Compulsory Licenses for Cancer Drugs: Does Circumventing Patent Rights Improve Access to Oncology Medications?

Abstract

Worldwide, there are enormous inequities in cancer control that cause poor outcomes among patients with cancer who live in low- and middle-income countries (LMICs). One of the biggest challenges that oncology faces today is how to increase patient access to expensive, but life-saving, therapies in LMICs. Access to cancer medications in LMICs is a major problem, especially in recent years, as the costs of these therapies continue to rise exponentially. One mechanism available to LMICs to improve access to cancer medications allows a country to pursue a compulsory license for a given drug. Here, we will review how the legal framework in the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights Agreement and the Doha Declaration supports countries to circumvent patent laws and acquire compulsory licenses for essential medicines. We will also discuss the current and future role of compulsory licenses in oncology and how compulsory licenses may improve access to cancer drugs in LMICs.

Enhancing global access to cancer medicines

“…It would also allow other cancer medicines to be considered for inclusion on the World Health Organization Model Lists of Essential Medicines. Table describes some methods to help reduce cancer medicine prices …”

“…Table 4 describes some methods to help reduce cancer medicine prices. 8,24,28,30,[42][43][44][45][46][47][48][49][50][51][52] Although a combination of these methods can continue to be used, recent publications suggest that further change is required. 28,30 Building on the work of others, we propose that an international body comprising representatives from the pricing authorities of all countries is convened.…”

Improving access to high‐cost cancer drugs in Latin America: Much to be done

“…98 On June 17, 2016, after months of unsuccessful negotiations with Novartis, the Colombian Minister of Health finally issued Resolution 2475, declaring that it would be in the public interest for the government of Colombia to control the price of imatinib by setting a price limit on the drug. 100,101 On the other hand, there have been cases in which the use of compulsory licenses led to pressure by the pharmaceutical industry, loss of investment, and trade frictions with the countries producing patented drugs. 99 The pharmaceutical industry claims, with little evidence, that not supporting copyrights in LMICs could have a negative impact on innovation because it may limit economic incentives, and that high prices granted by patents are indispensable for recouping investment in research and continuing investigation.…”

“…60 Indeed, various observational studies found that pharmaceutical companies whose products underwent compulsory licensing did not experience a decline in the rate of new drugs patented or in their innovation activity. 100,101 On the other hand, there have been cases in which the use of compulsory licenses led to pressure by the pharmaceutical industry, loss of investment, and trade frictions with the countries producing patented drugs. 98,102 In addition, compulsory licenses may raise efficacy and safety concerns of generics and biosimilars.…”

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

“…Recently the compulsory licencing has more often been presented as a viable solution for medicine access improvement (Favereau, 2017;Sanchez & Saout, 2017;Boulet, 2017;Maraninchi, 2016;Linthorst, 2016;Hoen, 2017;Hirschler, 2015;Bognar, Bychkovsky & Lopes jr, 2016 ) . Furthermore, some authors fi nd signifi cant the latest ruling of German Federal Supreme Court (raltegravir case 6 ), as a compulsory licence was granted in Germany for the fi rst time since the Second World War (Slowinski, 2018;Pacud, 2018;Hohne, 2019;Pitz, 2019).…”