Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the frontline by proving the usefulness of this practise in favour of patients for an early access to treatment. Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) a virtual Repurposing Observatory Group (RepOG) was set up in 2019 to define and test the practical aspects of a pilot project thought to provide support to “not-for-profit” stakeholders generating or gathering data for a new therapeutic use for an authorised medicine. The group's initial plan was impacted by the outbreak of the SARS-CoV-2 pandemic and the launch of the pilot needed to be postponed. This article describes the progress and the activities conducted by the group during this past and yet extraordinary 2020–2021 to keep the project alive and explores on the background of this topic together with the obvious opportunities this health crisis has brought up in terms of repurposing of medicines.
In this article, we examine what the role of the private sector in times of crises is and whether the private sector is, and can be held to be, accountable. COVID-19 has amplified the difficulties with public–private partnerships and this article addresses several aspects concerning business enterprises, in particular transnational corporations, human rights and health sector activities, highlighting the key aspects to understand and address accountability issues. The article also explores accountability for the private sector, the processes to ensure accountability, and the relevance of regulation and self-regulation.
The first panellist will focus on the jurists view on the legislative proposal on DCC, discuss proportionality of measure, incl. key considerations for DCC and PLF data combinations. A basic overview on the differences between vaccination, certificates, immunity passports and other passes, and the key characteristics of the DCC will be provided. Feasibility in terms of implementing acts across EU Member-States will be elaborated upon, incl. both potential expiry and revocation, as well as potential remedies in case of emerging issues, i.e., right to DCC, but no vaccine, strong contraindication against vaccination, known issues of reduced immunity despite vaccination, etc.
Critical aspects with relevance for both the European and the global dimensions, i.e., GDPR and data transfer agreements, secondary use of health data, human-rights' issues, implications for vulnerable groups, etc., will also be discussed.
The fourth speaker will present the role of HTA in reimbursement, as well as existing pricing frameworks and HTA initiatives, and determining overall access. An overview of constraints and opportunities in terms of establishing legislative frameworks to enable deliberation, transparency will be further discussed. Their importance for national healthcare systems, i.e., payers, and for ensuring system sustainability. Affordability will be examined in terms of effect on individuals, on payers, and on systems.
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