By Ellen ‘t Hoen
As the world gathers in Amsterdam for the 22nd International AIDS Conference, high medicines prices are again making headlines across the world. Ellen ‘t Hoen takes stock of where we are almost two decades after HIV propelled these issues to the top of the international agenda.
High medicines prices are making headlines across the globe. Today, the highest advertised price for blindness treatment Luxterna is set by the company Spark Therapeutics at US$ 850,000. The rationing of essential hepatitis C (HCV) medicines became common practice even in high-income nations where they were deemed cost-effective but not affordable. People living with HCV in several European countries are encouraged to seek treatment through direct importation with the help of buyers clubs or through medical tourism to countries where patents are absent and generic treatments are available. The price of new cancer medicines and treatments at US$ 100.000 a year is now common practice. Access to medicines has become a global issue affecting even the wealthiest nations – and we need a global response to find solutions.
It is therefore no surprise that people look to the successful efforts to bring down the price of antiretroviral medicines to find answers to today’s high drug price challenges in regard to other diseases. The key to the successful lowering of ARV prices was a flexible approach to antiretroviral medicines patents – for example, through the use of TRIPS flexibilities in procurement, patent oppositions, licensing, in particular through the Medicines Patent Pool – and the availability of global and local financing for the procurement of those medicines that created a competitive market for generic producers.
A decade ago one would not have expected the Dutch Minister of Health to announce plans to examine how compulsory licensing of medicines patents may serve as a strategy to decrease the prices of new patented medicines. Calls for the use of compulsory licensing of patents of medicines can be heard in France, Greece, Ireland, Romania, the UK, Spain, and the US. These calls are mostly motivated by the urgency to lower the price of rationed (and in some cases bankrupting) products for the treatment of HCV and cancer.
Based on the HIV experience, there is no doubt that addressing the barriers to generic entry through the use of TRIPS flexibilities, such as compulsory licensing, can be effective. The question is whether it will be politically feasible, in light of the fierce opposition from the pharmaceutical industry to such plans. While the industry has shown flexibility concerning HIV in low-income countries, it is unlikely that it will do so in a country like the Netherlands.
So where do we go from here?
High medicines pricing have their roots in the financing model of pharmaceutical research and development, which is predominantly based on the granting of market exclusivities through patents or otherwise. This is not a situation we can ‘compulsory license’ ourselves out of.
At the launch of the report by the Lancet Commission on Essential Medicines, Dutch Minister for Foreign Trade and Development Cooperation Liliane Ploumen and Minister of Health Edith Schippers proclaimed the current innovation system for pharmaceuticals to be broken. They wrote: “Patent and intellectual property exclusivities are the only cornerstone of the current model. Companies can ask the price they like. This will no longer do. We need to develop alternative business models. And if public money is used for the development of new medicines, agreement upfront is needed about what this public investment will mean for the final price. We believe that companies must provide full transparency regarding the costs of research and development (R&D).”
The development of new medicines is costly. The investment in innovation needs to be protected and promoted, but not at the expense of access that affects the most vulnerable. Considering the amount of money the world spends on pharmaceuticals, it is time for some fresh thinking about how to ensure the development of new essential medicines takes place while assuring those medicines are affordable and accessible to all. Global spending on pharmaceutical products is expected to reach US$ 1.4 trillion by 2020 [i]. If even a small part of this money (raised through individuals and health systems paying for the drugs), could be allocated to drug development directly we could guarantee both innovation and access. After all, if the R&D is already paid for there is no need for market exclusivities to recoup the innovation cost. This is called the “delinkage” proposal. For example, governments can create prize funds for the development of certain priority health technologies. Such funds should ensure significant amounts of financing for R&D are available and thereby create a ‘market’ for R&D. Delinkage is not about taking money away from drug development. It is about making sure needed R&D takes place and that the results of that R&D are available to all.
For this to happen we will need a global movement based on solidarity. That is perhaps the most important lesson we can learn from HIV.
- Ellen ‘t Hoen is a lawyer and public health advocate with more than 30 years experience in health and intellectual property. She is the author of the book ‘Private Patents and Public Health’.
 Better life through medicine—let’s leave no one behind, Ploumen, Lilianne et al.The Lancet , Volume 389 , Issue 10067 , 339 – 341