The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether JCA results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as ‘national HTA’ and which requirements need to be fulfilled to trigger the obligations under Article 13 HTAR are discussed in more detail in this paper.
ATMPs are the most expensive innovative treatments, thus they require special regulation. Past regulatory measures in France, such as limiting the growth of drug expenditures, the creation of a fund to finance pharmaceutical innovation, the use of performance-based contracts and greater emphasis on medico-economic evaluations in pricing have been contributing to having both universal access to innovative therapies and fair remuneration for innovation. The importance of transparency, public participation in healthcare evaluation, and the challenges of setting drug prices based on their value are not negligible either. Although further negotiations are still necessary to ensure equitable access to medicines and control rising healthcare costs, France has made pioneering steps recently which would be worthy to follow for other states. The Social Security Financing Act for 2023 introduces measures to control face prices, offers a new funding model, and encourages manufacturers to submit reimbursement claims for the full scope of marketing authorizations.
Climate change profoundly impacts all aspects of human life, including health. International fora and nation States recognise the importance of urgently cutting greenhouse gas emissions as a primary cause of global warming. States' commitment to alter climate change has resulted in several treaty documents referring explicitly to human rights obligations. But what exactly are States' obligations under climate change treaty law and other human rights treaties? And what is the judiciary's role when confronted with the right to health violations and systemic deficiencies relating to climate change? Can climate change litigation give individual citizens a remedy to right to health violations and reduce the impact of climate change?
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：