The European framework for intellectual property rights for biological medicines

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

Sex and grooming as exchange commodities in female bonobos’ daily biological market

The Biological Market Theory (BMT) posits that cooperation between non-human animals can be seen as a mutually beneficial exchange of commodities similarly to what observed in human economic markets. Positive social interactions are commodities in non-human animals, and mutual exchanges fulfilling the criteria of the BMT have been shown in several species. However, the study of biological markets suffers from methodological limitations that are mainly linked to the difficulty of clearly identifying the currencies and their exchanges in the short-term. Here, we test whether bonobo females are more attractive during their maximum swelling phase, whether they exchange grooming and Genito-Genital Rubbing (GGR) on a daily level of analysis, and whether these daily exchanges fulfil the BMT criteria. Females engaged more in GGR when their sexual swelling was in the maximum phase. Moreover, they exchanged grooming and sex according to the daily “market fluctuations” associated with swelling status. Females in the minimum phase (low-value) increased their probability to engage in GGR with females in the maximum phase (high-value) by grooming them preferentially. In line with the supply/demand law, the female grooming strategy varied depending on the daily number of swollen females present: the higher the number of swollen females, the lower the individual grooming preference. As a whole, our study confirms BMT as a valid model to explain daily commodity exchanges as a function of the temporary value of traders, and underlines the importance of a day-by-day approach to unveil the presence of a biological market when the value of traders frequently changes.

Walrasian equilibrium behavior in nature

The interaction between land plants and mycorrhizal fungi (MF) forms perhaps the world’s most prevalent biological market. Most plants participate in such markets, in which MF collect nutrients from the soil and trade them with host plants in exchange for carbon. In a recent study, M. D. Whiteside et al. [Curr. Biol. 29, 2043–2050.e8 (2019)] conducted experiments that allowed them to quantify the behavior of arbuscular MF when trading phosphorus with their host roots. Their experimental techniques enabled the researchers to infer the quantities traded under multiple scenarios involving different amounts of phosphorus resources initially held by different MF patches. We use these observations to confirm a revealed preference hypothesis, which characterizes behavior in Walrasian equilibrium, a centerpiece of general economic equilibrium theory.

The Off-Patent Biological Market in Belgium: Is the Health System Creating a Hurdle to Fair Market Competition?

We investigated the off-patent biological market in Belgium from a policy maker’s perspective, in light of the Belgian pharmaceutical health system. The main barriers relate to a short-term budgetary focus, to the overwhelming innovator’s reach and to a concertation model with assessment and appraisal being mixed which results in poorly effective policy measures.

The psychology of partner choice

Partner choice captures the idea that individuals exist in a biological market of potential partners, and we can therefore choose or reject our social partners. While prior work has principally explored the functional basis of partner choice, here we focus on its mechanistic basis, motivated by a surge of recent work exploring the psychology underlying partner choice decisions. This work demonstrates that partner choice is predictably sensitive to a number of factors, including 1) a potential partner’s generosity and fairness, 2) cooperative disposition, 3) moral decision-making, and 4) intentions. We then broaden our scope, first reviewing work suggesting that, in some cases, the psychology underlying partner choice may be distinct from other responses to a partner’s behavior. We then discuss work demonstrating the sensitivity of partner choice decisions to market characteristics as well as work that illuminates the neural, ontogenetic and phylogenetic basis of partner choice. We conclude by highlighting outstanding questions and suggest directions for future research.

Biological market effects predict cleaner fish strategic sophistication

Market-like situations emerge in nature when trading partners exchange goods and services. However, how partner choice option contributes to the expression of social strategic sophistication (i.e., the ability to adjust behavior flexibly given the specifics of a situation) is still poorly understood. A suitable study system to explore this question is the “cleaner” fish Labroides dimidiatus. Cleaners trade parasite removal in exchange for food with a variety of “client” species. Previous research documented strong interindividual variation in two features of their strategic sophistication, namely, the ability to adjust service quality to the presence of an audience and to give priority to clients with access to alternative cleaners (“visitor clients”) over clients lacking such choice options (“resident clients”). Here, we sampled various demes (i.e., group of individuals) of the same population of cleaner fish in order to investigate the extent to which factors describing fish densities and cleaning interaction patterns predict the strategic sophistication in two laboratory experiments. These experiments tested whether cleaners could increase their food intake through reputation management and/or learning to provide service priority to a visitor-like ephemeral food plate. We found that high “outbidding competition,” characterized by high densities of cleaners and visitor clients, along with visitor’s behavior promoting such competition, consistently predicted high strategic sophistication in cleaners. A better understanding of the role of learning versus potential genetic factors, interacting with local market conditions to affect strategic sophistication, is needed to clarify how natural selection has promoted the evolution and maintenance of cooperation in this cleaning mutualism.

Leadership and prestige, mothering, sexual selection, and encephalization: The computational services model

Long before the term Machiavellian Intelligence was coined, James Neel, a prominent geneticist, was pondering the role of 'princes' in the evolution of exceptional human intelligence. Neel discovered that in small-scale societies resembling those in which humans evolved, leaders had more wives and more children than other men. If this pattern, which is now well-established in the ethnographic record, characterized ancestral human societies, whatever traits predisposed men to become leaders would have experienced strong sexual selection. Neel proposed that the key trait was intelligence. Sexual selection on intelligent leaders therefore helped explain human encephalization. Many subsequent theories have attempted to explain why knowledgeable, skilled, and intelligent individuals are chosen as leaders or as mates. None, however, has adequately explained why they are chosen as both. We aim to fill this gap by operationalizing leaders as individuals who regularly make decisions that benefit most members of the group. Because human nuclear families comprise two unrelated individuals who cooperate for twenty years or more to raise their joint offspring, and because families are nested within subsistence groups, which, in turn, are nested within larger security and political groups, good decision-making skills provided large benefits to mates and families, as well as to members of one's subsistence group or larger security and political groups. We further argue that decision-making that benefits others as well as oneself can be especially computationally complex, and therefore that sexual selection and biological market forces favoring these skills favored increased brain size. Finally, because parents must make decisions for their cognitively immature offspring, decision-making that benefits others and other leadership abilities might have initially undergone strong selection in mothers, who provide most of the childcare in natural fertility populations. Decision-making that benefits others is one valuable example of what we term a computational service. Other important examples include threat and opportunity detection, gossip and information sharing, cultural transmission, story telling, medicinal knowledge, and advice and counsel. Providing computational services in exchange for a variety of benefits would have helped subsidize a large, energetically expensive brain. Individuals who provided particularly valuable services gained prestige, i.e., additional benefits from fellow group members.