Oxfam and Health Action International issued a report in late October 2009 which alleged that the European Union was contradicting world trade rules by pandering to the interests of Big Pharma ahead of the needs of people in less developed countries to gain access to essential medicines. The report, Trading Away Access to Medicines: How the European Union's trade agenda has taken a wrong turn, argues that the EU has become guilty of double standards. It notes that the EU Member States and the European Commission have taken steps to improve access to health services in developing countries, and has acted to reduce the price of medicines within the borders of the EU, but argues that the EU now has a trade agenda which acts directly against these same objectives in developing countries. The report claims that the EU is pushing for a range of intellectual property measures that would support the commercial interests of the pharmaceutical industry whilst damaging the opportunities for innovation and access to medicines in developing countries. The report goes so far as to say that the EU's demands exceed those pursued by the Bush administration in the United States, whose intellectual property policies were criticised for their detrimental effect on developing countries.
In the report, the two organisations urge that the EU adopt a number of positions, including honouring commitments under the Millennium Development Goals, the Doha Declaration on TRIPS and World Health Assembly resolutions on innovation and access to medicines; and ensuring that its trade policy is in line with its development objectives, particularly with regard to access to healthcare and medicines. With regard to intellectual property, the EU should not misuse free trade agreements in order to implement TRIPS-plus rules which place conditions beyond the scope of the TRIPS agreement and its application to medicines in order to extend monopoly protection and limit access to medicines. The EC should stop exerting pressure on governments that attempt to introduce safeguards to protect and promote public health; and should amend its counterfeiting regulation to ensure that it does not have a detrimental impact on developing countries. The EU should also ensure that the Anti-Counterfeiting Trade Agreement (ACTA) does not set a new global standard for intellectual property rules that will impede access to medicines for developing countries; and should identify and support measures to improve access to generic medicines in developing countries, including the UNITAID patent pool for HIV / AIDS drugs.
The report also urges the EU that with respect to research and development, European donors should scale up financial contributions to R&D to address diseases that disproportionately affect people living in developing countries. The EU should also support Product Development Partnerships designed to deliver affordable and effective new products, and should continue building R&D capacity in developing countries. It should also support the implementation of the WHO's Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, and support the Expert Working Group in its efforts to find new models of innovation. Finally, the EC should take measures to ensure that specific initiatives meet real health needs, and that the EU's regulations on children's medicines can also be to the benefit of developing countries.
As can be seen, the report has a long list of recommendations, and many of them are not new for Oxfam. In the past, however, many of these allegations, such as those regarding TRIPS-plus free trade agreements, have been labelled at the US, and it is interesting that this has now changed. Whether the EU will be any more willing to adopt these recommendations than the US is unlikely. However, there is no doubt that groups such as Oxfam will not stop pushing for change.
Ian Platts, Editor, World Generic Markets
Tuesday, November 24, 2009
Tuesday, November 10, 2009
Of patent pools and regime change
The growing impetus to amend Canada's Access to Medicines Regime (CAMR) has gathered pace, with Canadian Senate committee hearings into Bill S-232, which aims to streamline the regime, now underway. The hearings' opening statements have thrown up an interesting question over whether or not the existing act has actually failed. Critics – of which there are many – of CAMR in its current guise argue that the regime has clearly failed, pointing to the fact that in the five years in which the act has been in law, only one company has been able to use it. That company was Apotex, which used the act to provide a very limited run of antiretrovirals to Rwanda, in two shipments in September 2008 and September 2009. In total, around 14 million doses of a fixed-dose combination product were shipped. However, Apotex has been very vocal about the difficulties the regime produced, and has added that it would not use the process again in its current form, throwing its weight behind efforts to amend CAMR, with the added carrot that it would use an amended regime to produce paediatric antiretrovirals. However, on the other side of the fence, supporters of the current regime point out that it has been used successfully, even if only once. Furthermore, in doing so, this is the only such access to medicines legislation in the world that has worked. The Senate committee asked the question what reasons are behind the regime being so little used. The difficulties in using the regime are certainly one possible answer, and another possibility is that Canadian manufacturers simply cannot compete on price with, for example, Indian or Chinese manufacturers. A further possibility raised in the hearings' opening was that other factors have played a part, particularly the Global Fund to Fight HIV/AIDS, which has provided funds of some US$16 billion. The issue that Canada will need to decide is should CAMR be amended, and if it is, will this make a difference globally?
Another possible route for increasing access to essential medicines is that of developing a patent pool, an idea which also saw a boost recently, with the UK's government indicating support for this measure. The basic aim of a patent pool is that all the patents for essential medicines are made available collectively, enabling generic firms to use them to produce drugs for developing countries, paying the patent owners royalty rates in return. UNITAID has decided in principle to establish a voluntary patent pool for medicines in a decision made in July 2008, but it is a scheme that appears to have gained little traction since. However, in a speech on 12th October 2009, the UK Minister for International Development, Mike Foster, said that the UK government supported UNITAID's efforts, according to Knowledge Ecology International. Mr Foster's comments came a few weeks after Médecins Sans Frontières launched an email campaign targeting nine brand name companies, which between them hold patents for 21 antiretrovirals.
Both of these initiatives are efforts to crack the same problem. However, it is worth bearing in mind that these are not the only options. The branded companies themselves have also made efforts to provide essential medicines to developing countries, providing drugs at cost, or even donating them. Cynics may argue that this is little more than window-dressing, maintaining good public relations, and indeed may well be right, but it does surely reflect an expectation, seen in all these efforts, that developing countries need to be given every option to access essential medicines in order to save the lives of millions.
Ian Platts – Editor, World Generic Markets
Another possible route for increasing access to essential medicines is that of developing a patent pool, an idea which also saw a boost recently, with the UK's government indicating support for this measure. The basic aim of a patent pool is that all the patents for essential medicines are made available collectively, enabling generic firms to use them to produce drugs for developing countries, paying the patent owners royalty rates in return. UNITAID has decided in principle to establish a voluntary patent pool for medicines in a decision made in July 2008, but it is a scheme that appears to have gained little traction since. However, in a speech on 12th October 2009, the UK Minister for International Development, Mike Foster, said that the UK government supported UNITAID's efforts, according to Knowledge Ecology International. Mr Foster's comments came a few weeks after Médecins Sans Frontières launched an email campaign targeting nine brand name companies, which between them hold patents for 21 antiretrovirals.
Both of these initiatives are efforts to crack the same problem. However, it is worth bearing in mind that these are not the only options. The branded companies themselves have also made efforts to provide essential medicines to developing countries, providing drugs at cost, or even donating them. Cynics may argue that this is little more than window-dressing, maintaining good public relations, and indeed may well be right, but it does surely reflect an expectation, seen in all these efforts, that developing countries need to be given every option to access essential medicines in order to save the lives of millions.
Ian Platts – Editor, World Generic Markets
Monday, October 26, 2009
PEPFAR reaches 100th approval
The US Department of Health and Human Services has marked the recent approval of the 100th antiretroviral drug to be approved through the PEPFAR programme. Ironically, by the time the FDA marked the event, the 101st product had already received approval. PEPFAR, the President's Emergency Plan for AIDS Relief, was introduced by President Bush in 2003 and has a remit to work in partnership with host nations through to fiscal year 2013 to support treatment for at least three million people, prevention of 12 million new infections and care for 12 million people, including five million orphans and vulnerable children. The programme allows the FDA to review antiretroviral drug applications on an expedited basis, with the aim of fast-tracking the approval of drugs in order for them to be used in developing countries, rather than the US. Most applications are generic, and most approvals are tentative, as they are for drugs which are still protected by patents in the US, and thus the generics cannot be marketed in the US.
A look at the drugs approved produces an interesting picture. The first to be approved was Barr Laboratories' didanosine capsules, which gained tentative approval on 3rd December 2004. This proved not only to be Barr's first and last drug approved under the PEPFAR programme, but also stands out as the only drug to enter the programme from an American company. In total, 13 companies have provided the 101 drugs, and of those 13, ten are Indian firms. Asides from Barr, the other two firms which are not based in India are Aspen Pharmacare, based in South Africa, and Huahai US, based in China. One of the Indian firms listed, Matrix Laboratories, is now majority-owned by the US' Mylan, but was an entirely Indian firm at the time many of its products were submitted and approved. Matrix also took the honours for both the 100th and 101st drugs to be approved under the programme. The dominance of Indian firms in the lists underscores the role India has carved out in producing generic antiretrovirals, and included in the list are some of the country's largest generic pharmaceutical manufacturers, including Ranbaxy Laboratories and Cipla, as well as smaller companies, such as Aurobindo Pharma, Emcure Pharmaceuticals and Hetero Drugs. Aurobindo has emerged as the company with the most drugs approved under PEPFAR, with 31 of the 101.
Quite why so few US generic firms have had antiretrovirals approved under the PEPFAR programme is curious. A quick look at the FDA's information for approved or tentatively approved antiretrovirals shows that, as with the PEPFAR programme, generic versions of these drugs are dominated by Indian firms, with only Barr and Roxane Laboratories standing out. The most likely reason is undoubtedly money. US firms will need to spend money to develop generic antiretrovirals, especially as many companies do not have any experience with antiretrovirals, and as most of these are still protected by patents in the US and thus cannot be marketed there, there will be no immediate prospect of returns. Of course, the patents will eventually expire, but at that point, home grown firms will have already lost the chance of marketing exclusivity to the multitude of Indian firms which have tentative approvals already; financial returns will therefore be minimal. However, neither the domestic nor international markets for antiretrovirals are getting any smaller, and whilst such drugs may not see the stellar returns promised by blockbusters such as fluoxetine has in the past, they may well provide a small but steady income, particularly in the US and other developed nations.
Ian Platts - Editor, World Generic Markets
A look at the drugs approved produces an interesting picture. The first to be approved was Barr Laboratories' didanosine capsules, which gained tentative approval on 3rd December 2004. This proved not only to be Barr's first and last drug approved under the PEPFAR programme, but also stands out as the only drug to enter the programme from an American company. In total, 13 companies have provided the 101 drugs, and of those 13, ten are Indian firms. Asides from Barr, the other two firms which are not based in India are Aspen Pharmacare, based in South Africa, and Huahai US, based in China. One of the Indian firms listed, Matrix Laboratories, is now majority-owned by the US' Mylan, but was an entirely Indian firm at the time many of its products were submitted and approved. Matrix also took the honours for both the 100th and 101st drugs to be approved under the programme. The dominance of Indian firms in the lists underscores the role India has carved out in producing generic antiretrovirals, and included in the list are some of the country's largest generic pharmaceutical manufacturers, including Ranbaxy Laboratories and Cipla, as well as smaller companies, such as Aurobindo Pharma, Emcure Pharmaceuticals and Hetero Drugs. Aurobindo has emerged as the company with the most drugs approved under PEPFAR, with 31 of the 101.
Quite why so few US generic firms have had antiretrovirals approved under the PEPFAR programme is curious. A quick look at the FDA's information for approved or tentatively approved antiretrovirals shows that, as with the PEPFAR programme, generic versions of these drugs are dominated by Indian firms, with only Barr and Roxane Laboratories standing out. The most likely reason is undoubtedly money. US firms will need to spend money to develop generic antiretrovirals, especially as many companies do not have any experience with antiretrovirals, and as most of these are still protected by patents in the US and thus cannot be marketed there, there will be no immediate prospect of returns. Of course, the patents will eventually expire, but at that point, home grown firms will have already lost the chance of marketing exclusivity to the multitude of Indian firms which have tentative approvals already; financial returns will therefore be minimal. However, neither the domestic nor international markets for antiretrovirals are getting any smaller, and whilst such drugs may not see the stellar returns promised by blockbusters such as fluoxetine has in the past, they may well provide a small but steady income, particularly in the US and other developed nations.
Ian Platts - Editor, World Generic Markets
Friday, October 9, 2009
Goldshield bidding war
A bidding war broke out in September 2009 over Goldshield Group, the UK-based pharmaceutical and consumer health company. The battle is being fought out by two investment vehicles, AIT Investments and Midas Bidco.
Goldshield began life in 1991, gained its first marketing authorisation for a product it had developed itself in 1996, and floated on the London Stock Exchange in 1998. The Group was founded by two brothers, Ajit and Kirti Patel, along with a third partner, Shane Gogerly. In recent years, Goldshield was one of a number of companies to face investigations over alleged price fixing by both the Serious Fraud Office and the NHS. Although the cases ultimately collapsed, the investigations did see both Ajit Patel and Kirti Patel step down from the firm's Board in order to fight allegations levelled at them; Kirti Patel now occupies the position of Group Executive Director in the company. Perhaps ironically, given the legal battles the firm has faced, Goldshield's current Non Executive Chairman is Dr Keith Hellawell, who in previous years was a Chief Constable for two British police forces and in the late 90s was responsible for the UK's anti-drugs policy. For its most recent fiscal year, ended March 2009, Goldshield reported revenues worth £98.4 million (US$156.9 million), with profit after tax of £13.9 million (US$22.1 million). This was a significant improvement on the revenues of £84.9 million and profit after tax of £6.3 million reported for the previous fiscal year.
Ajit Patel is now involved in one of the parties bidding to acquire Goldshield, AIT Investments, which was the first to announce an offer. AIT describes itself as a newly-incorporated company formed by the Fuhrer family for the purpose of implementing the acquisition of Goldshield. The Fuhrers are an Israeli family which own and control the Neopharm group of companies, which market ethical pharmaceuticals and branded consumer healthcare products.
The other bidder for Goldshield is Midas Bidco, an investment vehicle set up by Goldshield's management team; involved in this bid is Goldshield co-founder, Kirti Patel; the two brothers are thus facing off over control of the company they set up and then had to withdraw from in order to fight the price fixing allegations.
AIT commenced bidding for Goldshield with an offer of 440 pence per share, valuing the company at some £162.1 million (US$257.1 million). In response, Midas announced it had put financial backing in place to allow it to make an offer above 440 pence per share. AIT hit back, raising its offer to 450 pence per share, valuing the company at £165.7 million (US$262.8 million). Bidco then upped its offer to 460 pence per share, making the firm worth £169 million (US$268.0 million). In the latest turn, AIT then increased its bid on 2nd October to 480 pence per share, which would value Goldshield at £176.8 million (US$280.4 million). At the time of writing, this is where the bidding rests. However, there is no doubt that the deal, which has pitched two brothers against each other, is not yet done.
Ian Platts - Editor, World Generic Markets
Goldshield began life in 1991, gained its first marketing authorisation for a product it had developed itself in 1996, and floated on the London Stock Exchange in 1998. The Group was founded by two brothers, Ajit and Kirti Patel, along with a third partner, Shane Gogerly. In recent years, Goldshield was one of a number of companies to face investigations over alleged price fixing by both the Serious Fraud Office and the NHS. Although the cases ultimately collapsed, the investigations did see both Ajit Patel and Kirti Patel step down from the firm's Board in order to fight allegations levelled at them; Kirti Patel now occupies the position of Group Executive Director in the company. Perhaps ironically, given the legal battles the firm has faced, Goldshield's current Non Executive Chairman is Dr Keith Hellawell, who in previous years was a Chief Constable for two British police forces and in the late 90s was responsible for the UK's anti-drugs policy. For its most recent fiscal year, ended March 2009, Goldshield reported revenues worth £98.4 million (US$156.9 million), with profit after tax of £13.9 million (US$22.1 million). This was a significant improvement on the revenues of £84.9 million and profit after tax of £6.3 million reported for the previous fiscal year.
Ajit Patel is now involved in one of the parties bidding to acquire Goldshield, AIT Investments, which was the first to announce an offer. AIT describes itself as a newly-incorporated company formed by the Fuhrer family for the purpose of implementing the acquisition of Goldshield. The Fuhrers are an Israeli family which own and control the Neopharm group of companies, which market ethical pharmaceuticals and branded consumer healthcare products.
The other bidder for Goldshield is Midas Bidco, an investment vehicle set up by Goldshield's management team; involved in this bid is Goldshield co-founder, Kirti Patel; the two brothers are thus facing off over control of the company they set up and then had to withdraw from in order to fight the price fixing allegations.
AIT commenced bidding for Goldshield with an offer of 440 pence per share, valuing the company at some £162.1 million (US$257.1 million). In response, Midas announced it had put financial backing in place to allow it to make an offer above 440 pence per share. AIT hit back, raising its offer to 450 pence per share, valuing the company at £165.7 million (US$262.8 million). Bidco then upped its offer to 460 pence per share, making the firm worth £169 million (US$268.0 million). In the latest turn, AIT then increased its bid on 2nd October to 480 pence per share, which would value Goldshield at £176.8 million (US$280.4 million). At the time of writing, this is where the bidding rests. However, there is no doubt that the deal, which has pitched two brothers against each other, is not yet done.
Ian Platts - Editor, World Generic Markets
Friday, September 25, 2009
Grindeks looks to expand
The Latvian firm, Grindeks has made a few announcements recently which reveal the firm is aiming to expand its business. On 19th August, the firm reported that it was considering establishing injections manufacturing in Latvia, and was looking at the territory of Riga Free Port as a possible site to construct a new plant, because of economic incentives and tax allowances offered there. However, the firm added that purchasing an existing plant would also be an option. This was followed on 7th September with an announcement that the firm was considering options to develop its ointment business. Here, Grindeks is looking at two possibilities: either move its existing operations in Tallinn, Estonia, to Latvia, or remain in Tallinn, and presumably develop the plant there. As yet, no decision has been made.
Grindeks has, in recent years, been undertaking an investment programme, and these recent announcements are in line with that. In January 2009, the firm opened a new final dosage forms plant; the firm commented that this had been the largest investment project in the company's history, with LVL9.1 million (US$16.8 million) invested over two years. It is anticipated that the new plant will increase manufacturing productivity and capacity substantially, to 1.5 billion tablets and 500 million capsules per year.
Additionally, in August this year, Grindeks also announced that it had introduced a new active pharmaceutical ingredient, ursodeoxycholic acid, used in the treatment of hepatic and gallstone diseases. The new API represents a new medical therapeutic group for the firm, and has been developed as part of a co-operation agreement with the German firm, Marenis Pharma; once again evidence of Grindeks' plans to expand. The firm also announced it had started construction on a new manufacturing unit with an investment of nearly LVL6 million (US$12.5 million), connected with the development of this API. This again is an important move for the company; Germany is a relatively unexplored territory for Grindeks, whose traditional markets have been those of Central and Eastern Europe, the Baltic States and the CIS. Although Grindeks has co-operated with Merck in Germany, its presence there has been limited. The development of new APIs is of course also significant. Despite the economic turmoil of recent months, Grindeks appears to still be on course to expand its horizons.
Ian Platts – Editor, World Generic Markets
Grindeks has, in recent years, been undertaking an investment programme, and these recent announcements are in line with that. In January 2009, the firm opened a new final dosage forms plant; the firm commented that this had been the largest investment project in the company's history, with LVL9.1 million (US$16.8 million) invested over two years. It is anticipated that the new plant will increase manufacturing productivity and capacity substantially, to 1.5 billion tablets and 500 million capsules per year.
Additionally, in August this year, Grindeks also announced that it had introduced a new active pharmaceutical ingredient, ursodeoxycholic acid, used in the treatment of hepatic and gallstone diseases. The new API represents a new medical therapeutic group for the firm, and has been developed as part of a co-operation agreement with the German firm, Marenis Pharma; once again evidence of Grindeks' plans to expand. The firm also announced it had started construction on a new manufacturing unit with an investment of nearly LVL6 million (US$12.5 million), connected with the development of this API. This again is an important move for the company; Germany is a relatively unexplored territory for Grindeks, whose traditional markets have been those of Central and Eastern Europe, the Baltic States and the CIS. Although Grindeks has co-operated with Merck in Germany, its presence there has been limited. The development of new APIs is of course also significant. Despite the economic turmoil of recent months, Grindeks appears to still be on course to expand its horizons.
Ian Platts – Editor, World Generic Markets
Tuesday, September 8, 2009
Canadian manufacturers squabble over statistics
Canada’s Patented Medicine Prices Review Board (PMPRB) has issued its Annual Report for 2008, leading to claims and counter-claims by the country’s generic and branded industry organisations. The Canadian Generic Pharmaceutical Association (CGPA) used the report to criticise the branded industry, noting that for the eighth year in a row, the branded industry had failed to reach its threshold of 10% of their Canadian revenues being ploughed into Domestic R&D spending; this having been a commitment made by the branded industry in 1987, with the adoption of amendments to the Patent Act. In response, Canada’s Research-Based Pharmaceutical Companies (Rx&D) has sought to play down the last eight years of failing to reach the target, arguing instead that its member companies’ total investments in R&D in Canada over the last 20 years has averaged more than 10% of sales. Of course, both sides are correct in their assertions, depending on how the data is analysed. It is worth noting also that the PMPRB’s report states that Rx&D members accounted for 89.4% of all reported R&D expenditures in 2008, with patentees reporting a total of C$1.3 billion (US$1.2 billion) of R&D expenditures.
However, whilst the overall average for the last 20 years is for over 10% of sales put into domestic R&D, the figures presented by the PMPRB’s report show that the branded industry only met and / or exceeded the 10% figure in eight years, between 1993 and 2000, whilst Rx&D member companies managed to meet and / or exceed the figure in ten years, between 1993 and 2002. Despite the occasional blip, the ratio figure has been falling since those years, having reached 8.1% for all patentees in 2008, and 8.9% for Rx&D members.
Rx&D brought attention to wider issues, noting that the PMPRB’s report also showed that whilst the Consumer Price Index climbed by 2.3% in Canada in 2008, prices for patented medicines rose by only 0.1% during the same period. The organisation added that over the past decade, prices for innovative medicines were around 7% below the international median. However, against that, the report also shows that Canadian prices were the third highest of seven comparator countries, behind only the US and Germany. However, the US was highest by some margin, skewing the figures somewhat.
The PMPRB’s report gives a detailed look at the state of the Canadian branded industry’s finances, but as always, its findings are open to interpretation of the statistics. The claims and counterclaims of both the branded and generic industries hold up when viewed in the right context, despite apparently being at odds with each other. Perhaps then, the value of the report is that it shows that both sides could do better.
Ian Platts - Editor, World Generic Markets
However, whilst the overall average for the last 20 years is for over 10% of sales put into domestic R&D, the figures presented by the PMPRB’s report show that the branded industry only met and / or exceeded the 10% figure in eight years, between 1993 and 2000, whilst Rx&D member companies managed to meet and / or exceed the figure in ten years, between 1993 and 2002. Despite the occasional blip, the ratio figure has been falling since those years, having reached 8.1% for all patentees in 2008, and 8.9% for Rx&D members.
Rx&D brought attention to wider issues, noting that the PMPRB’s report also showed that whilst the Consumer Price Index climbed by 2.3% in Canada in 2008, prices for patented medicines rose by only 0.1% during the same period. The organisation added that over the past decade, prices for innovative medicines were around 7% below the international median. However, against that, the report also shows that Canadian prices were the third highest of seven comparator countries, behind only the US and Germany. However, the US was highest by some margin, skewing the figures somewhat.
The PMPRB’s report gives a detailed look at the state of the Canadian branded industry’s finances, but as always, its findings are open to interpretation of the statistics. The claims and counterclaims of both the branded and generic industries hold up when viewed in the right context, despite apparently being at odds with each other. Perhaps then, the value of the report is that it shows that both sides could do better.
Ian Platts - Editor, World Generic Markets
Friday, August 21, 2009
Oxfam's fears over ACTA and generics
In a press release issued just before the fifth round of negotiations for the Anti-Counterfeiting Trade Agreement (ACTA) got under way in Morocco, Oxfam warned of its fears that the final agreement could lead to generic firms being subject to criminal prosecutions for sending generics to countries in need (see p. 4). However, the likelihood of such an outcome from ACTA is open to question. Of course, on the face of it, ACTA is not concerned with generic drug markets, or indeed the provision of legitimate drugs, whether branded or generic, to developing countries. According to the Office of the US Trade Representative, its roots lie in a desire to tackle the proliferation of counterfeit and pirated goods around the world. It sprung from preliminary talks in 2006 and 2007, with negotiations beginning in June 2008 involving Australia, Canada, the EU and its 27 member states, Japan, Mexico, Morocco, New Zealand, South Korea, Singapore, Switzerland and the US. The round of discussions in Morocco was the fifth round, with the next round to be held in Korea in November 2009. Negotiations are expected to be completed in 2010.
With regard to Oxfam’s fears, the organisation comments that the secrecy surrounding the talks raises fears that the interests of poorer nations will be ignored, and cites the EU’s recent seizures of generic medicines as evidence. Oxfam argues that the EU is taking the lead in pushing for a deal that would require all participating countries to increase seizures and prosecute companies which produce generics legally for sale in other countries. The organisation claims that this will include countries not directly involved in the negotiations, and notes that only two of the countries involved in negotiations are developing countries. Oxfam argues that this could encourage Big Pharma to file frivolous patents to maintain their monopolies.
The official line on the secrecy surrounding the talks is that this is an accepted practice during trade negotiations which allows views to be exchanged in confidence in order to arrive at a final consensus. The argument that multinational pharmaceutical companies would use the agreements to file ‘frivolous’ patents to prevent generics is questionable. Such a blatant attempt would be a public relations disaster, akin to the backlash seen with the South African patent laws debacle in 2001. It would also fly in the face of patent legislation seen in countries such as Canada, the EU and the US, which has sought to tackle such issues of evergreening. To be successful, ACTA will need to fit in with the existing TRIPS framework; the WTO has consistently been at pains to insist that TRIPS would not get in the way of sending generics to countries in need. However, it is fair to note, as Oxfam does, that EU member states have recently been seizing shipments of generics passing within its borders and headed to developing nations, often under suspicions of patent or trademark infringement, although the shipments have ultimately been allowed to continue their journeys. In addition, US free trade agreements passed in recent years have often been accused of being ‘TRIPS-plus’ in making extra demands regarding intellectual property rights that are not necessarily in line with TRIPS requirements. However, it seems unlikely that preventing shipments of generics would either be the intent or the outcome of the negotiations.
With regard to Oxfam’s fears, the organisation comments that the secrecy surrounding the talks raises fears that the interests of poorer nations will be ignored, and cites the EU’s recent seizures of generic medicines as evidence. Oxfam argues that the EU is taking the lead in pushing for a deal that would require all participating countries to increase seizures and prosecute companies which produce generics legally for sale in other countries. The organisation claims that this will include countries not directly involved in the negotiations, and notes that only two of the countries involved in negotiations are developing countries. Oxfam argues that this could encourage Big Pharma to file frivolous patents to maintain their monopolies.
The official line on the secrecy surrounding the talks is that this is an accepted practice during trade negotiations which allows views to be exchanged in confidence in order to arrive at a final consensus. The argument that multinational pharmaceutical companies would use the agreements to file ‘frivolous’ patents to prevent generics is questionable. Such a blatant attempt would be a public relations disaster, akin to the backlash seen with the South African patent laws debacle in 2001. It would also fly in the face of patent legislation seen in countries such as Canada, the EU and the US, which has sought to tackle such issues of evergreening. To be successful, ACTA will need to fit in with the existing TRIPS framework; the WTO has consistently been at pains to insist that TRIPS would not get in the way of sending generics to countries in need. However, it is fair to note, as Oxfam does, that EU member states have recently been seizing shipments of generics passing within its borders and headed to developing nations, often under suspicions of patent or trademark infringement, although the shipments have ultimately been allowed to continue their journeys. In addition, US free trade agreements passed in recent years have often been accused of being ‘TRIPS-plus’ in making extra demands regarding intellectual property rights that are not necessarily in line with TRIPS requirements. However, it seems unlikely that preventing shipments of generics would either be the intent or the outcome of the negotiations.
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