Index: Pharma Industry Improves On Access To Medicines, Needs Work On Ethics, Patent Disclosure 17/11/2014 by William New, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The 2014 edition of an independent ranking of leading pharmaceutical companies’ efforts to help developing countries released today found new initiatives undertaken in the past two years. But it said corruption and insufficient disclosure of existing patents continue to plague the industry. The 2014 Access to Medicine Index is available here. The Index is published every two years. The organisation is based in the Netherlands. Funding for the report came from the Gates Foundation, and the governments of the Netherlands and the United Kingdom. GlaxoSmithKline scored highest in the ranking for the fourth time. Most improved was Novo Nordisk, advancing in five of the seven areas measured, to move up from sixth to second. GSK “has an innovative business model focused on Africa, a large relevant portfolio, a large share of its pipeline dedicated to relevant diseases, and numerous access-oriented intellectual property sharing partnerships,” the Index organisation said in a release. Sanofi and Pfizer, meanwhile, dropped the most in the rankings, it said, while Astellas, Daiichi Sankyo and Takeda “remain at the bottom of the league.” According to the release, the Index “scores companies on their performance, innovation, transparency and commitments across seven areas of activity considered key to improving access to medicine. The companies are graded on 95 factors covering these areas, including product research and development, to what extent they facilitate or resist efforts to create generic versions of their drugs, and how they approach pricing in developing countries. Lobbying activities, marketing ethics and product donations and other philanthropic activities are also evaluated.” Improvements cited by the Index included various means of charging developing countries for products. Companies are “paying more attention to socioeconomic factors, such as people’s ability to pay, increasingly tailoring prices within countries.” It said that since the last report in 2012, there are 47 more products in the pipeline that are “appropriate for developing countries.” In addition, it said, more companies are experimenting with innovative access-oriented business models. Three companies have introduced new models and three have expanded pilots, it said. Also, companies are “granting more licences to developing country companies to make and distribute generic versions of their medicines.” Meanwhile, the report said, “policies and activities to improve access to medicine continue to get better organised.” “All 20 companies [in the Index] now have some form of board-level representation for access-to-medicine issues, and more companies are linking performance incentives to medicines access. On research and development (R&D), the 2014 Index “reveals how concentrated the relevant R&D is.” Just five companies are developing 54% of the 327 products in the pipeline, it said. All disease classes are being targeted, but more than half of the products under development target just five diseases: lower respiratory infections, diabetes, hepatitis, HIV/AIDS and malaria. Wim Leereveld, founder and CEO of the Access to Medicine Index, said of the report: “No company is in the top five in all areas we analyse, but the leaders tend to perform well across most of them, even though they differ in their focus. Top performers innovate constantly, and usually have to innovate in several areas to maintain their position.” The report had a number of advisers in its preparation. A top strategist for the Index is former senior World Health Organization official Hans Hogerzeil (IPW, Public Health, 18 March 2014). Patents and Licensing One of the areas analysed relates to patents and licensing. A summary of the findings is as follows: • Companies remain conservative in their disclosure of where patents are active and when they will expire – information that is very useful to medicine procurers and generic medicine manufacturers. No company independently and publicly disclosed patent statuses for products relevant to the Index. • Pro-access licensing agreements increase in number, with two more companies entering licensing agreements for products targeting relevant diseases, bringing the total to eight. • The overwhelming majority of licenses are still for HIV/AIDS products, but there are early signs that some companies are taking steps to expand voluntary licensing to other diseases. • Company support for pro-access intellectual property law is limited, but even the cautious company public stance is undermined by private lobbying against flexibilities in the TRIPS agreement. (TRIPS refers to the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.) On patents and licensing, the Index was fairly negative, but pointed to a bright spot, stating that “pro-access company management of intellectual property has improved, albeit mostly in one particular area: HIV/AIDS licences agreed through a third party, the Medicines Patent Pool.” The report discussed the need to not repeat past problems of high pricing on patented products inhibiting access to needed drugs, for instance in the case of hepatitis C. “Chronic hepatitis deaths will soon exceed HIV/AIDS-related deaths. There are currently many products in the pipeline for hepatitis C, and these will be entering the market in the next few years,” it said. “However, just as the cost of antiretrovirals (ARVs) hampered access in the mid-1990s, the prohibitive cost of treatment in this disease is a looming challenge. New mechanisms to ensure affordable medicines, incentives for innovation and new mechanisms for ensuring competition (such as those developed by the Medicines Patent Pool for HIV/AIDS) need to start.” The report also looks back to the lesson of the 1990s in South Africa, when the pharmaceutical industry’s reputation took a big hit for forcefully attempting to enforce patents in the face of the AIDS crisis there. The report mentioned the case since 2012 in South Africa in which a document was leaked showing plans to pursue strong strategies that again might have had negative consequences for access in the region. It notes that some of the companies it reviewed were involved in that recent effort and have since dropped out. The report cited examples of new access-oriented business models, including: Merck & Co. offering patients in 11 cities in India zero-interest loans for the purchase of one of its hepatitis medicines; and Novo Nordisk making insulin products more accessible in India, Nigeria, Ghana and Kenya by identifying ways to integrate diagnosis, treatment and control in local communities.” However, it said, “the impact of such models remains to be seen.” The Index also takes a shot at Merck & Co. and Johnson & Johnson for slipping in the ranks. “Johnson & Johnson and Merck & Co. have both dropped substantially since 2012,” it said. “They both exhibit low levels of disclosure and have weaker policies on patenting in countries of interest to the Index. Although they both engage in voluntary licensing, they do so proportionally less than their peers, and are opaque about the terms of engagement.” “In addition,” it said, “they pledge limited support for the flexibilities set out in the TRIPS agreement, which is complicated further by evidence of lobbying.” The patents and licensing chapter opens with the advice that: “Companies can limit the impact of patent monopolies on low income patients by applying a nuanced approach to IP management and taking steps that support the entry of generic medicine manufacturers. They can refrain from patenting or from enforcing existing patents in certain territories. They can ensure they register products where they are needed. Where generic medicine markets are absent, they can modify prices to stimulate market creation. Where there is market potential, they can enter pro-access licensing arrangements. They can also provide an overview of where patents are active and where they will be enforced (which would support both generic medicine manufacturers and procurement agencies), and disclose whether licensing agreements exist, as well as their terms and conditions.” Some highlights from the Patents and Licensing chapter, as outlined by an Index official, include: Leaders “Gilead and GSK lead within this chapter. These companies commit to taking a more balanced approach to IP management, and acknowledge the pressing need for companies to explore new ways of using licensing to improve access to medicine for low income people in middle income countries.” Laggards “Laggards lack clear commitment. Astellas and Takeda occupy the bottom positions. Although Astellas and Takeda have relevant patented products, they do not make the same level of commitment to refraining from seeking or enforcing patents in relevant countries. Neither do they commit to engaging in licensing. They take a comparatively conservative stance on the flexibilities set out in the TRIPS agreement.” Limited Support for Pro-Access IP Law, Undermined by Private Policy Positions “Publically, companies generally give only qualified support to the flexibilities intended to protect public health set out in the internationally agreed intellectual property framework. However, even this cautious public stance is undermined by evidence of efforts to lobby against these flexibilities in private.” Pro-Access Licensing Agreements Increase in Number “Since 2012, two more companies have entered licensing arrangements for products for diseases in scope, bringing the total to eight. The Index captured evidence of almost 250 licences relating to diseases in scope. Compared to 2012, a larger proportion of licences include pro access terms and are publicly available. Innovation is also apparent, with the Medicines Patent Pool playing a key role: for example in the use of tiered royalties in middle-income countries.” Early Signs that Licensing can be Expanded to More Diseases “The overwhelming majority (93%) of licences identified remain related to antiretrovirals (ARVs) for HIV/AIDS. However, there are early signs that some companies are making steps toward expanding voluntary licensing practices beyond this disease, for example to cytomegalovirus and hepatitis C.” Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related William New may be reached at email@example.com."Index: Pharma Industry Improves On Access To Medicines, Needs Work On Ethics, Patent Disclosure" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.