Joint submission from Global Health Law Groningen Research Centre, Faculty of Law & the Global Health Unit, Dept. of Health Sciences, University Medical Centre at the University of Groningen. Submission prepared by ’t Hoen E., Perehudoff K., Moye Holz D., Gispen M.-E., Toebes B., and Hogerzeil H.
Patterns in global financing, regulatory measures by governments, and company behaviour have influenced access to innovative medicines over the last decade. The Global Fund to Fight AIDS, Tuberculosis and Malaria, the United States President's Emergency Plan for AIDS Relief, and Unitaid have attracted and distributed major funding to improve access to these medicines while international (donor) funding has neglected the development and provision of medicines for non-communicable diseases (NCDs) to the low-resourced nations. There is little public support and funding for patient/non-governmental movements in the NCD field, leaving a gap that is filled by industry (i.e. evidenced by the spread of industry-funded patient organisations).
A proliferation of incentives based on market exclusivity (patents, supplementary protection certificate, orphan drug legislation, data exclusivity) have resulted in high prices. Underdeveloped/ill-equipped government pricing and reimbursement mechanisms have not kept pace with the development of innovative medicines for small patient populations. Decision makers have failed to capitalise on governments’ negotiating power as large volume purchasers.
Company behaviour/strategy to market drugs for narrow indications has resulted in smaller patient groups, or exploitative dominant market positions, limiting negotiating power and leading to price gouging. (1) In the short term, these measures result in unaffordable essential medicines, leading to rationing or delayed access (2) and triggering domestic litigation for patient access (3). Recently criticism was heard from physicians, specialists, and consumers (4). The crisis in access led regulators in Italy to condone the foreign purchase and import of lower priced medicines. (5)
innovative medicines while maintaining financial sustainability of health systems?
Governments have the undeniable obligation to ensure sufficient funding, infrastructure, and regulation is in place to guarantee universal access to innovative medicines proven to be a therapeutic advance. High prices commanded by pharmaceutical manufacturers jeopardise universal access to innovative medicines and health systems have neither strong institutions and capacity to rigorously assess such medicines nor the regulation to control prices. (6) Some governments are reluctant to issue licenses when patent monopolies are abused. Patient access schemes (i.e. managed entry, pay per performance, etc.) promoted by the pharmaceutical industry can stimulate the consumption of medicines of unproven benefit and offer neither long-term solutions for access nor sustainability.
First, governments should embrace their legal obligation and moral responsibility to realise universal access to medicines of proven therapeutic value. The limited health impacts of many medicines do not justify their expense; however, real innovations that offer health benefits, as a matter of principle, cannot be withheld from patients in need.
Thereafter, OECD countries should:
Wirtz et al. Lancet 2016
2016 submissions to the UN High Level Panel by ’t Hoen et al.
2016 Human Rights Council Resolution (A/HRC/32/L.23/Rev.1)
2017 European Parliament Resolution (2016/2057(INI)
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