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Study highlights EU’s fragmented access to new medicine – Euractiv

Study highlights EU’s fragmented access to new medicine – Euractiv

Access to novel medicines continues to vary widely across EU member states. Though health remains mostly a national competence, a Euractiv cross-country report shows patients in each country face unequal challenges when accessing new therapies.

The W.A.I.T. (Waiting to Access Innovative Therapies) Indicator is a European study assessing the availability of innovative medicines and the time it takes for patients to access them. It measures the time from a medicine’s regulatory approval to being included on a country’s reimbursement list.

“This study highlights the disparity across European countries in the availability of novel medicines, from as little as four months to 2.5 years, showcasing the huge differences experienced by patients in neighbouring countries,” said Aurelio Arias, Director of EMEA Thought Leadership at IQVIA, which conducted the study on behalf of the European pharmaceutical association, EFPIA.

He told Euractiv: “The number of available medicines has also deteriorated from last year’s study, with a drop of 2% in the number of medicines and an increase of 3% in the median time to availability.”

“Although rare diseases saw an improvement in time to availability, oncology medicines continue to be impacted negatively, with an increase in delay of 6%, which adds to the wider issues experienced in screening and surgery in many countries,” Arias explained, adding that “the root causes are many but further investigation shows 71% of delays occur after a product has been filed for pricing and reimbursement.”

Sweden’s ‘orphan’ access

According to the 2024 EFPIA’s W.A.I.T. indicator, 15 orphan drugs out of 63 EU-approved products were made available in Sweden between 2019 and 2022. In comparison, the highest number was found in Germany, where 56 new orphan drugs were introduced, and the lowest number was in Lithuania, where only one new orphan drug was made available.

The time of availability for orphan drugs was 366 days, while for all new drugs, it took 299 days to reach Sweden.

Oskar Ahlberg, vice chairman of the Board of the Swedish Association of Rare Diseases, describes the Swedish results as particularly bad in a European context.

“Sweden does not compare so well with, for example, Germany, where the relevant authority reimburses all new medicines approved by the EU and appraises the drug’s effectiveness after one or two years. In Sweden, the corresponding agency waits a long time to see if an orphan drug is medically effective in relation to the cost,” he told Euractiv.

Czechia improves, but challenges persist

Over the past four years, Czechia has climbed from 20th to 7th place in the rankings for the availability of innovative medicines. According to the W.A.I.T. study, 104 newly approved innovative medicines are now on the market.

However, local innovative companies caution that this leap in the rankings does not necessarily translate to significantly better affordability of these drugs in the country.

“It should be remembered that these are medicines that have reached even a single patient,” explained David Kolář, Executive Director of the Czech Association of Innovative Pharmaceutical Industry (AIFP). He emphasised to Euractiv that if the WAIT report considered only those medicines systemically available to all Czech patients, only 18 products would be fully accessible.

“Many factors affect the actual availability of innovative medicines for patients in our country,” Kolář noted. “These include regional disparities in healthcare, limited capacity of specialised centres, time delays in treatment, and various restrictions on prescribing and using medicines.”

Nevertheless, AIFP welcomes Czech progress and adds that it is mainly due to the constructive cooperation of all stakeholders in Czechia – notably between the health ministry, regulator, pharmaceutical companies, experts, patient organisations and insurance companies.

Slovakia’s slow progress

Slovakia continues to struggle with access to innovative therapies. The availability rate stands at 17%, well below the 43% EU average. The country ranks 29th on the W.A.I.T. indicator in total availability of medicines over the past four years.

“We have no reservations regarding the Slovak data; they are accurate, and we agree with them,” Iveta Pálešová, Executive Director of the Slovak Association of Innovative Pharmaceutical Industry (AIFP), told Euractiv.

She noted that the W.A.I.T. indicator has been under development for several years to unify the methodology and make the data comparable between countries with different reimbursement systems, levels of patient entitlements to treatment, or reimbursement of treatment from public health insurance.

She added, though, that “despite the changes in our legislation, the number of medicines included in the categorisation has increased. Due to the innovation gap, medicines are being categorised in Slovakia that were registered before 2019. These are not entirely captured by the W.A.I.T. indicator.”

The Netherlands slowing down

“Unfortunately, the situation in the Netherlands is getting worse,” Dutch Association of Innovative Medicines (VIG) spokesperson Anton van Tuyl told Euractiv, highlighting that the wait time increased from 328 to 404 days last year, with some drugs even coming with two-year wait times.

“It is imperative that all parties involved come together to solve this problem,” van Tuyl said. He explained that VIG understands cost-consciousness in healthcare is important, but remains convinced that there are ways to curb spending without unnecessarily keeping patients in the waiting room. Van Tuyl suggested a more risk-oriented assessment as a possible way of leading to an acceleration.

Bulgaria’s bumpy progress

Bulgaria provides better access to innovative medicines compared to most countries in Central and Eastern Europe, the W.A.I.T. study reveals.

The European Medicines Agency has authorised 167 innovative medicines, of which 72 medicines (43%) are available to Bulgarian patients. The data shows that the country approved 17 new medicines in the period 2021-2022, which is significantly more than the countries in the region.

“Bulgaria is still seriously lagging behind most Western European countries. Bulgarian patients wait an average of two years for the National Health Insurance Fund to start paying for a new medicinal product. In many cases, whether the treatment is affordable, or not, determines whether, how long and how the patient will live,” Deyan Denev, Executive director of ARPharM Bulgaria, told Euractiv.

He explained that the delay in the approval of new drugs in Bulgaria comes from a procedure that requires the disease to be included in the State Health Fund (NHOF) list and only then can the new therapy be evaluated. In cases where the disease is already included in the list, the Bulgarian authorities delay the decision until the therapy is covered in a certain number of EU countries first.

“The new parliament should start immediately with the changes in the legislation on the introduction of the European regulation on joint clinical evaluations, and these obstacles will disappear,” said Denev.

[By Monica Kleja, Aneta Zachová, Filip Áč, Christoph Schwaiger, Krassen Nikolov, Vasiliki Angouridi, Edited by Brian Maguire | Euractiv’s Advocacy Lab ]

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