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EU approves biggest overhaul of medicines rules in more than 20 years

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EU approves biggest overhaul of medicines rules in more than 20 years
New EU pharmaceutical rules will change how medicines are protected from competition and supplied across Europe. | Photo: David Trinks

The EU has approved its biggest overhaul of pharmaceutical legislation in more than 20 years, introducing new rules covering medicine shortages, generic drugs, antibiotics and protections for pharmaceutical companies.

The Council of the EU adopted the new EU pharmaceutical rules on 28 September. The package follows an agreement reached with the European Parliament in December 2025.

It is the first major revision of EU pharmaceutical legislation since 2004. The reforms aim to improve access to medicines while encouraging companies to continue developing new treatments in Europe.

How will the new EU pharmaceutical rules affect medicines?

One major change concerns how long new medicines are protected from competition.

Drugmakers will receive eight years of regulatory data protection. During this period, competitors cannot use the original manufacturer’s clinical and pre-clinical trial data to seek approval for generic or biosimilar alternatives.

This will be followed by one year of market protection. Additional protection will be available for medicines meeting certain requirements.

The EU is also expanding the Bolar exemption. This allows generic manufacturers to carry out studies and other necessary preparations before existing protections expire.

As a result, generic medicines should be able to enter the market sooner once they are legally permitted.

The reforms also introduce incentives for medicines targeting rare diseases and antibiotic-resistant infections.

Orphan medicines for rare conditions will generally receive nine years of market exclusivity. Qualifying breakthrough treatments could receive 11 years.

Developers of certain new antibiotics could also receive a transferable voucher granting an additional year of protection to another medicine. The incentive is intended to encourage development of antibiotics as antimicrobial resistance becomes a growing public-health problem.

What will the EU do about medicine shortages?

Preventing medicine shortages is another important part of the new rules.

EU countries will be able to require pharmaceutical companies benefiting from regulatory protection to supply sufficient quantities of a medicine to meet patients’ needs.

Drugmakers will also face stronger requirements to warn authorities about potential shortages and take steps to prevent critical supply problems.

Medicine supplies have become a growing concern in Europe, particularly following the Covid-19 pandemic, which highlighted the bloc’s reliance on countries outside the EU for some medicines and pharmaceutical ingredients.

When will the new EU pharmaceutical rules take effect?

The changes are not yet in force.

The pharmaceutical package includes a new regulation and directive. Both still require formal adoption by the European Parliament.

Once formally approved, the legislation will be published in the EU’s Official Journal and take effect according to the timetable established in the final texts.

The reforms are designed to strike a balance between two competing priorities: getting affordable medicines to European patients sooner while maintaining incentives for pharmaceutical companies to develop new treatments.

Olivia Miller is a journalist and blogger regularly collaborating with media outlets and writing about entrepreneurship, brand authority and corporate social responsibility (CSR).

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How to Take Practical Steps Toward a Healthier Lifestyle

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How to Take Practical Steps Toward a Healthier Lifestyle
60% of the UK adults report struggling to maintain healthy habits. | Photo: Gustavo Fring

Living a healthier lifestyle than the one you’re currently leading takes commitment, but it doesn’t have to begin with dramatic changes. In the UK, around 60% of adults report struggling to maintain healthy habits, according to the Office for Health Improvement and Disparities (OHID), and nearly one in three say they feel overwhelmed by the idea of “starting over” with their wellbeing. The good news is that long‑term health improvements rarely come from grand gestures. Research from the British Journal of Health Psychology shows that small, repeatable micro‑habits — such as drinking more water, walking daily, or setting boundaries — are far more likely to stick and lead to meaningful change over time.

Prioritise Your Health

Your good health is the backbone of a great life. When you are sick or just feel out of sorts, you are not living your best life. Illness takes centre stage, and everything else falls to the wayside. Luckily, you can take control of your health by being proactive. Schedule a private health screening to catch up on your annual wellness check and screenings. Take this opportunity to discuss any concerns that have arisen since your last healthcare appointment and ask any questions you may have. Living well involves being well, and the best way to be well is to get a health screening. Ask your provider for more information regarding how to achieve your health goals. They are the perfect place to start.

Create and Enforce Healthy Boundaries

Boundaries sound like an efficient and effective idea. A boundary keeps some things in and other things out. And yet, the concept is so much easier to ruminate on than actually taking action on. In life, you will notice that some people push your boundaries. They want more of your time and more of you. They want access to you at all times and expect you to pick up their slack. This could play out at work, in your family of origin, in your friend group, or in your own home. Think about how you feel after interacting with people who cross the line or take advantage of you. Start small and have a conversation. Use “I statements” and explain how you feel when they do certain things. State that you will no longer be available or accept certain behaviours. Remember that no is a complete sentence, and your mental health is important.

Adopt a Growth Mindset

It is not enough to want to live a healthier lifestyle; you need to want to embrace the steps and do the work to get there. If you falter in your health goals, giving yourself grace is so important. Everyone missteps from time to time. Sometimes, it keeps happening. What matters is that you pick yourself up, refocus your intentions, and perhaps try a different approach to do the work to become a healthier version of yourself. Learning from your mistakes is part of the process. Giving up is not. Growing your mind is part of becoming healthy.

Small habits compound over time, and consistency matters more than intensity. | Photo: Gustavo Fring

Build Consistency Through Micro‑Habits

Small habits compound over time, and consistency matters more than intensity. Studies from University College London suggest it takes an average of 66 days for a new behaviour to become automatic — not perfect, not effortless, but familiar enough to stick. This is why micro‑habits are so powerful: they bypass the pressure of perfection and focus instead on repetition.

Start with actions that take less than two minutes: stretching when you wake up, drinking a glass of water before coffee, writing down one intention for the day, or stepping outside for fresh air between tasks. These tiny shifts help regulate stress, improve mood, and build momentum. Over time, they create a foundation that makes bigger lifestyle changes feel achievable rather than intimidating.

Embracing a healthier lifestyle is an ongoing process, not a single decision. Prioritise your physical and mental health, set boundaries that protect your energy, and allow yourself to learn and adapt along the way. Small, consistent actions — from daily movement to regular health screenings — create a cumulative impact that supports long‑term wellbeing. When you choose to adopt a growth mindset, you’re choosing to invest in yourself every day, building a life that feels balanced, intentional, and genuinely healthy.

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How Grief Affects Sleep Patterns and Physical Health

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How Grief Affects Sleep Patterns and Physical Health
Grief is not confined to the mind. | Photo: Marieke de Jong/ Slaapwijsheid

One of the first obvious physical change after a significant loss is sleep. Falling asleep is difficult and sleep overall is very disrupted. Your mind replays hospital rooms, last conversations, unanswered questions. Your chest feels tight. Your heart is alert. You are exhausted, but your body will not fully switch off.

What many people do not realise is that grief registers in the body as a threat. The attachment bond has been severed, and from a biological perspective, that loss signals danger. The nervous system shifts into fight-or-flight mode, a state designed for survival, not rest.

Sleep requires safety.
Grief feels like the opposite.

A mismatch between expectation and reality

Grief is often described as an emotional experience. But it is also physiological. It moves through the body before it ever becomes language. Adults and children alike experience this disruption. After I lost my father at the age of seven, for many months after his death, I would lie in bed each night telling myself, this is just a nightmare. I will wake up tomorrow morning and everything will be as it used to be. My mind was desperately trying to reverse reality.

Years later, after losing my brothers, the nights carried a different texture but a similar vigilance. My body felt tired beyond measure, yet my mind remained alert. Tired but wired. This is not unusual. Neuroscientist Mary-Frances O’Connor explains that the brain forms deep attachment circuits around the people we love. When someone dies, those circuits do not immediately update. On some level, the brain still expects them to exist in the world. That mismatch between expectation and reality creates a huge amount of stress. And we know that stress affects sleep.

When we experience loss, the body’s stress response system activates. Cortisol levels can rise. The autonomic nervous system shifts toward vigilance. The very systems designed to help us survive acute danger can remain partially switched on for weeks or months. Neuroscientist Andrew Huberman has described how elevated stress hormones disrupt the architecture of sleep, reducing deep and REM cycles. REM sleep, in particular, plays a role in emotional processing. When it becomes fragmented, emotional regulation during the day becomes more difficult. This creates a feedback loop.

Poor sleep intensifies emotional sensitivity.
Heightened emotion disrupts sleep further.

There is also the “body budget” to consider, a concept developed by neuroscientist Lisa Feldman Barrett. She describes how the brain continuously manages energy resources: sleep, nutrition, movement, and social connection. Grief is metabolically expensive. It draws heavily on this budget. Even when someone appears outwardly functional, their internal systems are working harder than usual. Concentration requires more effort. Decision-making feels heavier. The immune system can become temporarily compromised.

Further symptoms of grief

Many grieving people report increased colds, flares of autoimmune symptoms, digestive issues, or unexplained aches. Research supports this observation. Acute grief has been associated with elevated inflammation markers and changes in immune function. The body does not separate emotional stress from physical stress. It responds to both. Julia Samuel, a psychotherapist specialising in grief, often reminds us that bereavement is one of the most significant stressors a human can experience. If we would expect physical repercussions after a major surgery or trauma, it makes sense that profound emotional loss would also register physically. Yet culturally, we rarely prepare people for this.

We speak about sadness.
We speak about missing someone.
We do not always speak about night sweats, jaw tension, digestive changes, or the way the heart can feel as though it is racing in a quiet room.

There is even a recognised medical condition often called “broken heart syndrome” or  “stress-induced cardiomyopathy”, in which acute emotional distress temporarily affects heart function. It is rare, but it illustrates a broader truth: the heart and brain are in constant dialogue. Sleep disturbance during grief is not only about stress hormones. It is also about meaning.

Night removes distraction. During the day, routines hold us. Conversations buffer us. At night, silence expands. The absence can feel louder. The mind returns to images, regrets, conversations replayed. Grief disrupts ordinary perception, the world feels altered, unfamiliar. That disorientation does not switch off when the lights go out. The body remembers what the mind is trying to process.

For some, sleep becomes avoidance, an attempt to escape pain. For others, insomnia becomes a form of unconscious vigilance. Over time, as the brain slowly updates its attachment maps, sleep often stabilises. But this can take longer than people expect. In the early stages of grief, self-judgement around sleep can add unnecessary strain. People often say, “I should be coping better,” or “I just need to be stronger.” Yet sleep disruption after loss is not a failure of character. It reflects a nervous system recalibrating.

Small physiological supports can help, regular light exposure in the morning, gentle movement during the day, limiting late-night stimulation, maintaining consistent sleep times where possible. These are not cures for grief. They are signals of safety to the body. And safety allows rest.

Grief is not confined to the mind

There is something quietly humbling about recognising that grief is not confined to the mind. It is cellular. Hormonal. Neurological. It travels through muscle and breath. When someone says, “I am exhausted,” after months of mourning, it is often literal. The body has been carrying the weight. With time, and with patient regulation, the nervous system learns that the immediate threat has passed. Cortisol rhythms rebalance. REM sleep lengthens again. The immune system steadies. The body budget slowly recovers.

Grief does not vanish. But its physiological intensity often softens. Understanding this can reduce secondary suffering, the anxiety about why the body feels different. When we frame sleep disturbance and physical symptoms as adaptive responses rather than defects, something eases. Your body is not betraying you. It is responding to love, loss, and the effort of adaptation.

And in that response, even the sleepless nights carry a kind of logic, it is your system learning, slowly, how to live in a world that has changed forever.

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Plastic Surgeons Call for Ban on Breast Fillers Over Cancer Fears

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Plastic Surgeons Call for Ban on Breast Fillers Over Cancer Fears
Breast cancer affects 1 in 7 women in the UK. | Photo: NCI

Britain’s leading plastic surgeons are calling for an immediate ban on synthetic dermal fillers being injected into breasts, warning the procedure carries “unacceptable” risks including infection, disfigurement and the potential masking of breast cancer.

The British Association of Aesthetic Plastic Surgeons (BAAPS) says there is “no justification whatsoever” for injecting fillers into breast tissue, describing the trend as high risk with little proven benefit. The call is backed by the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) and patient safety group Save Face.

Cancer Detection Concerns

Surgeons warn fillers can cause inflammation, infection and hard scar tissue (granulomas), potentially making early breast cancer harder to detect on scans.

Breast cancer affects 1 in 7 women in the UK — more than 44,000 annually. BAAPS says any procedure that could obscure early warning signs is “simply indefensible.”

Macrolane, a breast filler product, was withdrawn in 2012 over safety concerns. However, surgeons say similar substances are still being injected, often with limited regulation.

Serious Complications leading to Operations

Reported risks include severe mastitis, abscesses requiring surgery, hard or misshapen lumps, filler migration, chronic pain and interference with breastfeeding. Some women have needed major operations to remove the material.

BAAPS President Nora Nugent stressed that the breast is “a gland with biological function, not just cosmetic tissue,” warning infections may cause lasting damage.

Weak Regulation for Fillers

Often marketed as quick “lunchtime” procedures, fillers are promoted as a non-surgical fix for volume loss or sagging. But BAAPS says results are modest and can appear unnatural over time.

Surgeons are also concerned that fillers can be administered by individuals without surgical training and with no consistent standards for clinics or managing complications.

BAAPS, alongside BAPRAS, the Joint Council for Cosmetic Practitioners and the Royal College of Surgeons of England, has called for tighter controls on high-risk filler procedures, but breast fillers remain largely unrestricted.

Safer alternatives — including fat transfer, implants and breast lift surgery — exist when performed by trained plastic surgeons and offer stronger safety profiles.

“In the presence of safer alternatives, there is simply no place for this practice in the UK,” said BAAPS spokesperson Elaine Sassoon. “We are calling for a ban.”

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