In late April, the Ontario government’s Ministry of Health and Long-Term Care announced it was taking legal action against seven generic firms, along with a number of pharmacies and wholesalers, for allegedly massaging professional allowances by re-selling drugs. Professional allowances are monies that generic drug manufacturers pay pharmacies for buying their prescription drug products, and the Ontario government has alleged that a number of firms were involved in a scheme whereby pharmacies bought greater stocks than they needed, claiming the monies against the stock, then returning what was not needed to wholesalers, which then also claimed monies for the returned stock. The seven companies involved included Taro Pharmaceuticals, Cobalt Pharmaceuticals, Genpharm, Teva’s subsidiary, Novopharm, Pharmascience, Sandoz Canada and ratiopharm. In total, the seven received Rebate Penalty Orders worth C$3.5 million (US$3.0 million), with Taro penalised the least, at C$22,512.68, and Genpharm and Novopharm the most, at C$1,791,957.71 and C$1,202,958.88, respectively.
The Ontario government explained that the professional allowances system had been shaken up as part of changes made by Bill 102 to the legislation that governs Ontario’s publicly funded drug programmes. For the Ontario Drug Benefit market, manufacturers could provide and pharmacies receive up to 20% of generic drug product sales per pharmacy in professional allowances. The allowances must then be used for activities outlined in the regulations, such as patient care that benefits customers. There was no limit on the amount of professional allowances relating to the private market. Drug manufacturers are required to report to the Ministry of Health and Long-Term Care the amount of professional allowances paid, and pharmacies the amount received. Pharmacies are also required to report on how the allowances are spent. Any professional allowance payment not meeting the regulated requirements would be regarded as a rebate, and prohibited. The Ministry reviewed these reports and found discrepancies between the figures being given by generic firms and those being given by pharmacies, and this led to a series of audits being carried out at 14 locations, including three generic drug firms, five wholesalers and six pharmacies.
According to local reports, manufacturers claimed to have paid C$332 million (US$284 million) in rebates, whilst pharmacies claimed to have received only C$145 million (US$124 million). In view of this, the decision to fine the seven generic firms just C$3.5 million in total and all parties involved C$33.8 million (US$28.9 million) surely does not serve as much of a disincentive.
Ian Platts - Editor, World Generic Markets
Showing posts with label generic. Show all posts
Showing posts with label generic. Show all posts
Thursday, May 14, 2009
Thursday, March 26, 2009
Despite speculation, Actavis branches out
Despite the ongoing speculation over the firm’s future, Actavis was busy in March branching out into new geographies. On 9th March 2009, the firm announced that it had entered the Irish market, with plans that will see the creation of up to 25 new jobs, and on 12th March, the firm and Japan’s ASKA Pharmaceutical signed a legal agreement to establish a joint company in Japan. Despite the headline, Actavis’ arrival in Ireland is not entirely new; a unit was set up there in 2008, and currently employs 11 people. However, Actavis’ presence in Ireland was relatively limited, and the new push will boost Actavis’ operations in the country. The firm aims to quickly ramp up its offering in Ireland in all channels, including hospital-specific, prescription and OTC drugs, and Actavis has stated that it has set double-digit growth targets for its first post-announcement year in the country, with an aim to rapidly expand its sales and marketing team in the coming months. Actavis is keen to play up its economic plus-points, noting in its announcement that its generics offer a reduction of up to 60% on the cost of drugs, ramming home the point by adding that there is a potential to save over 22 million euros (US$28.4 million) on six of the 20 new products it plans to launch in Ireland this year. Adding to the argument, Actavis was able to announce on the same day that it was launching gemcitabine in Ireland, along with other parts of Europe, on the day of patent expiry. This, the firm claims, could create savings in Ireland of 1.8 million euros (US$2.3 million), if all currently gemcitabine sales were switched to Actavis’ generic. However, whether such potential savings could be achieved is debateable; Ireland has low generic drug usage rates, and a government that has not shown much interest in changing this.
The move into Japan is entirely new for Actavis, however, and will see the firm set up business in a country it has had no previous business interests in. The agreement between Actavis and ASKA was first announced in November 2008, when the two firms concluded a preliminary agreement to establish a joint venture, to be called Actavis ASKA. Actavis will be the minority partner in the venture, holding 45% of its stocks, with ASKA holding the 55% stake. Japan has tended to be a somewhat difficult market for generic firms; it is second only to the United States in terms of healthcare spending, but the nation as a whole has always favoured the use of branded pharmaceuticals, with the result that generics have only managed to gain a toehold in the country. However, the situation has potential to change through the Japanese government, which, keen to reduce healthcare costs, introduced a generic substitution measure in April 2008, as part of an ongoing effort to increase generic market share in terms of volume. Although Actavis and ASKA have remained tight-lipped over what products will be marketed, the aim of the joint venture is for ASKA to enter the generics market using Actavis’ portfolio.
Ian Platts - Editor, World Generic Markets
The move into Japan is entirely new for Actavis, however, and will see the firm set up business in a country it has had no previous business interests in. The agreement between Actavis and ASKA was first announced in November 2008, when the two firms concluded a preliminary agreement to establish a joint venture, to be called Actavis ASKA. Actavis will be the minority partner in the venture, holding 45% of its stocks, with ASKA holding the 55% stake. Japan has tended to be a somewhat difficult market for generic firms; it is second only to the United States in terms of healthcare spending, but the nation as a whole has always favoured the use of branded pharmaceuticals, with the result that generics have only managed to gain a toehold in the country. However, the situation has potential to change through the Japanese government, which, keen to reduce healthcare costs, introduced a generic substitution measure in April 2008, as part of an ongoing effort to increase generic market share in terms of volume. Although Actavis and ASKA have remained tight-lipped over what products will be marketed, the aim of the joint venture is for ASKA to enter the generics market using Actavis’ portfolio.
Ian Platts - Editor, World Generic Markets
Friday, March 13, 2009
Biosimilars in the US a step closer?
President Obama has released his budget proposals, including those for the Department of Health and Human Services. The proposal would provide US$76.8 billion to the HHS, whilst the FDA is requesting nearly US$2.4 billion, an increase of 5.7% over the budget that the agency received for the current fiscal year. Not surprisingly, much of the focus on the healthcare aspects of the budget have been on the headline-grabbing issues, such as healthcare reform and the doubling of funding for cancer research. However, another aspect of the budget which deserves attention is its proposal to establish a regulatory pathway to approve generic biologics.
This has long been a thorny issue for the United States with the result that the country has lagged behind the European Union, where a basic approval pathway for biosimilars has been hammered out. Progress on the issue in the US has never been forthcoming, with the opposing sides of the argument clashing on all issues surrounding biosimilars, from their safety and efficacy to the length of data exclusivity periods for biologic products. Whilst none of the parties may have actually said that they do not want biosimilars allowed, the efforts to torpedo any attempt to create a pathway have spoken volumes.
With the new budget proposal specifically seeking to create a regulatory pathway, the question of whether this logjam can be broken has to be asked. President Obama has a focus on healthcare issues in general, with an intention to make the system more cost-effective and widen coverage for more Americans. Mr Obama’s nomination, albeit a second attempt after Tom Daschle, of Kathleen Sebelius, currently the Governor of Kansas, to the post of Secretary of Health and Human Services can be seen to underscore a determination to make changes. Ms Sebelius is a popular Democratic governor in a Republican-dominated state, a position which suggests that bipartisan working has been an essential element of Ms Sebelius’ job, and in turn suggests the same approach will be used should she become the head of the HHS. Thus the job would be taken by somebody with experience in successfully negotiating between staunchly opposed interests, which would surely be essential in any effort to produce a working regulatory pathway for biosimilars. Prior to this nomination, Henry Waxman was voted by the Democratic Caucus to become Chairman of the Committee on Energy and Commerce, which will have oversight on healthcare issues. Mr Waxman has long been known to support establishing a regulatory pathway for biosimilars, and his appointment must surely up the ante.
However, this is an issue which has long confounded its advocates, and whilst the political landscape may have moved to more fertile grounds for creating a pathway, the arguments against it have not been diminished. The issue of biosimilar safety will continue to be a problem, particularly for a litigious nation; entrenched arguments over data exclusivity will not now go away, and the savings through generic biologics will still be pitted against costs to American innovative companies and their employees. The push to create a pathway may have taken one step forward, but there still remains plenty of opportunity for its opponents to claw two steps back.
Ian Platts - Editor, World Generic Markets
This has long been a thorny issue for the United States with the result that the country has lagged behind the European Union, where a basic approval pathway for biosimilars has been hammered out. Progress on the issue in the US has never been forthcoming, with the opposing sides of the argument clashing on all issues surrounding biosimilars, from their safety and efficacy to the length of data exclusivity periods for biologic products. Whilst none of the parties may have actually said that they do not want biosimilars allowed, the efforts to torpedo any attempt to create a pathway have spoken volumes.
With the new budget proposal specifically seeking to create a regulatory pathway, the question of whether this logjam can be broken has to be asked. President Obama has a focus on healthcare issues in general, with an intention to make the system more cost-effective and widen coverage for more Americans. Mr Obama’s nomination, albeit a second attempt after Tom Daschle, of Kathleen Sebelius, currently the Governor of Kansas, to the post of Secretary of Health and Human Services can be seen to underscore a determination to make changes. Ms Sebelius is a popular Democratic governor in a Republican-dominated state, a position which suggests that bipartisan working has been an essential element of Ms Sebelius’ job, and in turn suggests the same approach will be used should she become the head of the HHS. Thus the job would be taken by somebody with experience in successfully negotiating between staunchly opposed interests, which would surely be essential in any effort to produce a working regulatory pathway for biosimilars. Prior to this nomination, Henry Waxman was voted by the Democratic Caucus to become Chairman of the Committee on Energy and Commerce, which will have oversight on healthcare issues. Mr Waxman has long been known to support establishing a regulatory pathway for biosimilars, and his appointment must surely up the ante.
However, this is an issue which has long confounded its advocates, and whilst the political landscape may have moved to more fertile grounds for creating a pathway, the arguments against it have not been diminished. The issue of biosimilar safety will continue to be a problem, particularly for a litigious nation; entrenched arguments over data exclusivity will not now go away, and the savings through generic biologics will still be pitted against costs to American innovative companies and their employees. The push to create a pathway may have taken one step forward, but there still remains plenty of opportunity for its opponents to claw two steps back.
Ian Platts - Editor, World Generic Markets
Wednesday, February 18, 2009
FTC files testosterone gel complaint
On 2nd February 2009, the Federal Trade Commission announced that it had filed a complaint against brand firm Solvay Pharmaceuticals and generic firms Watson Pharmaceuticals, Par Pharmaceutical Companies and Par’s partner, Paddock Laboratories regarding Solvay’s AndroGel testosterone gel product. The FTC has alleged that the companies violated section 5(a) of the FTC Act, arguing that Solvay entered into agreements with the firms which led to Solvay paying them in return for their not launching generic versions of AndroGel. The FTC’s actions see it return to a familiar and frustrating battle in which it argues that such payment arrangements are anti-competitive, whilst the companies involved argue the exact opposite.
The FTC’s position has for a long time been that agreements in which a branded company essentially pays a generic competitor not to launch a competing product hampers competition and is thus illegal. As an example, in 2001, the FTC brought a lawsuit against Schering-Plough, Upsher-Smith Laboratories and American Home Products alleging such payments regarding Schering’s potassium chloride product, K-Dur 20. Despite settling with AHP, the FTC found little success in the case, with an FTC Administrative Law Judge finding the agreement had been lawful. This led to the FTC overturning the decision, despite it having been made by an FTC judge. However, in 2005, a federal appellate court again found in favour of the companies, and the decision has so far stuck. This, along with another similar decision in 2005 has led to a raft of payment agreements in the years since, which the FTC still contends harms competition by prolonging monopolies.
Given its entrenched view on the matter, it is no surprise that the FTC has again made a complaint. However, the current argument concerning AndroGel does not appear to shed any new light on the issue, and as a result, it seems unlikely that the FTC will succeed this time, either. On the face of it, the FTC’s case is quite sound – Watson gained FDA approval for a generic version of AndroGel in 2006 following the end of the Hatch-Waxman 30-month stay of approval, and Par after that, but did not launch, instead coming to an agreement with Solvay to postpone. However, as always, the devil is in the detail. The patent at the heart of the dispute expires in 2020, with paediatric exclusivity until 2021. Yet, the agreements see generic versions being launched from 2015; the FTC rightfully points out that this is nine years after Watson gained approval, but the firms also rightfully point out that it is five years before the patent expires. The key problem is that although ANDAs were filed with Paragraph IV certifications against the patent, the issue was settled out of court and so the validity of the patent was never tested. As a result, the patent remains in force, which backs up the companies’ argument that the settlement has enabled generic competition ahead of schedule and is therefore pro-competitive. It is hard to see how the FTC can manoeuvre around this problem, and whilst it argues, and probably correctly, that the generic firms entered the agreement not out of respect for Solvay’s patent, but because of the payments Solvay offered, with the patent untested in court, the facts as they stand do not back this up. Unless the FTC can produce compelling evidence, its suspicions will remain nothing more than a hunch.
Ian Platts - Editor, World Generic Markets
The FTC’s position has for a long time been that agreements in which a branded company essentially pays a generic competitor not to launch a competing product hampers competition and is thus illegal. As an example, in 2001, the FTC brought a lawsuit against Schering-Plough, Upsher-Smith Laboratories and American Home Products alleging such payments regarding Schering’s potassium chloride product, K-Dur 20. Despite settling with AHP, the FTC found little success in the case, with an FTC Administrative Law Judge finding the agreement had been lawful. This led to the FTC overturning the decision, despite it having been made by an FTC judge. However, in 2005, a federal appellate court again found in favour of the companies, and the decision has so far stuck. This, along with another similar decision in 2005 has led to a raft of payment agreements in the years since, which the FTC still contends harms competition by prolonging monopolies.
Given its entrenched view on the matter, it is no surprise that the FTC has again made a complaint. However, the current argument concerning AndroGel does not appear to shed any new light on the issue, and as a result, it seems unlikely that the FTC will succeed this time, either. On the face of it, the FTC’s case is quite sound – Watson gained FDA approval for a generic version of AndroGel in 2006 following the end of the Hatch-Waxman 30-month stay of approval, and Par after that, but did not launch, instead coming to an agreement with Solvay to postpone. However, as always, the devil is in the detail. The patent at the heart of the dispute expires in 2020, with paediatric exclusivity until 2021. Yet, the agreements see generic versions being launched from 2015; the FTC rightfully points out that this is nine years after Watson gained approval, but the firms also rightfully point out that it is five years before the patent expires. The key problem is that although ANDAs were filed with Paragraph IV certifications against the patent, the issue was settled out of court and so the validity of the patent was never tested. As a result, the patent remains in force, which backs up the companies’ argument that the settlement has enabled generic competition ahead of schedule and is therefore pro-competitive. It is hard to see how the FTC can manoeuvre around this problem, and whilst it argues, and probably correctly, that the generic firms entered the agreement not out of respect for Solvay’s patent, but because of the payments Solvay offered, with the patent untested in court, the facts as they stand do not back this up. Unless the FTC can produce compelling evidence, its suspicions will remain nothing more than a hunch.
Ian Platts - Editor, World Generic Markets
Friday, January 30, 2009
Warner Chilcott end Femcon and Loestrin generic challenges
Warner Chilcott has been able to resovle a number of litigation cases against its proprietary oral contraceptives, Femcon Fe and Loestrin 24 Fe. Femcon was a chewable version of Ovcon 35, an oral contraceptive that has been on the market since before 1982. The chewable version was approved by the FDA in November 2003, and was the first chewable oral contraceptive, manufactured by Bristol-Myers Squibb and marketed by Warner Chilcott. The chewable version of Ovcon 35 was granted three years exclusivity in late 2003, to expire in November 2006, and a patent was granted for the drug which does not expire until 6th April 2019. In the case of Lostrin 24, Galen originally acquired the Loestrin brand from Pfizer, and in early 2006 was granted approval for Loestrin 24 Fe; that product is protected by a patent listed in the FDA’s Orange Book which is set to expire in July 2014.
Despite the long lead times left on the two patents protecting the two oral contraceptives, Warner Chilcott has faced generic challengers for both. Barr Laboratories filed an ANDA for a generic version of Femcon Fe in April 2007, leading to a patent challenge initiated that summer. Watson Pharmaceuticals also filed an ANDA for a generic version in 2007, leading to a lawsuit filed against it in October 2007. In the case of Loestrin 24 Fe, Warner Chilcott filed a lawsuit in the US District Court of New Jersey alleging patent infringement almost as son as the drug had entered the market, with a case against Berlex and Schering AG. Warner Chilcott alleged the firms were infringing Loestrin’s patent by marketing their YAZ oral contraceptive. A few months later, in June 2006, Warner Chilcott received an ANDA notice from Watson Laboratories notifying of an application to market a generic version of the oral contraceptive, leading to another lawsuit in the New Jersey court alleging patent infringement. The YAZ litigation was settled early, in November 2006, with Schering making payments to Warner Chilcott.
Now, in a series of agreements over December 2008 and January 2009, Warner Chilcott has settled the litigation with Barr and Watson (see p. 8). The settlement with Barr concerns Femcon Fe, and gives Barr the option to launch its generic version in 2012, seven years ahead of the 2019 patent expiration. Warner Chilcott also entered into a patent settlement agreement with Watson regarding Femcon Fe. Under the terms of this, Watson will have to wait until 180 days after Barr launches its version, or January 2013, whichever comes earlier. With regard to Loestrin 24 Fe, an agreement has been made with Watson whereby Watson will be able to commence marketing its version in January 2014, or earlier if another generic enters the market. It is interesting to note that once again, a settlement has been made which effectively allows a generic firm to launch its version as an authorised generic in order to sabotage sales from a third party.
Ian Platts - Editor, World Generic Markets
Despite the long lead times left on the two patents protecting the two oral contraceptives, Warner Chilcott has faced generic challengers for both. Barr Laboratories filed an ANDA for a generic version of Femcon Fe in April 2007, leading to a patent challenge initiated that summer. Watson Pharmaceuticals also filed an ANDA for a generic version in 2007, leading to a lawsuit filed against it in October 2007. In the case of Loestrin 24 Fe, Warner Chilcott filed a lawsuit in the US District Court of New Jersey alleging patent infringement almost as son as the drug had entered the market, with a case against Berlex and Schering AG. Warner Chilcott alleged the firms were infringing Loestrin’s patent by marketing their YAZ oral contraceptive. A few months later, in June 2006, Warner Chilcott received an ANDA notice from Watson Laboratories notifying of an application to market a generic version of the oral contraceptive, leading to another lawsuit in the New Jersey court alleging patent infringement. The YAZ litigation was settled early, in November 2006, with Schering making payments to Warner Chilcott.
Now, in a series of agreements over December 2008 and January 2009, Warner Chilcott has settled the litigation with Barr and Watson (see p. 8). The settlement with Barr concerns Femcon Fe, and gives Barr the option to launch its generic version in 2012, seven years ahead of the 2019 patent expiration. Warner Chilcott also entered into a patent settlement agreement with Watson regarding Femcon Fe. Under the terms of this, Watson will have to wait until 180 days after Barr launches its version, or January 2013, whichever comes earlier. With regard to Loestrin 24 Fe, an agreement has been made with Watson whereby Watson will be able to commence marketing its version in January 2014, or earlier if another generic enters the market. It is interesting to note that once again, a settlement has been made which effectively allows a generic firm to launch its version as an authorised generic in order to sabotage sales from a third party.
Ian Platts - Editor, World Generic Markets
Monday, October 20, 2008
Apotex ships first CAMR drugs to Rwanda
Apotex has announced that its first shipment of its triple combination HIV/AIDS drug, Apo-TriAvir, is to be shipped to Rwanda. The news marks the culmination of a long process to enable the Canadian firm to produce a generic cocktail comprising drugs still under patent protection in Canada for sale solely to Rwanda utilising Canada’s Access to Medicines Regime (CAMR), formerly known as the Jean Chrétien Pledge to Africa Act. So far, Rwanda has been the only country to take advantage of the regime, which Canada brought in to align its patent laws with the World Trade Organisation’s framework to enable generic copies of patented drugs to be shipped to countries in need.
Whilst Apotex has been understandably pleased with itself for seeing the process through, it has nonetheless been critical of the Access to Medicines Regime, noting that the regime is too complex and problematic. Apotex is clear that the regime needs to be changed in order for it to be workable, and has previously suggested that it would not be willing to utilise it again in the future. Indeed, the regime has come in for criticism since its conception for being too bureaucratic and long-winded by a number of organisations; the difficulties involved in using it can be seen by the fact that the law has been in place since 2004 and in force since 2005, yet this is the first time it has been used.
Clearly, the experiences of the one company that has used the regime would show that changes need to be made to it, and the Canadian Parliament would do well to take another look at the legislation, using Apotex’ experience to see what changes could be made. However, before being quick to condemn, it is worth noting that the regime was introduced after a great deal of consultation from organisations with interests across the spectrum of pharmaceutical manufacturing and distribution. It was created to try to balance the needs of access to affordable drugs against the necessity of protecting patent law, and so it is somewhat inevitable that a law that tries to keep contradictory forces balanced will be difficult to use. Whilst that does not mean that changes cannot be investigated, it does mean that the resulting process will never be likely to please all interested parties. It is also worth noting that however difficult Apotex has found the process, this is still the first time any such law has been used in the world, and Canada still deserves credit for being the first country to try to amend its laws to enable its pharmaceutical manufacturing skills to be used to help developing countries in need. Canada should move to cap this achievement by making the law more workable.i to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.
Ian Platts - Editor, World Generic Markets
Whilst Apotex has been understandably pleased with itself for seeing the process through, it has nonetheless been critical of the Access to Medicines Regime, noting that the regime is too complex and problematic. Apotex is clear that the regime needs to be changed in order for it to be workable, and has previously suggested that it would not be willing to utilise it again in the future. Indeed, the regime has come in for criticism since its conception for being too bureaucratic and long-winded by a number of organisations; the difficulties involved in using it can be seen by the fact that the law has been in place since 2004 and in force since 2005, yet this is the first time it has been used.
Clearly, the experiences of the one company that has used the regime would show that changes need to be made to it, and the Canadian Parliament would do well to take another look at the legislation, using Apotex’ experience to see what changes could be made. However, before being quick to condemn, it is worth noting that the regime was introduced after a great deal of consultation from organisations with interests across the spectrum of pharmaceutical manufacturing and distribution. It was created to try to balance the needs of access to affordable drugs against the necessity of protecting patent law, and so it is somewhat inevitable that a law that tries to keep contradictory forces balanced will be difficult to use. Whilst that does not mean that changes cannot be investigated, it does mean that the resulting process will never be likely to please all interested parties. It is also worth noting that however difficult Apotex has found the process, this is still the first time any such law has been used in the world, and Canada still deserves credit for being the first country to try to amend its laws to enable its pharmaceutical manufacturing skills to be used to help developing countries in need. Canada should move to cap this achievement by making the law more workable.i to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.
Ian Platts - Editor, World Generic Markets
Friday, May 16, 2008
Intellectual protection issues come to the fore
Intellectual property issues have been a hot topic for various governments over the last few weeks, with significant developments occurring in Brazil, the Philippines and India. Earlier in April, the Brazil Health Ministry declared the antirretroviral drug tenofovir to be in the ‘public interest’, signalling its willingness to import a generic version of the medicine. The Health Ministry’s declaration indicates that the patent for the drug could be rejected due to its high price; this could then lead to negotiations over the import of a generic version.
At the end of last month, the Philippines also turned against branded manufacturers, with its Congress approving a bill that strongly promotes generic medicines. The new law, which still requires approval from the President, will allow limited parallel importation, should help to prevent incremental innovation, will allow local generic firms to register their versions before patent expiry, and could permit the use of compulsory licences for the public good.
Conversely, one region which has traditionally been without strong intellectual protection laws for years, India, is now looking to clamp down on marketing approvals of drugs already patented. The Drug Controller General of India has published a reference guide and hopes to co-ordinate with the Ministry of Health to create an integrated approach which will link patents together. Following this, the DCGI will then prevent any approvals for generic versions of patented drugs. To date, patent linkage in India has proven difficult, as it has been impeded by a decentralised and inefficient drug approval structure. Unsurprisingly, domestic firms in the country are against such moves, arguing that they will be unworkable in practice.
The motivation behind moves to promote generics through intellectual property reforms are clearly motivated by the high costs of patented drugs. Interestingly, think-tank African Liberty has recently questioned the link, noting that low uptake of drugs was more likely caused by poor infrastructure. Either way, governments in developing countries are likely to continue putting pressure on IP rules, as weakening them in favour of generics appears to provide them with a quicker fix to long term drug expenditure problems.
Jonathan Way - Editor, World Generic Markets
At the end of last month, the Philippines also turned against branded manufacturers, with its Congress approving a bill that strongly promotes generic medicines. The new law, which still requires approval from the President, will allow limited parallel importation, should help to prevent incremental innovation, will allow local generic firms to register their versions before patent expiry, and could permit the use of compulsory licences for the public good.
Conversely, one region which has traditionally been without strong intellectual protection laws for years, India, is now looking to clamp down on marketing approvals of drugs already patented. The Drug Controller General of India has published a reference guide and hopes to co-ordinate with the Ministry of Health to create an integrated approach which will link patents together. Following this, the DCGI will then prevent any approvals for generic versions of patented drugs. To date, patent linkage in India has proven difficult, as it has been impeded by a decentralised and inefficient drug approval structure. Unsurprisingly, domestic firms in the country are against such moves, arguing that they will be unworkable in practice.
The motivation behind moves to promote generics through intellectual property reforms are clearly motivated by the high costs of patented drugs. Interestingly, think-tank African Liberty has recently questioned the link, noting that low uptake of drugs was more likely caused by poor infrastructure. Either way, governments in developing countries are likely to continue putting pressure on IP rules, as weakening them in favour of generics appears to provide them with a quicker fix to long term drug expenditure problems.
Jonathan Way - Editor, World Generic Markets
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