drugs account for at least a quarter of all medicines we buy, and form the backbone of our AIDS programmes, in which 80,000 people in over 30 countries receive treatment. We cannot stand by and let Novartis turn off the tap." A petition asking the drug major to drop the case has almost 250,000 signatures on it, MSF claims.
Outcry as Thailand allows generic version of protected drugs
29/01/2007
In a move that is sure to cause consternation among pharmaceutical firms, the government of Thailand says that it is going to widen its strategy of issuing compulsory licenses to buy generic versions of cardiovascular and AIDS drugs that are still patent-protected.
The country's health minister, Mongkol na Songkhla, confirmed that "the laws have been signed and they are now effective," saying that the measure was necessary "because we have so many patients to treat with so little budget. We can't watch our people die."
Thailand is planning to buy generic versions of two drugs from companies in China or India, which will cost around 10% of the original price and Dr Mongkol has confirmed that they are Abbott Laboratories'AIDS drug, Kaletra (lopinavir/ritonavir), and Plavix (clopidogrel), the blockbuster anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb.
The Thai health ministry claims that the move is perfectly legal because under World Trade Organisation rules, a government is allowed to declare a national emergency and produce a patented drug without the permission of the patent owner. However, this line has not impressed the drugmakers.
Teera Chakajnorodom, president of Thailand's Pharmaceutical Research and Manufacturers Association, was reported in The Bangkok Post as saying "we fully appreciate the health challenges and financial constraints that the ministry faces. However, the best response to this situation is to engage constructively with industry to find a mutually agreeable solution.''Drugmakers had not been consulted and the decision had left the industry "stunned" and he added that "the law allows such actions with pharmaceutical products only in cases of extreme national emergencies, or during wartime, and only after negotiation with the companies concerned."
The news comes just a few weeks after the Thai government issued its first compulsory licence, to make a generic version of Merck & Co's antiretroviral Sustiva (efavirenz).
Sanofi-Aventis chief slams generics makers'"exploitation"
04/01/2007
Jean-Francois Dehecq, chairman of French-based drugs major Sanofi-aventis, has condemned generic drugmakers for manufacturing low-cost drugs in developing countries and then exporting them to rich nations, rather than making the generics available cheaply to poor people in their own countries.
It was a "scandal," Mr Dehecq told the Financial Times, that firms in countries such as India, Indonesia and Thailand were paying their workers "three times nothing" in wages to produce the drugs and then exporting them to countries where people are able to pay for them. He accused the firms of exploiting their own people, adding: "They should deal with their own countries first."
Mr Dehecq also defended research-based drugmakers against accusations that they charge too much for their products. These prices are essential to maintain innovation, he said, and claimed that industry estimates putting the cost of developing a new drug at around $1 billion were too low.
UK researchers offer "ethical pharmaceuticals"
Mr Dehecq's comments coincided with news that two UK-based academic researchers have developed a way of bringing new drugs to market much more cheaply than is currently the case, enabling inexpensive treatments to be made available not only to patients in the Third World but also, potentially, in the world's richest countries.
Sunil Shaunak, professor of infectious diseases at Imperial College, and Steve Brocchini of the London School of Pharmacy have produced a modified version of Roche's hepatitis C treatment pegylated interferon, which they have reformulated to make it suitable for use in hot climates. Development work on the modified product has been supported by The Wellcome Trust and several UK government departments, and Imperial College holds its patent. The Indian government is to subsidise the product's clinical trials and, if these prove successful, it will be manufactured by Indian drugmaker Shantha Biotechnics, which is based in Hyderabad. Drug trialling and manufacturing are significantly cheaper in India than in western countries and, if the drug succeeds in getting a license there, the Indian trial data could also be used to seek marketing approval for it in Europe.
Profs Shaunak and Brocchini are now working, in partnership with the Drugs for Neglected Diseases initiative, on a new version of US drugmaker Gilead Science's AmBisome (amphotericin B) as a treatment for leishmaniasis suitable for use in hot and poor countries.
The issue for branded drugmakers is whether these "ethical pharmaceuticals" are, in fact, new drugs that do not infringe their patents on the originator products. If they do not, then cut-price versions could soon be used to treat millions of patients in both the world's rich and poor nations.By Lynne Taylor
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