Pan-American patients speak out on innovation and global health
In the debate on medical innovation, the interest of patients has been neglected
Click here to see a picture from this meeting of Pan-American patient groups.
Ottawa, ON (October 23, 2007) – Yesterday, Durhane Wong-Rieger (Chair of the Consumer Advocare Network) and other patient groups from across the Americas came together to send a common message to the World Health Organization (WHO) – the continued development of new medicines for all patients is essential and must be encouraged by ensuring incentives for innovation and by providing resources to access. This announcement coincides with a meeting of World Health Organization (WHO) delegates from the Americas Regions, who are gathering in Ottawa to discuss the draft strategy and action plan of the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).
“While this draft strategy was intended to address the need for new treatments and to improve access to medicines in developing countries, patient groups fear that components of the proposed plan will have serious negative consequences for all patients,” says Durhane Wong-Rieger, Chair of the Consumer Advocare Network.
“To date, patients have been left out of this discussion, which has been driven mainly by vested interests of other stakeholders. We reject the efforts to polarize this issue as the interests of patients in developed countries versus those in developing countries. As patients, we realize our common needs and will not allow others to ignore us,” cautions Ms. Wong-Rieger.
The Patient Perspective
“The Brazilian Cancer Association (BCA) is one of many groups that are extremely disappointed that patients and patient groups have not been actively encouraged to participate and offered the necessary support to do this effectively from the outset of this process,” says Marilia Casseb of the BCA.
“The lack of patient engagement is even more troubling when you consider that a fundamental premise of patient-centred care – a concept endorsed by the WHO – is that patients and patient groups are involved in all stages of healthcare decision-making, including setting of international policy,” states Ms. Casseb.
Flaws in the IGWG Process
“The lack of patient consultation is only one of the flaws in the IGWG process,” says Dr. Kristina Lybecker, Assistant Professor of Economics, Colorado College. “While the WHO’s goals are laudable, the premises that underlie the conceptualization of the problem are faulty. The assumption that patients in developing nations do not have the drugs they need because of intellectual property rights is fundamentally unsound.”
“Unfortunately the problem is far more nuanced and complicated than this,” explains Dr. Lybecker. “While overestimating the role of intellectual property rights, the plan downplays a host of other factors that prevent developing country patients from getting the drugs they need: inadequate medical infrastructure, insufficient political will, a shortage of clinical trials in nations where neglected diseases are endemic, poverty, and insufficient market incentives. Of these, poverty and the lack of market incentives are largely the source of insufficient access and the absence of innovation.”
Intellectual Property, Innovation and Access
“It is unfortunate that the draft action plan is based upon the premise that intellectual property rights impede access to new therapies,” says Dr. Rene Rodriguez, President of the Inter-American College of Physician and Surgeons. “As medical practitioners, we see firsthand the benefits conferred by innovative pharmaceutical therapies and we recommend the WHO not consider measures that weaken global IPR. We believe that patent protection is the cornerstone of medial innovation.”
Innovation and Rare Disorders
Ed Koning, patient and President of the Canadian Fabry Association pointed out, “There is probably no greater testament to the importance of strong patent protection to stimulating research into unmet needs than the ‘orphan drug’ legislation, introduced in the United States in 1983.”
Previously, drug researchers had ignored rare disorders (affecting fewer than 1 in 1,333 persons) because there was insufficient market incentive. To address these unmet patient needs, the US Orphan Drug Act provides tax and market incentives. The results have exceeded expectations, with over 300 orphan-designated products brought to market since legislation (as compared to only 34 in the previous decade), and over 1700 orphan designations awarded.
The value of market-based incentives is underscored by similar orphan drug legislation in Japan and European Union, among others.
Improving Access
Participants also decried the lack of initiatives to improve access to drugs in poor countries.
According to a research paper by Professor Amir Attaran of the University of Ottawa, only 17 of the 319 drugs on WHO’s list of essential drugs are patented in countries where four billion of the world’s low- and middle-income patients live. This clearly demonstrates that patents are not the main barrier to access to medicine in poor countries.[1]
Participants urged WHO to adopt access initiatives such as the non-profit GAVI Alliance, which purchases vaccines and distributes these to patients in over 60 developing countries.
Recommendations
Other recommendations that are supported by many Pan-American patient groups include:
- Ensure strong incentives for continued R&D and innovation.
- Ensure continued incentives for R&D into neglected disorders both rare diseases and those affecting developing countries.
- Support strategies to improve access to safe treatments.
- Ensure effective healthcare infrastructure in developing countries to prevent disease and optimize use of medicines.
“Despite criticisms of the IGWG plan, patient groups in general – including the Consumer Advocare Network – support the WHO’s efforts towards developing a global strategy to improve global medical innovation and access,” says Ms. Wong-Rieger. “Moving forwards, it is essential that that WHO not proceed with recommending changes to IPP as it relates to medical R&D and healthcare until patient groups have had the opportunity to be educated and directly engaged. Other groups, however well intentioned, do not speak on behalf of patients.”
About the WHO’s Intergovernmental Working Group (IGWG)[2]
May 2006, Member States asked WHO to establish an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The Working Group's mandate is to prepare a global strategy and plan of action on essential health research to address conditions affecting developing countries disproportionately. The resulting global plan of action will be presented to the World Health Assembly in mid-2008.
About Consumer Advocare Network[3]
The Consumer Advocare Network is a national network of healthcare consumer organizations and individuals in Canada whose mission is to ensure that the Canadian health care system is driven by consumer needs. This is accomplished through education, advocacy and ensuring that healthcare providers and other stakeholders work effectively with consumers, consumer groups, and consumer advocates as equal, legitimate partners.
[1] How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries? Health Affairs, 23, no. 3 (2004): 155-166 – http://content.healthaffairs.org/cgi/content/full/23/3/155
http://www.canadianbusiness.com/markets/cnw/article.jsp?content=20071023_082512_7_cnw_cnw
