Europe’s new Health Technology Assessment Regulation (HTAR) on the horizon

 In early 2025, Europe will implement a uniform, pan-EU framework under the new Health Technology Assessment Regulation (HTAR), addressing disparities in evaluating the clinical value of pharmaceuticals and medical devices.

The HTAR introduces a Joint Clinical Assessment (JCA) across the continent, a framework mandating that all 27 Member States adopt standardised procedures for evaluating the clinical evidence of newly submitted products or devices.

This special report looks at the opportunities, concerns, stakeholders’ readiness and ongoing administrative complexities. (...)

After Belgium, France seeks Commission’s green light to ban disposable e-cigarettes

 

The French, parliament reached an agreement on Thursday (21 March) to ban so-called ‘puffs’, single-use electronic cigarettes. The prohibition will be expected to come into force, at the end of September, according to Green MP Francesca Pasquini, who initiated the law. 

The text was widely adopted by the National Assembly in December and then ratified by the French Senate in February. The final stage was to convene a joint committee, bringing together members of parliament from both chambers. The committee reached a joint text without difficulty.

The French future bill now needs the green light from the EU Commission. I am “immediately asking the European Commission to confirm France’s decision. The fight against smoking must continue,” said Health Minister Catherine Vautrin on X.

The European Commission has six months to approve the legislation. Pasquini is quite optimistic since the Commission gave their go-ahead, for a ban on “puffs” in Belgium on Tuesday (19 March). (...)

Sweden makes naloxone spray an OTC product, to prevent opioid overdose deaths

 Naloxone nasal spray, which can save opioid users from overdoses, will soon be available without prescription in Sweden. The move seeks to increase early interventions outside healthcare settings, marking a major shift in Swedish drug policy.

Sweden will join France and the UK in making a naloxone nasal spray available to individuals over the counter. The drug has been used in American and European healthcare for more than 50 years as a potent opioid antagonist drug, that rapidly reverses the effects of opioid-based drugs.

“The opioid reversal drug naloxone saves lives, but its availability in Sweden has been too low. I am pleased to announce today that it will soon be sold over the counter in Swedish pharmacies. This will save lives,” said the Social Affairs Minister and Christian Democrat, Jakob Forssmed.

The announcement came after the Swedish Medical Products Agency decided on 19 March 19 to allow the over-the-counter sale of Respinal, a naloxone nasal spray made by the Norwegian company DNE Pharma. (...)

Vending machines to ‘stand in’ for small town Bulgarian pharmacies

 

Pharmacy owners would be able to register vending machines for over-the-counter medicines to be placed in towns and villages in Bulgaria where no pharmacies are available, the Ministry of Health told Euractiv.

Nearly 10% of Bulgarian municipalities do not have a single pharmacy on their territory, and many cities with a population of up to 50,000 people do not have a 24-hour pharmacy, further complicating access to medicines.

According to the health ministry, the latest amendments to the Medicinal Products in Human Medicine Act will solve part of this problem, as they will allow vending machines outside pharmacies to sell medicines that do not need a doctor’s prescription. (...)

Portugal desperdiçou 790 milhões de euros em linhas de crédito

 

Dos 890 milhões de euros que Portugal tinha à disposição desde 2018, a quase totalidade ficou por utilizar. Banco Europeu de Investimento decidiu cancelar linhas de crédito on-lending, apurou o ECO.

A maior parte das linhas de crédito que o Banco de Fomento herdou da IFD foram canceladas e Portugal terá desperdiçado cerca de 790 milhões de euros de financiamento, apurou o ECO.

O Banco Europeu de Investimento (BEI) decidiu atribuir à Instituição Financeira de Desenvolvimento (IFD) – uma das entidades que foi integrada na Sociedade de Garantia Mútua para dar origem ao Banco Português de Fomento – um empréstimo de 100 milhões de euros, no âmbito de uma linha de crédito de 250 milhões de euros. Ler mais

Rádio Valor Local, Contas Consigo

 

Contas Consigo com André Antunes – Os Escalões do IRS (...)

Máfias cobram a imigrantes por agendamentos na agência que substituiu o SEF

 

Imigrantes desesperados pela obtenção ou renovação da licença de residência compram agendamentos para acesso à AIMA a grupos mafiosos que, para impedir os interessados de o fazerem diretamente, sobrecarregam as linhas telefónicas da agência. Há queixas na Polícia Judiciária. 

Apenas por telefone é possível agendar um contacto personalizado com a Agência para a Integração, Migrações e Asilo  (AIMA), substituta do ex-Serviço de Estrangeiros e Fronteiras (SEF). Mas as linhas telefónicas permanentemente saturadas impedem os imigrantes, desesperados por um título de residência, ou pela renovação do mesmo, de lograrem, por si mesmos, marcar o acesso presencial à agência. Contudo, via redes sociais, vão recebendo propostas de venda de agendamentos rápidos oriundas de indivíduos ou de grupos organizados, a troco de avultadas quantias. Vários advogados já apresentaram queixa na Polícia Judiciária (PJ). Ao que o NOVO apurou, por trás da sobrecarga das linhas telefónicas estão grupos mafiosos que, recorrendo a plataformas digitais avançadas, dificultam o acesso a quem utiliza um telefone normal para se apoderarem, eles próprios, das chamadas atendidas pela AIMA, fornecendo para agendamento os dados dos clientes a quem prestam serviços. Ler mais