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EU Split Over Extra Market Protection for Medicines as Biotech Act Talks Intensify

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EU health ministers remain divided over a proposal to extend market protection for certain innovative medicines, as Brussels seeks to balance industrial competitiveness with patient access and healthcare affordability.

The proposal, part of the wider Biotech Act package, would grant an additional year of exclusivity under Supplementary Protection Certificates for selected treatments. These would apply to medicines containing new active substances, those with different mechanisms of action compared with existing therapies, products tested in more than two EU member states, and drugs with at least one manufacturing step carried out within the bloc.

The European Commission argues the measure is necessary to attract biotech investment, strengthen domestic manufacturing, and prevent pharmaceutical innovation from shifting to other global markets. EU Health Commissioner Olivér Várhelyi defended the proposal, saying that without stronger incentives, many new treatments would not reach Europe until after patent expiry elsewhere.

He also rejected concerns over cost implications, suggesting that greater investment in preventive healthcare could offset long-term spending pressures on national health systems.

However, several member states raised strong objections, warning that longer exclusivity periods could delay the entry of cheaper biosimilar alternatives and increase strain on public healthcare budgets. Critics also questioned whether the proposal sufficiently considers unequal access to medicines across the EU.

Malta highlighted stark disparities in availability, noting that it had access to only 17 innovative medicines approved between 2020 and 2023, compared with more than 150 in Germany and over 140 in Italy. Officials warned that extending monopoly rights could deepen such inequalities.

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Estonia echoed these concerns, stressing the need for a balanced approach that considers affordability, accessibility, and the long-term sustainability of national health systems.

Other delegations, including Poland and France, questioned whether the Commission had provided enough evidence to justify the policy shift. Some ministers pointed out that the proposal was not accompanied by a standalone impact assessment and relied instead on broader pharmaceutical sector analysis.

Despite disagreements, there was broad agreement on the need to simplify clinical trial procedures, reduce administrative burdens, and avoid regulatory overlap. Many countries also emphasised the importance of strengthening biosimilar markets, which are seen as critical to lowering drug costs and improving patient access across the EU.

France and several other member states argued that biosimilars play a key role in ensuring system resilience and affordability, particularly for smaller healthcare systems.

The debate reflects a broader fault line in EU industrial policy: how to encourage innovation without undermining access and cost control.

As negotiations continue, attention is shifting to Ireland, which will assume the Council of the EU presidency next. Irish Health Minister Jennifer Carroll MacNeill urged member states to accelerate discussions, citing increasing global competition in biotechnology.

She said the external environment makes rapid progress essential and confirmed that Ireland will prioritise clinical trial reform and measures to strengthen Europe’s biomanufacturing capacity.

MacNeill added that Europe must streamline regulatory frameworks to remain competitive, warning that delays could allow other regions to pull further ahead in biotech innovation.

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Wildfire Smoke Poses Growing Air Pollution Risk for Pregnant Women, Study Finds

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Wildfire smoke is becoming an increasing threat to pregnant women as climate change drives more frequent and intense fires, potentially undermining improvements made in air quality through reductions in pollution from transport and industry.

A new study published in Frontiers in Environmental Health examined exposure to fine particulate matter, known as PM2.5, from wildfires across the United States between 2003 and 2019. Researchers found that prenatal exposure to wildfire smoke more than doubled during the 17-year period.

The increase was particularly significant in western US states, where wildfire seasons have become longer and fires have grown more severe. Researchers found that wildfire smoke was responsible for about 65% of days when air pollution reached levels considered unsafe during pregnancy.

The findings suggest that progress in reducing pollution from human activities is being partly offset by emissions from wildfires.

“Increasing wildfire activity is systematically offsetting prenatal air quality gains,” researchers said, warning that the trend could place a disproportionate burden on low-income, rural and Indigenous communities as wildfire activity continues to intensify.

PM2.5 consists of microscopic particles that can travel deep into the lungs and enter the bloodstream. Exposure during pregnancy has previously been associated with health problems including premature birth and low birth weight.

Researchers also noted that particles produced by wildfires may pose additional risks because their chemical composition can differ from pollution produced by traffic and industrial activity. This could make wildfire smoke particularly concerning for people who are more vulnerable to air pollution.

The findings have implications beyond the United States, as Europe has also experienced increasingly severe wildfire seasons in recent years.

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Countries including Greece, Portugal, Spain and France have faced major fires during successive summers, with smoke sometimes spreading across national borders. European climate and health authorities have warned that rising temperatures are contributing to conditions that increase the likelihood and intensity of wildfires.

The growing exposure has raised concerns about how public health systems can protect vulnerable groups as climate-related risks increase.

Experts say governments may need to strengthen guidance for pregnant women and other groups at higher risk from smoke exposure. Measures could include improved wildfire smoke forecasting, earlier health warnings and greater access to clean indoor air during periods of severe pollution.

The research highlights a challenge facing environmental policymakers. While decades of measures have reduced pollution from vehicles, industry and other human activities, climate change is creating additional sources of harmful air pollution.

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Good Sleep May Matter More Than Diet or Exercise for Teenagers’ School Performance

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Good sleep may have a stronger influence on teenagers’ academic performance and social lives than diet, exercise or screen time, according to new research examining the daily factors that shape young people’s well-being.

The findings suggest that sleep could be particularly important for children experiencing symptoms of depression, anxiety or psychotic-like experiences, which have been linked to difficulties at school and in relationships.

Researchers examined data from more than 6,000 children for academic performance and more than 7,000 for social difficulties. The participants were aged between 10 and 13 and were assessed on four lifestyle factors: sleep quality, screen use, physical activity and diet.

Children showing symptoms of mental health difficulties generally performed worse academically and experienced more social problems. However, researchers found that lifestyle habits appeared to explain a significant part of this relationship, with sleep standing out as the most important factor.

“We expected sleep to be important, but we didn’t expect it to stand out so clearly above other lifestyle factors, particularly screen time,” said Jason Smucny, the study’s lead author at the University of California, Davis.

Researchers said poor sleep can cause daytime tiredness, problems with concentration and weaker executive functioning, all of which can make it harder for students to learn, complete schoolwork and perform well in examinations.

Sleep may also affect relationships. Disrupted or inadequate sleep can contribute to irritability and social withdrawal, potentially making it harder for young people to communicate with friends and maintain healthy relationships.

The researchers said their findings point to sleep quality as an important pathway through which early mental health symptoms can affect everyday functioning.

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Tara Niendam, the study’s senior author, said parents, teachers and health professionals often concentrate on symptoms such as anxiety and depression, but families are also concerned about how those difficulties affect school performance, friendships and daily activities.

The research suggests that improving sleep routines could be one practical way of supporting young people facing these challenges.

Adolescents have increasingly struggled to get enough sleep, with previous research indicating that teenage sleep levels have declined over recent decades. School demands, social activities, technology use and changing schedules can all interfere with regular sleeping patterns.

The researchers stressed that better sleep cannot address every mental health problem. However, establishing consistent sleep routines may support emotional health and help young people manage the demands of school and social life.

With summer giving students an opportunity to recover from demanding school schedules, the findings highlight the potential importance of using the break to establish healthier and more consistent sleeping habits before the new academic year begins.

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Study Suggests GLP-1 Weight-Loss Drugs May Lower Fracture Risk in People With Type 2 Diabetes

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A large US study has found that GLP-1 medicines, including widely prescribed treatments such as Ozempic, may reduce the risk of serious bone fractures in people with type 2 diabetes, challenging concerns that rapid weight loss associated with the drugs could weaken bones.

Researchers reported that patients treated with GLP-1 medicines had a 21% lower risk of fragility fractures over a three-year period compared with similar patients who received DPP-4 medicines, another class of drugs commonly used to manage type 2 diabetes.

The findings are based on an analysis of health records from more than 133,000 adults aged between 50 and 90 in the United States who were treated for type 2 diabetes between 2015 and 2022.

People living with type 2 diabetes face a greater risk of fractures caused by low-energy incidents, such as falls from standing height, even though they often have normal or higher-than-average bone density. Researchers said this may be linked to reduced bone strength, changes in bone structure and faster bone loss rather than bone density alone.

The study found the greatest reductions in vertebral fractures, which declined by 32%, while hip and femur fractures fell by 30% among patients taking GLP-1 medicines.

Researchers also noted that the lower fracture risk appeared to be independent of changes in body weight or blood sugar control. This raises the possibility that the medicines may have a direct effect on bone health rather than reducing fractures simply through weight loss or improved diabetes management.

The results challenge long-standing concerns that rapid weight loss could increase fracture risk by reducing bone density. Those concerns have accompanied the growing use of GLP-1 medicines, which have become increasingly popular for treating both type 2 diabetes and obesity.

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Despite the encouraging findings, the researchers stressed that the study does not establish a direct cause-and-effect relationship. Because the research was based on observational health records rather than a randomized clinical trial, other factors may have influenced the results. Differences in physical activity, muscle strength, nutrition and existing bone health could all have contributed to the lower fracture rates.

The study also found no evidence that GLP-1 medicines reduced fracture risk among people who were taking the drugs without having type 2 diabetes. That suggests the apparent benefit may be specific to patients with diabetes and may not extend to those using the medicines solely for weight management.

The authors said additional prospective clinical trials are needed to confirm whether GLP-1 medicines provide direct protection against fractures and to determine whether any benefits continue during longer periods of treatment.

The findings add to growing research into the wider health effects of GLP-1 medicines as their use continues to expand around the world for diabetes care and weight management.

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