Social pharmaceutical innovation and alternative forms of research, development and deployment for drugs for rare diseases.

Rare diseases are associated with difficulties in addressing unmet medical needs, lack of access to treatment, high prices, evidentiary mismatch, equity, etc. While challenges facing the development of drugs for rare diseases are experienced differently globally (i.e.

The Promises of Speeding Up: Changes in Requirements for Animal Studies and Alternatives during COVID-19 Vaccine Approval-A Case Study.

On 21 December 2020, the European Commission granted conditional marketing authorisation for the BNT162b2 COVID-19 vaccine 'Comirnaty', produced by Pfizer/BioNTech. This happened only twelve months after scientists first identified SARS-CoV-2. This stands in stark contrast with the usual ten years needed for vaccine development and approval.

Implementing pharmaceutical track-and-trace systems: a realist review.

Introduction: One way to prevent falsified medical products from entering the regulated pharmaceutical supply chain is to implement a pharmaceutical track-and-trace system (PTTS). Such systems in the most extensive versions generally mandate a scan at every point of contact with the medical product: from the point of entry to dispensation. There have been several attempts to implement such systems; for example, a 'full' PTTS in Turkey and the more pared-down version offered by the European Union's Falsified Medicines Directive and Delegated Act.

Necessity under construction - societal weighing rationality in the appraisal of health care technologies.

Health care coverage decisions may employ many different considerations, which are brought together across two phases. The assessment phase examines the available scientific evidence, such as the cost-effectiveness, of the technology. The appraisal then contextualises this evidence to arrive at an (advised) coverage decision, but little is known about how this is done.

Around the Tables - Contextual Factors in Healthcare Coverage Decisions Across Western Europe.

Background: Across Western Europe, procedures and formalised criteria for taking decisions on the coverage (inclusion in the benefits basket or equivalent) of healthcare technologies vary substantially. In the decision documents, which display the justification of, the rationale for, these decisions, national healthcare institutes may employ 'contextual factors,' defined here as considerations. Little is known about how the use of such contextual factors compares across countries.

The bare necessities? A realist review of necessity argumentations used in health care coverage decisions.

Context: Policy makers and insurance companies decide on coverage of care by both calculating (cost-) effectiveness and assessing the necessity of coverage.

Aim: To investigate argumentations pertaining to necessity used in coverage decisions made by policy makers and insurance companies, as well as those argumentations used by patients, authors, the public and the media.

Methods: This study is designed as a realist review, adhering to the RAMESES quality standards.