Medicines Patent Pool signs first cancer deal — but there's a catch

The Medicines Patent Pool has signed its first agreement to make a cancer treatment more accessible in low- and middle-income countries — but because only a small number of patients are expected to benefit from the deal, its significance is being hailed as largely symbolic by advocates. The voluntary licensing agreement is for nilotinib, a lifesaving drug that is used to treat chronic myeloid leukemia, or CML, and is listed as an essential medicine by the World Health Organization. It is being promoted as a breakthrough in several ways. It’s MPP’s first deal with Swiss pharmaceutical giant Novartis. It is also its first license agreement targeting a noncommunicable disease. And it’s the first time a company has licensed a patented cancer medicine through a public health-oriented voluntary licensing mechanism. “This voluntary licence in the non-communicable disease space sets a vital precedent that I hope other companies will follow.” --— Charles Gore, executive director, Medicines Patent Pool But the main patent on nilotinib is due to expire in only nine months' time. With the generic manufacturers not yet selected, it is unlikely that any drugs will be produced before then. In addition, the voluntary license covers only 44 countries. Seven of these — Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia — have additional existing or pending patents on nilotinib, some of which extend for several years. The main benefit of the agreement is that it will allow generic manufacturers to supply nilotinib to these seven middle-income countries much earlier than they otherwise would. It also provides legal certainty that they can supply the product to the other 37 countries on the list. Despite the limitations, advocates hope it will set a precedent for further deals as noncommunicable diseases become a growing concern in the global south. Charles Gore, MPP’s executive director, said: “Although the remaining patent life is relatively short, this voluntary licence in the non-communicable disease space sets a vital precedent that I hope other companies will follow.” In an interview with Swissinfo, he added: “In terms of the number [of patients] this isn’t a huge deal but in terms of what it represents, it is a big deal because it’s never been done before.” He said that MPP is in discussions about voluntary licenses for other cancer drugs. Benedikt Huttner, secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, added: “We hope this marks the start of a paradigm shift with more pharmaceutical companies following suit with licence agreements for essential patented cancer medicines to help ensure that patients globally can benefit.” Novartis will be passing on the royalties of 5% from generic sales to the Access to Oncology Medicines Coalition, a new public-private partnership that helped to facilitate the deal. With drugs like nilotinib, chronic myeloid leukemia is now possible to control so effectively that “patients can expect to live life-spans nearly as long as normal healthy adults,” according to the Leukemia and Lymphoma Society. But in low- and middle-income countries, mortality rates are far higher. The largest number of deaths occur in India — which is not included in the license — and the highest death rate is in Ethiopia — which is included — according to a study of 2019 data. The first port of call for CML treatment is a drug called imatinib, the patent for which has already expired. But some patients are intolerant of imatinib, and the cancer can also become resistant to it, which is where nilotinib comes in. It is required in about 20% of cases. Patients must take nilotinib twice a day for the rest of their lives. At a cost of tens of thousands of dollars a year, it has remained out of reach for many people around the world. The new licensing agreement could reduce the cost and make it more widely available in countries where the drug hasn’t previously been registered, but it is just one piece of the puzzle when it comes to improving CML survival rates. In lower-income countries, cancers are often diagnosed late, when treatment is less effective.