Read this article in Italian here.

Italy is now serving a three-year term on the World Health Organization (WHO)’s Executive Board, a key decision-making body that guides the WHO’s work on global health. Alongside thirty-three other countries on the Executive Board, Italy will attend the 144th session of the Executive Board in January 2019 to discuss topics ranging from polio eradication to the health implications of climate change.

But perhaps the most important topic on the Executive Board’s agenda is the WHO’s proposed Roadmap on Access to Medicines. This Roadmap sets priorities for the next five years of the WHO’s work on medicines around the world. As an Executive Board member, Italy will help shape the discussion about how the WHO should approach this issue.

Unfortunately, the WHO’s Roadmap, drafted by the WHO’s career staff, has serious problems that Member States need to fix. For example, the Roadmap envisions a WHO role advising countries on how to weaken intellectual property, such as by granting “compulsory licenses” (sometimes called “TRIPS flexibilities”) to allow the manufacture of patented medicines without the patent owners’ consent. This is unnecessary and would gravely harm global innovation – making it harder for patients to access today’s medicines and undermining investment in tomorrow’s new treatments and cures.

The WHO’s career staff appear to believe that patents are a barrier to access.  But this isn’t true: research has found no correlation between intellectual property and access to medicines.  Nearly all the drugs the WHO deems “essential” are already off-patent yet still out of reach for millions due to other factors, such as weak and underfunded health care systems.  Strengthening IP can actually facilitate access, both by stimulating new discoveries and making it easier for innovative medicines to reach patients that need them.  

The WHO is also ill-suited to make these recommendations: it lacks the expertise to advise countries on the complex technical, economic and trade implications of intellectual property (IP) protections. Many countries have already raised concerns that the WHO should not spend its limited resources working on such polarizing tasks that are unlikely to improve access to medicines.

WHO Executive Board members need to step up—and speak out—about the vital role of IP in spurring new discoveries. In the past, Italy has promoted a global innovation ecosystem and encouraged world leaders to recognize the important role innovation plays in helping nations and patients. Italy has tried to lead by example by investing in innovation, though there is potential for additional support within its borders and around the world.

Take Italy’s patent figures, for example. In 2016, Italy filed 131 biotechnology patents under the Patent Cooperation Treaty, which was in line with its figures for several years prior. Also in line with previous years are the most recent figures of research and development (R&D) investment, which totaled $26.1 billion. The theme of stability continues when considering Italy’s global innovation rankings; Italy came in at 31st in the world in the 2018 Global Innovation Index, “performing at expectations for level of development” and just two spots lower than its 2017 and 2016 rankings.

Italy understands the critical role innovation plays in helping patients. The country’s statements in recent international meetings and official channels show it values promoting and protecting the knowledge, IP and entrepreneurship that drive global innovation.

• During WIPO’s Assemblies of the Member States 58th Series of Meetings, Italy spoke to WIPO’s support of a “global, balanced and effective IP system” and how the country “strongly believes that such a system should be built up by ensuring growth of all the systems administered by WIPO, ensuring adequate protection for all forms of intellectual property, patients, trademarks [and] copyrights.”
• Italy has acknowledged the real barriers that hamper access to medicines. In Italy’s National Sustainable Development Strategy 2017/2030, the country commits to “achiev[ing] universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all,” and to “substantially increas[ing] health financing and the recruitment, development, training and retention of the health workforce in developing countries.”

But Italy can do more to defend the IP protections that have played such a major role in its own economy.  Unfortunately, when Italy provided written feedback to the first draft of the WHO’s Roadmap on Access to Medicines, it failed to point out issues with the proposals to deepen the WHO’s work on problematic IP issues, such as TRIPS flexibilities.  Although some countries, like the United States and Germany, raised concerns or conveyed views about the need to value IP’s role in stimulating innovation, Italy remained silent.

As the WHO Executive Board considers how to improve access to medicines, Italy has an opportunity to rebut the idea that weakening IP will do anything to improve access, as well as help focus the WHO on tackling the real barriers to access, such as weak and under-funded health care systems, poor infrastructure and taxes/tariffs. In particular, Italy should speak out clearly at the Executive Board meeting to convey concerns about the Roadmap and ensure it does not lead to expanded WHO activities that would undermine IP globally.

Now’s the time to act. Patients around the world depend on Italy and the other Executive Board members to lead the charge on proactive and comprehensive solutions that address the real and complex obstacles to improved global health.