Tag: patient access

Speed is everything for patients: together we can bring medicines faster

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Working in our industry brings huge responsibility. We deal with people’s lives, and our  medicines give people an opportunity to improve their health, often at the most overwhelming time for them. I had a strong reminder of that recently.

Last month, I met with a colleague, Heiko, who lives in Germany. His young daughter has central nervous system (CNS) neuroblastoma — a type of cancer that tends to affect children under the age of five.

Heiko and his family have been navigating the health system for months, including an overload of information in the form of complex ‘oncological-speak’, treatment guidelines and health insurance claims. They have also been dealing with constant travel to specialist centers — all while juggling the emotional burden of caring for a sick child and the daily challenges of home and work life.

He shared something that stuck in my mind the night I spoke with him, which serves as an important reminder for all of us working in health care.

“Trust must be bigger than fear.”

When their health is at stake, friends, families and colleagues put their trust in their local health care system — every part of it, including industry — in the hope of protecting the future for them and their loved ones.

As Heiko put it to me, “Speed is everything. If you gain enough speed, you gain enough time. And if you have time, you have the hope of more options that can help you.”

Faster, more equitable access to new, life-saving medicines for people living in Europe is a goal that I believe we all share. There are challenges in achieving this, but we at Roche are committed to addressing these, together with everyone involved.

It is the inequality in access to medicines that is untenable.

Teresa Graham, CEO, Roche Pharmaceuticals, and chair EFPIA’s Patient Access Committee | via EFPIA

The average time that patients in the EU wait to get access to a new medicine is around 517 days. Uptake of new technologies can be low and slow, but it is the inequality in access to medicines that is untenable. If you have cancer in Germany, you may need to wait, on average, 128 days to access a new medicine, but if you are a patient in Romania it will take you 918 days to receive the same treatment.

I am concerned that Europe’s policymakers believe this can be fixed with legislation alone. And, even if it could, families like Heiko’s do not have the luxury of waiting four to five years for the ongoing revision to the EU pharmaceutical legislation to attempt to resolve these issues.

Improving access to medicines requires solutions that are developed in partnership with everyone who has a stake in their delivery: industry, member states, health regulators, payers, patients and health care providers. With the right ambition and desire for collaboration, we can act now.

The crucial first step is for governments and policymakers to treat spending on health care and innovation as an investment in economic growth and societal advancement. Improving health care and expanding access to innovation are vital for reducing pressure on health care systems, maintaining a healthy and productive society, and driving future economic growth.

Governments and policymakers have a pivotal role in enabling and encouraging this cycle of improved health and economic benefit. We must take a strategic view of investing in innovation, acknowledging the wider societal value it provides, and find sustainable ways to manage immediate fiscal challenges that do not limit or delay access to new medicines and technologies.

The industry is also driving changes. One concrete commitment pharmaceutical companies have made is to file new medicines for pricing and reimbursement in all member states within two years of EU approval of a new medicine. This will improve timely access to the latest innovations.

The industry has also established a portal for tracking access delays and ensuring companies are held accountable in meeting the two-year filing commitment.

With the right ambition and desire for collaboration, we can act now.

With multiple ongoing legislative changes currently taking place in Europe — from the revision of the EU’s Pharmaceutical Legislation, to the EU’s reform of Health Technology Assessment (HTA) and the introduction of the European Health Data Space (EHDS) — we have a unique opportunity to build a stronger and better European environment for life sciences and health care that serves patients’ best interests. One major opportunity for collaboration is the implementation of the EU’s HTA regulation. This aims to address access delays by streamlining and accelerating highly fragmented HTA processes across Europe. There is only one year to go before this either becomes a meaningful contributor to faster access decisions for patients or — if not adequately in focus during 2024 — risks becoming an additional hurdle for patient access to essential treatments. In order to avoid this scenario, industry involvement in the implementation of EU HTA is crucial to leverage expertise, co-design relevant processes, and ultimately ensure a workable system.

Such actions can reduce some of the delays in accessing new medicines, but they will not solve everything. The majority of delays come from the variation and delays in individual countries’ reimbursement and health care systems. That is why it is critical that member states, payers and health systems collaborate with industry to develop tailored access solutions. 

However, there are also proposals on the table today that are concerning and at face value will not lead to improved access for patients. For instance, the EU Commission is proposing to reduce a company’s intellectual property rights — specifically regulatory data protection (RDP) — if a medicine is not available in all member states within two years of receiving marketing authorisation. This would only hinder innovation, without delivering faster, more equitable access to new medicines.

If this were to go ahead as proposed, Europe would become a less attractive place for research. A recently-published study on the impact of the European Commission’s proposal estimated that it would reduce Europe’s share of global R&D investment by one-third by 2040.

I firmly believe this proposal must be reconsidered and focused on policy solutions that ensure patients in Europe continue to benefit from innovation.

As Heiko says, speed, time and hope are all people have. Often, patients are waiting for the next innovation, during which time, their disease progresses or their condition deteriorates. This makes the next clinical trial, the next regulatory approval, the next standard of care, the next reimbursement decision absolutely vital for those who simply cannot wait.

Across industry, there are more than 8,000 new medicines in the global pipeline today. This is the hope Heiko needs, and families like his are trusting us all to deliver.

Speaking with Heiko reminded me that the most effective treatment is the one that makes it to the patient when they need it. It is now our collective responsibility to find the path to making this happen for patients everywhere in Europe.



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Why we need to improve heart health in Europe

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Cardiovascular diseases (CVDs) are the number one killer in Europe. They cost the EU an estimated €282 billion in 2021, larger than the entire EU budget itself.[1] Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.[2]

Behind this data are individual stories of suffering and loss, of lives limited and horizons lowered by, for example, heart attack and stroke. These diseases directly affect every community in every country. And they strain our health services which must respond to cardiac emergencies as well as the ongoing care needs of chronic CVD patients.

Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.

Cardiovascular health is a priority not just because of the scale of its impact, but because of the scope we see for significant advances in outcomes for patients. We should take inspiration from the past: between 2000 and 2012, the death rate from CVDs fell by 37 percent in the five largest western European countries (France, Germany, the U.K., Spain and Italy).[2] This progress was achieved through a combination of medical innovations, and supported by a mix of health care policies and guidelines that propelled progress and improved patients’ lives.

New treatments can now help prevent strokes or treat pulmonary embolisms. Others can delay kidney disease progression, while at the same time preventing cardiovascular events.

Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.

And the research continues. Precision medicines are in development for inherited CVD-risk factors like elevated lipoprotein(a), which affects up to 20 percent of the population.[3] A new class of anti-thrombotics promises to bring better treatments for the prevention of clotting, without increasing the risk of bleeding. New precision cardiology approaches, such as gene therapy in congestive heart failure, are being investigated as potential cures.

Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.[4]

Getting the definitions right

This year’s World Heart Day, spearheaded by the World Heart Federation, comes amid the revision of the EU pharmaceutical legislation. The European Commission’s proposal of a narrow definition of unmet medical need, which could hamper innovation is causing deep concern across stakeholders.

Instead, a patient-centered definition of unmet medical need taking the full spectrum of patient needs into consideration, would incentivize more avenues of research addressing the needs of people living with chronic conditions. It would provide a basis for drafting the next chapter in the history of cardiovascular medicines — one that we hope will be written in Europe and benefit people in the EU and beyond. Not only would this inspire advances that help people to live longer, but it would also improve quality of life for those at risk of, and affected by, cardiovascular events.

Unmet medical need criteria currently included in the draft Pharmaceutical Legislation would do a disservice to patients by downplaying the chronic nature of many CVDs, and the importance of patient-reported outcomes and experience.[5] And many of the advances seen in recent decades would fall short of the narrow definition under consideration. This limited approach disregards incremental innovation, which might otherwise reduce pain, slow disease progression, or improve treatment adherence by taking account of patient preferences for how therapies are administered.

Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.

At this moment it is unclear how the unmet medical need criteria in the legislation will apply to these and other situations. Policymakers should create a multistakeholder platform with the space to discuss patients’ needs, getting expert views from medical societies, patients and industry to better understand the innovation environment. The European Alliance for Cardiovascular Health (EACH), a multistakeholder network comprised of 17 organizations in the CVD space in Europe, stands ready to inform policymakers about the CVD burden and the pressing needs of patients. [6] EACH not only supports the EU´s endeavor to develop more policies on CVD, it also supports and promotes the idea of an EU Cardiovascular Health Plan to work towards better patients’ health care across the EU and more equal health standards. So far, structured discussions with such stakeholders do not sufficiently take place, and we risk missing those opportunities, and lose in both patient access as well as R&D attractiveness of the EU.

Primary and secondary prevention

As well as driving future innovation, Europe must also make the best possible use of the tools we have now. We must do what works — everywhere.

At the heart of this approach is prevention. Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.[7] Primary prevention can dramatically reduce rates of heart attack, stroke and other CVDs. Secondary prevention, which includes screening and disease management, such as simple blood tests and urine tests, as well as blood pressure and BMI monitoring, has a key role to play in containing the burden of disease. [8]

Joint cardiovascular and diabetes health checks at primary care level, taking an evidence-based approach, would help diagnose and treat CVD before the onset of acute symptoms.[9] By following current treatment guidelines and protocols, health care professionals across Europe can help to prevent complications, improve health outcomes for patients and save health care costs. Also here, a multistakeholder approach is key. Policymakers should not miss out on listening to the CVD multistakeholder alliances that have already formed — at EU and at EU member countries level, as for example EACH. These partnerships are great ways for policymakers to better understand the needs of patients and to get the experts’ views.

Research-driven companies exist to meet the needs of patients in Europe and around the world. We need to create an environment that enables companies to embark on complex and unpredictable trials. That means having the rights incentives and clarity on the regulatory pathway for future treatments.

[1] https://www.escardio.org/The-ESC/Press-Office/Press-releases/Price-tag-on-cardiovascular-disease-in-Europe-higher-than-entire-EU-budget

[2] https://iris.unibocconi.it/retrieve/handle/11565/4023471/115818/Torbica%20EHJ%202019.pdf

[3] https://www.acc.org/Latest-in-Cardiology/Articles/2019/07/02/08/05/Lipoproteina-in-Clinical-Practice

[4] https://www.efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/transforming-the-lives-of-people-living-with-cardiovascular-diseases/cvd-dashboards

[5] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

[6] https://www.cardiovascular-alliance.eu/

[7] https://www.ahajournals.org/doi/10.1161/STROKEAHA.119.024154

[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331469/

[9] https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/because-we-can-t-afford-not-to-let-s-make-a-joint-health-check-for-cardiovascular-disease-cvd-and-diabetes-happen/



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Beyond forgetfulness: Why we must act on Alzheimer’s disease now

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In the face of an increasingly aging population, today’s reality reveals a harsh truth: health systems in the EU and beyond are ill-equipped to provide early and timely diagnosis of Alzheimer’s disease and embrace innovative treatments that could help to preserve memory and, with it, independence.  

Recent advances suggest that timely intervention may hold the promise to slow the memory decline in Alzheimer’s disease, making early diagnosis more critical than ever before. Yet without the necessary health care infrastructure in place to diagnose and provide treatment, we risk missing the crucial early window and the opportunity to delay — and hopefully in the near future prevent — distressing symptoms for patients and heartbreaking experiences for families.  

The EU and its member countries have the opportunity to be remembered for leading in this space by increasing funding for research, improving health care infrastructure to support accurate diagnosis and timely intervention, and enhancing support services at a national and regional level. The forthcoming European Parliament elections in June 2024 are the ideal moments to make that pledge. For individuals, families and health care systems, Alzheimer’s disease is a ticking time bomb unless we invest in our future health today.  

The EU is not prepared for Alzheimer’s disease  

In Europe, approximately 7 million people are affected by Alzheimer’s disease, a number set to double to 14 million by 2050.1 On top of the physical and emotional distress this will cause, there are direct financial and social implications on families and communities, with Alzheimer’s costs expected to reach a staggering €250 billion by 20302 — bigger than the GDP of Portugal3 — placing an additional and substantial weight on global health care systems that are already struggling under cost and capacity burdens.4 

Timely diagnosis stands as a cornerstone in determining the appropriate treatment for patients.

That’s why MEP Deirdre Clune is leading the call for a European Parliament hearing to discuss a focused EU strategy on dementia and Alzheimer’s disease. “Timely diagnosis stands as a cornerstone in determining the appropriate treatment for patients,” argues Clune. “Therefore, the EU must create a strategic framework which lays out clear recommendations for national governments and recognises the toll of dementia and Alzheimer’s disease on societies across Europe, encourage innovation and take on board best practices to develop effective and efficient approaches. Together, with a unified approach and firm commitment, the EU can pave the way for better Alzheimer’s care.”

In the next EU political mandate, policymakers must answer the call by developing a comprehensive EU Beating Dementia Plan that specifically addresses the unique challenges posed by Alzheimer’s disease and building on established coordinated action plans for other significant health burdens, such as the EU Beating Cancer Plan. The European Brain Council and EFPIA’s, RETHINKING Alzheimer’s disease White Paper is a useful resource, calling for policymakers to rethink Alzheimer’s and offering policy recommendations to make tangible changes to improve the lives of people living with the disease.  

EU member countries must commit to investing in diagnostic infrastructure, technology and integrated care that can help to detect Alzheimer’s disease at an early stage and ensure timely intervention resulting in the preservation of memory and, thereof, independent living and normal social functioning.  

Laying the foundations at national level  

While action is certainly needed at the EU level, huge opportunity lies at the national and regional levels. Each member country has the chance to apply well-funded national dementia plans that tailor their strategies and responses to address the distinct needs of their populations, making a real and meaningful impact on the people and health systems in their country.  

Inspiration stems from Italy, which recently launched its Parliamentary Intergroup for Neuroscience and Alzheimer’s, dedicating its efforts to raising awareness, fostering discussions among national and regional institutions, promoting clinician and patient involvement, supporting novel research, implementing new diagnostic models, and strengthening patient access to care. 

Italian MP Annarita Patriarca, co-host of the Parliamentary Intergroup, affirms: “Primary responsibility of a member state is to ensure to all citizens the greatest standards of diagnosis and access to treatment and care. Thus, it is necessary to put in place a strong collaboration between the public and private sector to strengthen investments in neurological diseases. Improving patients’ diagnostic and care pathways, especially in a disease area like AD with such a high unmet medical need and societal impact will be the core focus of the intergroup.” 

Additionally, during the Alzheimer’s and Neuroscience Conference: a priority for the country in July, members of the Italian Parliament importantly put forward legislative and regulatory solutions to ensure an early and accurate diagnosis. 

Leading the conversation on the international stage   

Amid the growing burden of Alzheimer’s disease globally, this is a moment for policymakers to hold each other accountable. Member countries are uniquely placed to do this within the EU but also across the wider health care ecosystem, calling on countries and leaders to honor prior commitments that prioritized investment in relieving major health burdens, including Alzheimer’s.  

Encouragingly, the May G7 Hiroshima Leaders’ Communiqué specifically recognized and supported dementia as a freestanding issue, breaking away from the typical categorization with NCDs. Moreover, the G7 health ministers published a joint Communiqué spotlighting the priority to “enhance early detection, diagnosis and interventions, including developing care pathways and capability and capacity building of health and primary care providers by strengthening primary health care (PHC)”.  

These promising steps mean that Alzheimer’s disease is beginning to gain the recognition it deserves but also acts as a line in the sand to ensure complacency doesn’t creep in. Collectively, EU countries must assume a leading voice within the international fora, ensuring that Alzheimer’s disease remains a global health care priority and receives the investment it warrants. 

Time to commit to action in Alzheimer’s disease  

September marks World Alzheimer’s Month, and its theme Never Too Early, Never Too Late, reiterates the importance of early diagnosis. It presents a valuable foundation to initiate discussions on country- and regional-level strategies to drive and strengthen diagnostic infrastructure and services for the prevention, diagnosis, case management, monitoring and treatment of Alzheimer’s disease. 

Unless we act now, a generation of people will be forgotten as they begin to lose their memories.

“Unless we act now, a generation of people will be forgotten as they begin to lose their memories,” shares Frédéric Destrebecq, executive director of The European Brain Council. “By recognizing the urgency of the situation and making concerted investments, we can forge a path toward a more compassionate, empowered future for individuals, families and communities impacted by Alzheimer’s, and remember all those who’ve been lost to this devastating disease.”

It is never too early, never too late, to be remembered for taking action against this debilitating disease.  

References:  

1 – Jones RW, Mackell J, Berthet K, Knox S. Assessing attitudes and behaviours surrounding Alzheimer’s disease in Europe: key findings of the Important Perspectives on Alzheimer’s Care and Treatment (IMPACT) survey. The journal of nutrition, health & aging. 2010 Aug;14:525-30.  

2 – Cimler R, Maresova P, Kuhnova J, Kuca K. Predictions of Alzheimer’s disease treatment and care costs in European countries. PLoS One. 2019;14(1):e0210958. Published 2019 Jan 25. doi:10.1371/journal.pone.0210958 

3 – Published by Statista Research Department, 20 J. GDP of European countries 2022. Statista. June 20, 2023. Accessed August 1, 2023. https://www.statista.com/statistics/685925/gdp-of-european-countries/. 

4 – The Economist. Why health-care services are in chaos everywhere. Available at:  https://www.economist.com/finance-and-economics/2023/01/15/why-health-care-services-are-in-chaos-everywhere. Accessed: July 2023.  



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Labs: the (overlooked) building block of Universal Health Coverage

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Hepatitis C (HCV) — a potentially life-threatening virus that infects 1.5 million new people around the world every year — is highly treatable if diagnosed early.[1]

Unfortunately,  access to quality screening is far from universal. Countries like Egypt — one of the countries with the highest prevalence of HCV in the world — demonstrate the impact screening can have. In 2015, HCV was prevalent in an estimated 7 percent of the country’s population and accounted for 7.6 percent of the country’s mortality, presenting a significant health care and societal burden.[2]

But since then, Egypt has turned a corner. In 2018, the Egyptian Ministry of Health and Population launched a massive nationwide HCV screening and treatment campaign as part of its 2014-2018 HCV action plan.[3] The campaign’s results were inspiring: by July 2020, Egypt had screened more than 60 million people[3] and treated 4 million residents.[2] Today, Egypt is set to be the world’s first country to eliminate HCV within its borders.[2]

The results of Egypt’s HCV screening program speak to diagnostics’ power in contributing to improved health outcomes around the world. Among the essential components of any health system is the capacity for prevention, which includes timely screening and detection. But a preventive approach based on timely diagnosis won’t work without the right infrastructure in place.

Strong laboratories as a cornerstone of building better health care

Matt Sause, CEO Roche Diagnostics | via Roche

The World Health Organization (WHO) highlights the critical role well-functioning laboratory services play in health systems with good reason.[4] Around the world, clinicians increasingly rely on  laboratory tests for diagnostic and treatment decisions. These tests help them make more informed decisions that result in better care and potentially improved outcomes for patients.

The challenges facing labs today — and tomorrow

Two key challenges facing laboratory systems today are underfunding and insufficient resources. Despite their central importance, laboratories struggle to garner the political and financial support they need to be as effective as possible. For example, it’s estimated that while lab results drive approximately 70 percent of clinical decision making, laboratories make up only 5 percent of hospital costs.[5]

After all, it’s the health care systems with strong, resilient labs that will be best placed to manage future pandemics and ever-growing health threats like heart disease and dementia.

What’s needed is a political commitment to provide everyone with access to accurate and timely diagnosis that paves the way to effective treatment and health. And putting this commitment into practice can only be achieved and sustained through coordinated multistakeholder efforts and public—private partnerships. This is not just a worthwhile investment for patients, but also the wider health care system in the long run. After all, it’s the health care systems with strong, resilient labs that will be best placed to manage future pandemics and ever-growing health threats like heart disease and dementia.

Another challenge is the health care workforce. Effective use of diagnostics requires qualified people to drive it, with expertise in pathology and laboratory medicine. Yet the world currently faces a laboratory staffing shortage. For diagnostics in particular, baccalaureate degree programs in laboratory science have previously been on the ‘endangered list’ of allied health professions.[6] In the end, inadequately trained staff, frequent turnover and scheduling problems all make quality lab results more difficult to guarantee.

This UHC ambition is only possible when backed by a network of strong laboratories that help ensure individuals can access high-quality diagnostics services without financial burden in all health care systems.

And that’s not all: inadequate infrastructure and staffing shortages are more present in low-income, rural communities, which exacerbate the broader diagnostics gap troubling global health care today. Many low-income countries lack an integrated laboratory network that can fully provide high-quality, accessible and efficient laboratory testing services for the entire population. In fact, a commission convened by The Lancet concluded that 81 percent of these populations have little or no access to diagnostics.[7]

The path to Universal Health Coverage

Put simply, innovative diagnostics are only meaningful if they reach people where and when they’re needed. Advancing this equity is at the heart of the WHO’s vision for Universal Health Coverage (UHC) by 2030. The goal? To guarantee all people have access to high-quality services for their health and the health of their families and communities, without facing financial hardship.

This UHC ambition is only possible when backed by a network of strong laboratories that help ensure individuals can access high-quality diagnostics services without financial burden in all health care systems. To do this, UHC should explicitly include diagnostics services. Financially, it’s savings from screening, early diagnosis and targeted treatment that make UHC feasible. Health care systems will have to undergo a systemic shift from focusing on treatment to focusing on prevention. And that’s just not possible when clinicians don’t have access to fast, accurate and cost-efficient lab results to inform their clinical decision-making. Policies and regulations that safeguard UHC goals of access and health equity are essential to make progress toward UHC.[8] The Saving Access to Laboratory Services Act (SALSA), in the United States, is an example of how national policies can help to ensure sustainable laboratory networks and contribute to equitable access to essential healthcare.

Stronger labs can not only help health care systems make savings in the routine management of population health; investing in them also helps to reduce costs and prepare in advance for any future public health crises.

This year has already seen encouraging progress toward achieving UHC through enhanced diagnostics capacity. The adoption of the resolution on strengthening diagnostics capacity at the World Health Assembly in May was an important signal of growing international political support for diagnostics. It was also a call to action. The next step for this month’s United Nations General Assembly and Sustainable Development Goals (SDG) Summit is channeling political support for diagnostics into the development of an action-oriented declaration.

To put us closer to UHC, this declaration should commit to ensuring that national health plans include access to timely detection and prevention. That starts with supporting laboratory systems and establishing National Essential Diagnostics Lists that identify the most critical diagnostic tests to help diagnose patients quickly and accurately so that they can receive needed treatment. At Roche, we’re advocating that governments, industry, civil society and other policy stakeholders will come together around concrete plans and shared resources that strengthen diagnostics and the lab infrastructure that makes them effective. In line with our commitment to increase patient access to important diagnostic solutions by 2030, we plan to do our part.

[1] Hepatitis C. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c (Accessed 22.08.2023)

[2] Egypt’s Ambitious Strategy to Eliminate Hepatitis C Virus: A Case Study. Hassanin, A. et al. Available at:   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087425/ (Accessed 22.08.2023)

[3] Hepatitis C in Egypt – Past, Present, and Future. Roche Diagnostics. Available at: https://diagnostics.roche.com/global/en/article-listing/egypt-s-road-to-eliminating-hepatitis-c-virus-infection—a-stor.html (Accessed 22.08.2023)

[4] Monitoring the Building Blocks of Health Systems. World Health Organization. Available at: https://apps.who.int/iris/bitstream/handle/10665/258734/9789241564052-eng.pdf (Accessed 14.07.2023)

[5] The Cost-effective Laboratory: Implementation of Economic Evaluation of Laboratory Testing. Bogavac-Stanojevic N. & Jelic-Ivanovic Z. J Med Biochem. Volume 36, Issue 3, 238 – 242. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287218/

[6] Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century: Workshop Summary. National Academy of Sciences. Available at: https://www.ncbi.nlm.nih.gov/books/NBK215247/ (Accessed 14.07.2023)

[7] Essential diagnostics: mind the gap. The Lancet Global Health. Available at: https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00467-8/fulltext (Accessed 14.07.2023)

[8] Private Sector Commitments To Universal Health Coverage. UHC Private Sector Constituency 2023 Statement. https://www.uhc2030.org/fileadmin/uploads/UHC2030_Private_Sector_Commitments_Statement_April2023.pdf (Accessed 29.08.2023)



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Putting health back in health care

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Advances in medical science and technology are rapidly changing and as we saw with the pandemic, diagnostic tests play a pivotal role in health care decision making. They inform treatment decisions, save costs and, most importantly, deliver better outcomes for patients. Unfortunately, these life-changing innovations are all too often not available to many of the people who need them most. Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.

If you’re following the policy trend at large — or even if you’re not — this is where we inevitably turn to discussions of the role of Universal Health Coverage (UHC) in the pursuit of better access to screening and diagnosis. Population health is not only in the best interest of individual countries, but as evidenced by a global pandemic, it is important to global health as well. UHC — ensuring people can access the health care they need, when they need it, without financial hardship — is foundational to improving world health care.  

Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.

So, where do we start? With better access to diagnostics.

After the world faced a global pandemic and pulled together, we all learned vital lessons which must not be forgotten. First and foremost, we saw that by working together and sharing information early, we could develop diagnostics and vaccines faster. This learning must extend beyond times of crisis.

We also saw that health systems with well-developed diagnostics infrastructure were more effective at containing and controlling the pandemic. And they were better able to continue providing essential diagnostic tests and treatment monitoring for patients with other diseases such as cancer.        

Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.

As the world responded to urgent calls for better access to COVID-19 tests, hopes were also expressed that this would spark innovation leading to widespread testing, vaccines and treatments, which ultimately would reduce the spread of the pandemic.

After the World Health Organization (WHO) declared COVID-19 as a public health concern, the urgency galvanized companies to work at full speed. The first Polymerase Chain Reaction (PCR) tests for SARS-CoV-2 were available for limited laboratory use within eight days. Only 64 days later PCR tests were authorized for use and available for scaled-up testing in major health centers.[1]

Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.

As reported by the Lancet Commission, investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.

Driven by necessity, countries invested in diagnostics capabilities to fight the virus and, as reported by The Lancet, real change was seen at a pace that would previously have seemed impossible.

Why stop there? 

Ann Costello, Global Head of Roche Diagnostics Solutions | via Roche

The recommended WHO Resolution on strengthening diagnostics capacity represents an important step toward recognizing access to diagnostics as a policy priority as well as establishing concrete policy measures, to ensure equitable and timely access. It would pave the way for a considerable shift in strengthening our health care systems, driving progress toward global health equity and global health security.

As reported by the Lancet Commission[2], investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.

Early diagnosis is the cornerstone of sustainable, efficient and resilient health care systems. This in turn would reduce late-stage health care expenditures, including long-term costs of chronic disease management and disability, and better manage costs for patients, payors and governments. 

Increasing access to diagnostics is crucial to controlling and potentially even eradicating certain diseases like cervical cancer, HIV, tuberculosis, viral hepatitis and malaria.

Laboratories are an essential component of a sustainable, efficient and resilient health system. But only if there’s enough of them and trained staff to run them. 

The crux of the matter is that staff shortages in both high-income countries and low- and middle-income countries continue to create a barrier to diagnostic services. 

How short-staffed are we? Well, to put a number on it, an estimated shortage in diagnostic workforce capacity saw a need for an additional 480,000-576,000 staff to support diagnostic testing.[2] And who loses when we don’t have enough skilled laboratory professionals? Patients.

Investment in diagnostics such as improving laboratory infrastructure and workforce development must also be supported by smart local regulatory approaches. This will ensure that patients, regardless of where they live, have timely access to innovation and safe, effective diagnostics.

Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.

This can be through adherence to international best practices, such as those created by International Medical Device Regulators Forum and implementation of regulatory reliance models — where one regulatory body (or the WHO) relies on the decisions, such as marketing authorizations, inspections and product changes, already made by trusted authorities and recognized institutions.

Governments should prioritize expansion of professionals with expertise in pathology and laboratory medicine[3] and introduce laboratory personnel as a key component of workforce initiatives to address the needs of currently over-burdened health care systems. 

A new golden age for health care?

Roche is building partnerships to increase access to diagnostic solutions in low- and middle-income countries and to strengthen targeted laboratory systems through workforce training classes. In May 2022, Roche entered a partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure. The aim is building local capacity to tackle infrastructure challenges to improve diagnostic results and manage health care waste. This is in line with Roche’s ambition to double patient access to innovative, high-medical-value diagnostics for people around the world.

Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.

To achieve the golden age we need to learn from the past. All public and private stakeholders have a duty to work together to ensure diagnostics continue to improve health outcomes around the world by bringing this important resolution to life. 

Where a person lives should no longer be the key determining factor in their health. We have a tremendous opportunity here, let’s take it. 

[1] Accelerating diagnostic tests to prevent a future pandemic. Bill Rodriguez. Cepi. Available at: https://100days.cepi.net/100-days-mission-diagnostic-test-future-pandemic/ (Accessed 04.04.2023)

[2] The Lancet Commission on diagnostics: transforming access to diagnostics. Fleming, Kenneth A et al.The Lancet, Volume 398, Issue 10315, 1997 – 2050. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(21)00673-5.pdf

[3] https://www.ihe.net/ihe_domains/ihe_pathology_and_laboratory_medicine/ (Accessed: 04.04.2023)



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