Innovation in pharma
Does fast-track drugs approval in EU run too fast?
More than two years after its launch, the EU's fast-track approval process for marketing new drugs, called PRIME, is broadly welcomed by patients and industry, walking the fine line between patients' safety and expediency, and between the need to foster innovation and remaining abuse-proof.
EU generics industry slams US ‘intervention’ in SPC manufacturing waiver talks
The EU generics industry has accused the US government of intervening in the ongoing discussion in the EU on the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver.
MEP: Need for an EU-wide cancer plan to ensure long-term pharma innovation
The creation of an EU cancer plan will improve EU citizens’ medical needs and access but will also simultaneously help bring innovations to the market, through enhanced collaboration among stakeholders, according to Belgian MEP Lieve Wierinck.
New drugs: how much are governments paying for innovation?
The European healthcare sector is divided over the “actual value” EU governments pay for the authorised and partly public-funded novel drugs, compared to medicines already on the market.
Estonia and Finland first to start exchanging healthcare data by end of year
Estonia and Finland will start exchanging digital prescriptions at the end of the year, in a groundbreaking move that Estonian Health Minister Riina Sikkut said she hoped other EU countries will follow.
Europe’s health sector worried about post-Brexit investment dearth
Fragmented, multilingual and over-regulated: Europe is currently not an attractive place for investors and things could get worse after Brexit, experts from the life sciences industry have warned.
‘Vital’ UK remains part of EU clinical trials, say MPs
Continued participation in EU-wide clinical trials and the Horizon 2020 research programme is ‘vital’ to the UK’s life sciences sector, according to a new cross-party report by UK MPs.
EU and UK patients with rare diseases in Brexit limbo
It is still unclear whether the UK will participate after Brexit in the European Reference Networks, which aim to help patients with rare diseases, potentially putting at risk millions of patients.
Health care risks being forgotten in Brexit talks, industry warns
Health risks being forgotten in Brexit negotiations, potentially delaying the availability of new medicines and imposing large costs on manufacturers, public health leaders have warned.
EU unveils health technology bill
The European Commission unveiled plans for a pan-EU Health Technology Assessment (HTA) law on Wednesday (31 January), with EU health chief Vytenis Andriukaitis promising that they would help patients take advantage of “an exciting era for innovation in health".
Fake medicines? Face 15 year jail term
Twenty-one EU countries have made falsifying medicines a criminal offence, carrying a potential jail sentence of 15 years, according to a new report published on Friday (26 January) by the European Commission.
Commission reforms meet with national ‘silence’, says frustrated EU health chief
EU governments are meeting the Commission's proposals to reform health systems with "silence", an exasperated Health Commissioner Vytenis Andriukaitis said on Thursday (25 January), pleading for more investment in prevention across the bloc.
Health tech bill to kick off busy policy agenda in 2018
The European Commission will propose a new law on Health Technology Assessments to kick off a busy EU health agenda in 2018.
Stakeholders call for more transparent meetings between pharma and EMA
Public health organisations and EU lawmakers say the closed-door meetings before the submission of a new drug between the pharma industry and the European Medicines Agency (EMA), a key player in the continent’s healthcare industry, should be more transparent.
Commission reassures ‘worried’ member states on Health Technology Assessment
The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical parts, a European Commission spokesperson told EURACTIV.com.
Drug pricing debate to take place in heated atmosphere
Following a Greek government request, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) will discuss on Friday (8 December) a recent dispute between Athens and ROCHE, a Swiss multinational company, over the latter’s decision to withdraw a cancer drug from the market.
UK and pharma industry call for transition period for medicines supply
With Brexit barely 15 months away, the UK government, as well as the European and British life science industry, is calling for a transition period on the regulation and supply of medicines in order to avoid potential disruptions in the market that will negatively affect patients.
Athens brings its dispute with pharma industry to the EU Council
The next EU Health Council on 8 December will discuss the “lack of drug availability in Greece”, amid mounting tensions between the leftist government in Athens and the pharmaceutical companies.
Andriukaitis: National health systems need ‘fundamental reform’
EU countries could save money and lives by increasing investment in disease prevention and health promotion, the European Commission said on Thursday (23 November), stressing that good health policy requires political will across all sectors.
Pharmaceutical company gives free access to drug after clash with Greek government
Following a clash with the Greek government over its decision to withdraw a cancer drug from the market, ROCHE, a Swiss multinational company, ultimately decided to make the drug available to patients for free.
Greek health minister fumes at pharmaceutical company after drug withdrawal
The Greek ministry of health reacted strongly to the decision of a pharmaceutical company to withdraw a drug from the market for “viability” reasons, saying it will not accept any blackmail.
Pharmaceutical company withdraws oncology drug from Greek market
A multinational pharmaceutical company has decided to withdraw an innovative oncology medicine from the Greek market, claiming that its price has fallen more than 50% because of the government’s regulatory interventions in the pharma area, EURACTIV.com has learnt.
Greek government on collision course with pharmaceutical companies over innovative drugs
Several pharmaceutical companies in Greece have threatened to stop supplying the market with innovative drugs and said they could even withdraw existing drugs as a result of an obligatory “discount” imposed by the Greek government and applied retroactively.