Biotech Act - Vital Signs

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Biotech Act

A collection of 23 posts

EMA sets out process to appoint next Executive Director

EMA sets out process to appoint next Executive Director

EMA’s September Management Board meeting advanced the process for appointing its next Executive Director while reviewing preparations for new EU pharmaceutical legislation

EU tobacco overhaul ‘very well advanced’ as Brussels targets vapes and heated tobacco

Tobacco Products Directive

EU tobacco overhaul ‘very well advanced’ as Brussels targets vapes and heated tobacco

Health ministers met for an informal Council meeting in Dublin, with tobacco reform, the Biotech Act and medical devices topping the agenda

MEPs seek to boost biosimilars in pharma protection deal

MEPs seek to boost biosimilars in pharma protection deal

EU Legal Affairs Committee support compromise offering drugmakers longer protection in return for European investment, while clearing the way for faster biosimilar competition

Spain pushes EU to use its purchasing power on innovative medicines

Spain pushes EU to use its purchasing power on innovative medicines

Spain wants the EU to use its collective demand for innovative medicines to strengthen negotiating leverage and attract biotech investment and manufacturing

Inside EU Health: Spain to propose alternative to SPC; clinical trials transparency; AI

Inside EU Health

Inside EU Health: Spain to propose alternative to SPC; clinical trials transparency; AI

Spain to propose early procurement as an alternative to SPC Extension; European health NGOs push for full publication of clinical trial results; WHO/Europe urges faster development of AI governance

MEPs supportive of draft Biotech report, but divisions over incentives remain

MEPs supportive of draft Biotech report, but divisions over incentives remain

The European Parliament's first debate on its draft Biotech Act report showed broad political support for strengthening Europe's biotechnology sector, while exposing disagreements over how best to boost innovation, streamline clinical trials and incentivise investment. Presenting their joint report, co-rapporteurs Wouter Beke MEP (EPP, Belgium)

Inside EU Health: MFN; wastewater treatment; medical devices; social media

Inside EU Health

Inside EU Health: MFN; wastewater treatment; medical devices; social media

Implications of MFN note before summer; Várhelyi reassures ministers on Urban Wastewater Treatment implementation; on medical devices divisions persist over governance; special panel on online child safety will present its final report on 13 July

EU health ministers may demand further review of Urban Wastewater rules

EU health ministers may demand further review of Urban Wastewater rules

Tomorrow, health ministers will discuss an agreed position on the European Biotech Act I directive, but the real discussions may lie elsewhere

Inside EU Health: Co-ordinated pricing and reimbursement; Biotech Act SPC; COVID-19 contracts

Inside EU Health

Inside EU Health: Co-ordinated pricing and reimbursement; Biotech Act SPC; COVID-19 contracts

Beneluxa Initiative calls for pricing and reimbursement coordination; EFPIA argues that the Biotech Act 12-month extension to SPC is too narrow ; AG recommends dismissing Commission appeal on COVID-19 contract access

Inside EU Health: Ireland’s health priorities; pharmacies and preparedness

Inside EU Health

Inside EU Health: Ireland’s health priorities; pharmacies and preparedness

Ireland’s Presidency of the EU will link health and competitiveness; PGEU outlines the vital role of community pharmacies in preparedness

Ireland’s Presidency of the EU will link health and competitiveness

Irish Presidency

Ireland’s Presidency of the EU will link health and competitiveness

Regulatory reform will headline Ireland's EU Presidency agenda, with the Biotech Act and medical devices overhaul leading negotiations

Inside EU Health: Biotech Act; EU budget; patient organisations

Inside EU Health

Inside EU Health: Biotech Act; EU budget; patient organisations

ENVI committee raises doubts over Biotech Act SPC extension; 490 health experts urge EU to ring-rence €10 billion for health in EU budget; barometer on the involvement of patient organisations

ENVI opinion signals early resistance to Biotech Act SPC extension

ENVI opinion signals early resistance to Biotech Act SPC extension

The European Parliament's Environment, Climate and Food Safety Committee (ENVI) has delivered the first parliamentary opinion on the European Commission's proposed Biotech Act

Commission estimates the cost of Biotech Act protections at €210 million per year

Commission estimates the cost of Biotech Act protections at €210 million per year

A Commission Staff Working Document supporting the Biotech Act I presented in December shows that the estimated cost of an extension to supplementary protection certificates could exceed €210 million per year

Inside EU Health: Ebola update; nicotine pouches; biosecurity; WHA; hantavirus

Inside EU Health

Inside EU Health: Ebola update; nicotine pouches; biosecurity; WHA; hantavirus

Ebola declared emergency of international concern; WHO warns nicotine pouches risk hooking a new generation; EuropaBio ups efforts on biosecurity; World Health Assembly kicks off; EU activates crisis response mechanism to monitor hantavirus outbreak

EU’s Health Package is Europe’s answer to Trump’s drug pricing policy, says Várhelyi

Cypriot presidency

EU’s Health Package is Europe’s answer to Trump’s drug pricing policy, says Várhelyi

Várhelyi estimated reforms could lower business costs by 20-25 percent - potentially offsetting the impact of US tariffs and "MFN" pricing.

Inside EU Health: Europe invests in 10-year preparedness research plan; Biotech Act I rapporteurs; EU and Canada health agencies joint plan; HTA report

Inside EU Health

Inside EU Health: Europe invests in 10-year preparedness research plan; Biotech Act I rapporteurs; EU and Canada health agencies joint plan; HTA report

Europe invests €240 million ten-year pandemic preparedness research; Biotech Act I rapporteurs confirmed; EU and Canada health agencies deepen ties; HTA annual report on first year of implementation

Inside EU Health: WHO defends itself from US slurs; pilot targets 70-day clinical trial approvals; less than 1% of research spent on key women’s health issues

Inside EU Health

Inside EU Health: WHO defends itself from US slurs; pilot targets 70-day clinical trial approvals; less than 1% of research spent on key women’s health issues

WHO defends itself against US accusations; FAST-EU pilot targets 70-day clinical trial approvals; less than 1% of research funding goes to key women’s health conditions

Inside EU Health: Biotech Act; targeted fix of medical devices; ‘Safe Hearts Plan’ arrives

Inside EU Health

Inside EU Health: Biotech Act; targeted fix of medical devices; ‘Safe Hearts Plan’ arrives

🎄Happy Christmas! The Health Package has arrived: Biotech Act, Targeted fix of medical device and; ‘Safe Hearts Plan’

Europe pushes to regain ground on competitors with new Biotech Act

Europe pushes to regain ground on competitors with new Biotech Act

With the publication of the Biotech Act, the EU sets out how it intends to boost the sector’s competitive position in the face of China’s rapid rise

Inside EU Health: Biotech Act(s); WHO preparedness; and study on drug spending dynamics

Inside EU Health

Inside EU Health: Biotech Act(s); WHO preparedness; and study on drug spending dynamics

Biotech Act(s); WHO preparedness; EMA consults on primates in research; and IQVIA study on drug spending dynamics

Commission takes a two step approach to Biotech Act

Commission takes a two step approach to Biotech Act

Commission presses ahead with health-focused Biotech Act I' in 2025, with a broader framework to follow in 2026

Várhelyi sets out his sweeping plans to reshape Europe’s competitiveness in health

Competitiveness

Várhelyi sets out his sweeping plans to reshape Europe’s competitiveness in health

EU Health Commissioner Várhelyi has many ambitious plans and a tight schedule