Source: PharmaLetter | October 18, 2016
In our weekly expert view piece, Rohit Malpani, director of policy and analysis for Mèdecins Sans Frontiéres Access Campaign, discusses the UN Secretary General’s High-Level Panel report on Access to Medicines and looks at the responsibilities it places on industry.
During the UN General Assembly in New York last month, the UN Secretary General’s High-Level Panel on Access to Medicines released its much-anticipated report, containing recommendations for governments and the pharmaceutical industry on how to enable better access to medicines and vaccines and how to ensure medical research and development (R&D) addresses unmet priority health needs.
As a medical humanitarian organization, we confront the effects of a lack of innovation for many diseases affecting patients on a daily basis, and we and our patients continually struggle to overcome barriers, like high prices, that prevent widespread access to needed medical tools.
“Pharmaceutical corporations must stop pursuing harmful pricing and access policies and ensure their drugs are registered, for whatever treatment indication is needed, in each country”
We’re encouraged that Panel Members representing government, industry, civil society and academia presented a set of strong recommendations that, if implemented, can improve health outcomes worldwide.
Now the UN Secretary General, governments, and industry must transform these recommendations into action. Whether it’s the sky-high prices of medicines to treat hepatitis C, or a lack of innovation on new tools to treat emerging infections like Ebola, which took more than 11,000 lives during the last outbreak, the cost of continued inaction is deadly.
Each day, MSF staff see small children who are gravely ill with pneumonia because the vaccine that could prevent it is too expensive for their government or for MSF to afford.
We see the emergence of drug-resistant bacteria in war-wounded, burn patients and newborns in places like Iraq, Pakistan and Haiti, including infections that can only be treated with the very last lines of antibiotics. Drug-resistant infections already kill 700,000 people globally each year, yet it has been more than 30 years since a new class of antibiotics was introduced, and the pipeline for critically needed new antibiotics is nearly empty.
Report does ‘not go far enough’
The cost is not only in human lives and a public health disaster that causes unnecessary suffering for millions, but it’s also increasingly viewed as an economic challenge – drug-resistant infections are forecast to have lost the world’s economy US$100 trillion by 2050. MSF broadly welcomes the panel’s recommendations on the need for new incentives for R&D and for greater transparency, but in some cases we wish the report had gone further.
For example, the report did not go far enough in supporting essential government and civil society efforts to increase access to existing medicines. While the report does caution against damaging intellectual property rules included in trade agreements, it could have more strongly urged countries to stop pursuing longer monopolies on life-saving medicines through trade agreements like the Trans Pacific Partnership Agreement (TPP), a US-led trade agreement that is the worst-ever trade agreement for access to medicines.
Nevertheless, we recognize the report is a product of a compromise, given the diverse interests of the panel members. On the positive side, the report suggests some measures that governments can already take now to improve access to existing medicines, including taking advantage of legal provisions called ‘TRIPS flexibilities’ to their fullest extent, reforming patent laws if need be, and empowering governments and civil society to use these provisions.
The report also pointed out that the World Trade Organization could employ its trade policy review process to enable greater transparency and action against countries that seek to undermine the use of TRIPS flexibilities. The call for greater transparency of R&D investments, patenting and pricing decisions, and the recognition that there is a need to reform incentives for innovation are perhaps some of the strongest recommendations.
The panel’s strong recommendation to implement new approaches to R&D that de-link, or separate, the financing of R&D from the end product price aligns with the approach governments have endorsed for R&D into new antibiotics to tackle antimicrobial resistance – including in a recent UN Political Declaration on AMR. Linking investments in R&D to the expectation of high sales prices through granting patent monopolies is the key driver of drug development today. This means that corporations make R&D investments based on whether high prices can be expected in return, while ignoring the pressing health needs of millions of people who are considered too poor.
The concept of de-linkage breaks the dependence on high prices and monopolies to enable R&D driven by health priorities. The report concludes that government action and regulation are urgently needed, as governments are ultimately responsible for managing medical needs for people. Governments around the world, including in the US and Europe, are becoming more acutely aware of the challenges posed by the rising prices of medicines and yet they continue to grant often unwarranted patent monopolies that allow pharmaceutical corporations to charge those high prices in the first place.
Protecting and promoting health and well-being
Governments face a tremendous challenge to create an environment that balances innovation rewards with public health needs. But pharmaceutical corporations can also implement some of the recommendations today, for example by reducing the price of medicines and vaccines for countries and for organisations serving the world’s most vulnerable people – such as humanitarian organisations working with refugees.
Pharmaceutical corporations can also stop pursuing harmful pricing and access policies and ensure their drugs are registered, for whatever treatment indication is needed, in each country. Most importantly, pharmaceutical companies must not stand in the way of governments that seek to take steps to ensure that people have access to affordable medicines and vaccines, both now and in the future.
Ultimately governments are responsible for protecting and promoting health and well-being, and must demonstrate leadership and take action to implement the report’s recommendations. Whether we work for a government, a non-profit organisation or a pharmaceutical company, the net effect is the same; if we can’t afford the medical tools we need, or if they simply don’t exist, then who does medical R&D actually benefit?