Public health systems face the contradiction of skyrocketing cancer incidence and cancer drug prices, thus limiting patient access to more effective treatments. The situation is particularly dire in low- and middle-income countries. We urgently need consensus on the main determinants of this problem, as well as specific, effective and feasible solutions.

Analysis of available data reveals that the problem has reached its current magnitude only recently and is not related to the growing complexity of drug production technology, but rather to corporate profits and the failure of market mechanisms to allocate resources based on health needs.

Despite the obstacles, there is ample room for effective intervention: joint price negotiations, cost transparency, greater support for creation of manufacturing capacity, and regulatory measures that facilitate introduction of generic and biosimilar drugs and reduce intellectual property barriers to better use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights.

Such actions will not be effective if there is no consensus around them, or if low- and middle-income countries act in isolation. This is precisely where international organizations must intervene.

KEYWORDS Public health, price, cancer drugs, inequality, less-developed countries, developing countries, Cuba

Biotechnology has changed the pharmacopeia. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Yet, treatments based on effective, costly biopharmaceuticals for prolonged use hamper the goals of ensuring universal therapeutic coverage and access to the best treatments. This conflict surfaced 30 years ago with synthetic drugs, and the solution was to create generics once the developers’ patents expired. Biosimilars are not generics, strictly speaking, as it is impossible to guarantee that they are molecularly identical to the original product; nor are they completely new products, as they rely on a great deal of prior work done by other scientists. National strategies are needed to ensure the broadest possible coverage in the best interests of the population. The key to a strategy to ensure access to the best treatment available lies in the concept of “totality of evidence,” which includes all information about a given molecular structure and its mechanism of action; safety and efficacy information from the first clinical trials; and monitoring data from products’ use in medical practice. A strategy of broad biological and molecular categorization plus intense pharmacovigilance would reduce development costs, the main barrier to widespread access.

KEYWORDS Biosimilar pharmaceuticals, biosimilars, biologics, legislation, social control, health services accessibility, health services needs and demand, Cuba