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.
The panelist will focus on the distinction between ethics, law and on requirements towards building progressive alternatives from the legal perspective. It will also examine the impact legislative and regulatory framework and jurisprudence have on the enjoyment of the right of health during COVID-19. During the pandemic many national frameworks used emergency law in order to introduce containment and mitigation measures into society. Most of these were enacted as emergency legislation, and this poses certain additional challenges in terms of the rule of law, given the often limited impact assessment or the absence of judicial review. These key characteristics that carry an element which can only be deemed appropriate given temporal limitations. From divergent national responses to combat COVID-19 to broader multilateral agreements on global health security, inequities have come to the fore. Assessing the proportionality of measures adopted to achieve legal aims necessitates an interdisciplinary and cross-sectoral collaboration and examination, as well as embedding mechanisms to systematically monitor broader implications for global health, and societal cohesion and resilience. Law is a part of interdisciplinary collaboration needed to achieve efficient commitments in order to combat the COVID-19 pandemic effectively. Even though law itself is not a panacea, remedying broader societal inequities, it is an essential step needed towards implementation of effective health policies into society. Indicative examples on aspects of interest and steps taken by payers to ensure equitable access for all will be elaborated upon. An overview on the implications of dynamics between developed and developing countries will also be presented, with due emphasis on the future of both European and global health and partnerships for accessibility and accountability.
Examining the health technology assessment (HTA) landscape in Europe and globally, the limited involvement of HTA bodies in vaccine assessment becomes evident. To a large extent this is because of the role the National Immunization Technical Advisory Groups in providing recommendations for vaccines and immunisation. The role of patients and citizens, given the fact they are important stakeholders in HTA, is well acknowledged, but their involvement remains limited. Issues on how vaccines are developed, including the lack of patient-reported outcomes (PROs) in vaccine research and development, prevent the clearer benefit/risk information to reduce uncertainty. Given the fast-paced approach in comparison to traditional trials and the high level of uncertainty for different population groups, a comprehensive risk communication strategy, is key both for evidence-informed deliberative processes, as well as to ensure the success of vaccination programmes with the best possible outcomes and to overcome vaccine hesitancy. The impact of vaccination or non vaccination extends to families, communities and also has potential psychological consequences of alternative non-vaccine interventions such as lockdowns. Inclusion of such broader impacts may alter both acceptance and willingness-to-pay thresholds for COVID-19 vaccines. Given the lack of a specific legal framework to allow interaction between patients and other stakeholders at both institutional and individual levels, with respect to GDPR, it is vital to ensure interaction and engagement. In a democratic society, it is also important to assure general engagement that will be inclusive and transparent, without exclusion of vulnerable societal groups, that can only be assured by means of communication of scientific advice and regulatory decisions in a language accessible to all, with readily understood terms.
This study will describe the current legal and regulatory frameworks implemented during the different phases of the COVID-19 pandemic, assessing how well they worked. It will offer insights regarding coverage and reimbursement for specific health and social care services for people having suffered severe injuries in the context of providing work under particular circumstances, often far removed from their regular working space. Working environments and spaces, as well as overall working conditions, have been radically changed in a sudden and unexpected way. Jobs have been placed at risk, with many disproportionally affected by the lack of supporting mechanisms. New working routines have impacted the lives of many, altering not only working, but also disrupting living patterns. There is a strong emerging need to adapt the legal and regulatory framework related to health and social care services provision, in terms of prevention but also in relation to coverage and reimbursement. New injury patterns and new forms of injury, incl. in relation to mental health, have arisen. They are coupled with burden-of-proof challenges and the need to rebalance social rights. Unprecedented legal and regulatory measures were required to mitigate the social and economic effects of this global health emergency on businesses, workers and citizens. In this context of limitation of individual rights and social freedoms, questions of implementation of EU and international conventions arose (TFEU, ECHR, ILO), while legal and regulatory measures had to be enacted in order to create effective framework for pricing and reimbursement of the specific injuries, during emerging circumstances. Balancing sustainability, burden-of-proof issues and social rights through a comprehensive methodological framework can help resolve ambiguities that often leaded to litigation and, at the same time, resolve the issues of proportionality and legitimate aim in terms of the adopted regulations.
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