From lab to mass production: a policy for enabling the licensing of mRNA vaccines.

Using the South African vaccine technology transfer hub supported by the WHO as an example, we show that the know-how needed to move mRNA vaccines from prototype to mass-production acts as an invisible barrier to market entry of mRNA vaccines. Overcoming this barrier relies on scarce human capital. In view of this scarcity and in preparation for the next pandemic, we propose broadening the scope of an existing WHO program, the WHO Academy, so that it coordinates knowledge diffusion initiatives by forming a systematized repository of know-how and a register of experts. As we explain, this proposal has an advantage in overcoming barriers to entry over current approaches of know-how acquisition.

Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies.

This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required.

Prospect patents and CRISPR; rivalry and ethical licensing in a semi-commons environment.

The prospect theory of patents views patents as a tool for the development and commercialization of inventions. Prospect patents rely on broad control of technology so that rivalry between competing products is diminished thus avoiding waste of common-pool resources. The theory has been widely criticized but in this article we argue that it does not address the realities of an economy where many innovations are created by universities. Although university patents on inventions such as new gene-editing tools fit squarely in the definition of prospect patents, they may still allow rivalry to resurface at the commercialization stage. This rivalry is not between competing firms; it is between competing visions of the prospect: 'the university's vision versus the licensees.' We use as a case study the CRISPR-Cas9 technology invented by universities and commercialized by licensees. We employ patent landscape analysis showing that CRISPR-Cas9's prospects comply with the characteristics of prospect patents and, above all, diminish rivalry at the commercialization stage. As the lack of competition leads to excessive treatment prices, tensions arise because the licensee understands CRISPR-Cas9 as a revenue-generating prospect, whereas the university views it as a technology requiring broad distribution. Such discerning visions can breed rivalry between licensor and licensee despite broad patent rights. In addressing this we turn to the literature on semi-commons, which implies an environment where private rights of exclusion such as prospect patents work with ethical licenses and a domain of resources open for reuse to foster innovation. We argue that in this environment, universities can emerge as important actors in the regulatory enterprise through additional ex post licensing. To this end, we propose a market-based solution in the form of a license allowing for patent re-licensing if the licensee fails to address a predefined demand for the final product.

Remote digital monitoring of medication intake: methodological, medical, ethical and legal reflections.

In 2017, regulatory approval was given in the US for a 'digital pill', a pill for which actual ingestion could be remotely monitored. The pill, Abilify Mycite is marketed by Otsuka but the monitoring system derives from Proteus Digital Health. In this paper, we focus on this digital pill and another equivalent system from AiCure which relies on facial recognition. Both systems not only remind the patient to take a pill but also verify the actual intake. In this process, patient-related data beyond the fact that the pill has been taken are also collected and sent to a remote computer system of the system-providing company and possibly to third parties.Although marketed as 'innovative', the introduction of such systems raises questions as to the limitation of patient autonomy, secondary uses of patient data, impact on the physician's liability, and artificial inflation of drug prices. Whereas incorrect medication taking can be problematic, it can be questioned whether remote intake-monitoring systems are, from an ethical, legal and social perspective, the ideal way to address this. In this paper, we will reflect on this question from the position of the different potential stakeholders involved.