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Pharmaceutical Strategy for Europe: Affordable, accessible and safe medicines for all

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The Commission has today adopted a Pharmaceutical Strategy for Europe to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. A key component of building a stronger European Health Union, as called for by President von der Leyen in her State of the Union Speech, the Strategy will help to establish a future-proof and crisis-resilient EU pharmaceutical system.

Europe’s Pharmaceutical Strategy has four main objectives:

  • Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
  • Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines
  • Enhancing crisis preparedness and response mechanisms, and addressing security of supply;
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

Although the Strategy is much more than a crisis-response instrument, it draws lessons from the initial response to the COVID-19 pandemic, and makes Europe’s pharmaceutical sector better prepared and more resilient.

The Strategy presents concrete actions to ensure accessibility, availability and affordability of medicines. It supports diversified and secure supply chains, ensuring the EU’s open strategic autonomy in the world, and it promotes environmentally sustainable pharmaceuticals.

The Strategy will also ensure that the EU’s pharmaceutical policy continues to serve public health in an ever-changing environment of scientific and commercial transformations. It will support patient centred innovations and accommodate digital and technological change.

Members of the College said

President of the European Commission, Ursula von der Leyen, stated: “The coronavirus pandemic has highlighted the vital need to strengthen our health systems. This includes access to safe, effective and high-quality medicines at an affordable price.  In the challenging economic and social times the EU is currently facing, the strategy adopted today will ensure that Europe and Europeans will continue to benefit from such medicines. I call on Member States and the Parliament to endorse this approach which will be rolled out in the next three years, and beyond.”

Vice-President for Promoting the European Way of Life, Margaritis Schinas, said: “Effective and safe medicines, vaccines and treatments have helped to tackle some of the leading causes of disease and life-threatening illnesses in the past. These products will be crucial to uphold the health and well-being of the European citizens in these challenging times. Today’s strategy supports the EU’s pharmaceutical industry to remain competitive and innovative, whilst addressing the needs of the patients and those of our health systems.”

Stella Kyriakides, Commissioner for Health and Food Safety, stressed: “Today we launch the work to ensure that safe and effective medicines are accessible and affordable at all times and to all patients across the EU. With our Pharmaceutical Strategy for Europe, we are delivering on our commitment to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish and continue to be a global leader. It is our long-term vision for open strategic autonomy, and our response to the challenges of today and the vulnerabilities exposed by COVID-19. Today we put in place another pillar of the European Health Union.”

Background

The Pharmaceutical Strategy for Europe marks the beginning of a process: its implementation includes an ambitious agenda of legislative and non-legislative actions which will be launched over the coming years.  

Actions will cover the whole ecosystem of pharmaceuticals, but also some aspects of medical devices. It creates synergies with the Green Deal and our actions under the EU Strategic approach of pharmaceuticals in the environment to reduce their environmental risk, address pollution from pharmaceutical residues and promote greener manufacturing, use and disposal (a progress report is available). It is also linked to the action plan on Intellectual Property presented today.  

The flagship actions of the Strategy include:

  • A revision of the basic pharmaceutical legislation* (target date for a proposal: 2022) with a view to making this framework future-proof and innovation friendly;
  • A proposal for a EU Health Emergency Response Authority (proposal: 2nd semester 2021);
  • A revision of the regulations on medicines for children and rare diseases
  • Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU;
  • Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system’s sustainability;
  • The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for a proposal: 2021);
  • Support to research and innovation, notably via Horizon 2020 and EU4Health;
  • Actions to promote innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives and measures to restrict and optimise their use.

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Health & Wellness

COVID vaccines: Widening inequality and millions vulnerable

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Health leaders agree that a world without COVID-19 will not be possible until everyone has equal access to vaccines. More than 4.6 million people have died from the virus since it swept across the globe from the beginning of 2020, but it’s expected that the rate of people dying will slow if more people are vaccinated. 

Developed countries are far more likely to vaccinate their citizens, which risks prolonging the pandemic, and widening global inequality. Ahead of a dialogue at the UN on Monday between senior United Nations officials UN News explains the importance of vaccine equity.

What is vaccine equity?

Quite simply, it means that all people, wherever they are in the world, should have equal access to a vaccine which offers protection against the COVID-19 infection.

WHO has set a global target of 70 per cent of the population of all countries to be vaccinated by mid-2022, but to reach this goal a more equitable access to vaccines will be needed.

Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO) said vaccine equity was “not rocket science, nor charity. It is smart public health and in everyone’s best interest.”

Why is it so important?

Apart from the ethical argument that no country or citizen is more deserving of another, no matter how rich or poor, an infectious disease like COVID-19 will remain a threat globally, as long as it exists anywhere in the world.

Inequitable vaccine distribution is not only leaving millions or billions of people vulnerable to the deadly virus, it is also allowing even more deadly variants to emerge and spread across the globe.

Moreover, an unequal distribution of vaccines will deepen inequality and exaggerate the gap between rich and poor and will reverse decades of hard-won progress on human development.

According to the UN, vaccine inequity will have a lasting impact on socio-economic recovery in low and lower-middle income countries and set back progress on the Sustainable Development Goals (SDGs). According to the UNDP, eight out of ten people pushed into poverty directly by the pandemic are projected to live in the world’s poorest countries in 2030.

Estimates also suggest that the economic impacts of COVID-19 may last until 2024 in low-income countries, while high-income countries could reach pre-COVID-19 per capita GDP growth rates by the end of this year.

Is it working?

Not according to Dr Tedros, who said in April this year that “vaccine equity is the challenge of our time…and we are failing”.

Research suggests that enough vaccines will be produced in 2021 to cover 70 per cent of the global population of 7.8 billion. However, most vaccines are being reserved for wealthy countries, while other vaccine-producing countries are restricting the export of doses so they can ensure that their own citizens get vaccinated first, an approach which has been dubbed “vaccine nationalism”. The decision by some nations to give already inoculated citizens a booster vaccine, rather than prioritizing doses for unvaccinated people in poorer countries has been highlighted as one example of this trend.

 Still, the good news, according to WHO data, is that as of September 15, more than 5.5 billion doses have been administered worldwide, although given that most of the available vaccines require two shots, the number of people who are protected is much lower.

Which countries are getting the vaccines right now?

Put simply, the rich countries are getting the majority of vaccines, with many poorer countries struggling to vaccinate even a small number of citizens.

According to the Global Dashboard for Vaccine Equity  (established by UNDP, WHO and Oxford University) as of September 15, just 3.07 per cent of people in low-income countries have been vaccinated with at least one dose, compared to 60.18 per cent in high-income countries.

The vaccination rate in the UK of people who have received at least one vaccine dose is around 70.92 per cent while the US is currently at 65.2 per cent. Other high-income and middle-income countries are not doing so well; New Zealand has vaccinated just 31.97 per cent of its relatively small population of around five million, although Brazil, is now at 63.31 per cent.

However, the stats in some of the poorest countries in the world make for grim reading. In the Democratic Republic of the Congo just 0.09 per cent of the population have received one dose; in Papua New Guinea and Venezuela, the rate is 1.15 per cent and 20.45 per cent respectively.

What’s the cost of a vaccine?

Data from UNICEF show that the average cost of a COVID-19 vaccine is $2 to $37 (there are 24 vaccines which have been approved by at least one national regulatory authority) and the estimated distribution cost per person is $3.70. This represents a significant financial burden for low-income countries, where, according to UNDP, the average annual per capita health expenditure amounts to $41.

The vaccine equity dashboard shows that, without immediate global financial support, low-income countries would have to increase their healthcare spending by between 30 and 60 per cent to meet the target of vaccinating 70 per cent of their citizens.

What has the UN been doing to promote a more equitable access to vaccines?

WHO and UNICEF have worked with other organizations to establish and manage the COVID-19 Vaccine Global Access Facility, known as COVAX. Launched in April 2020, WHO called it a “ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines”.

Its aim is to guarantee fair and equitable access for every country in the world based on need and not purchasing power.

Currently, COVAX numbers 141 participants according to the UN-supported Gavi alliance, but it’s not the only way that countries can access vaccines as they can also make bilateral deals with manufacturers.

Will equal access to vaccines bring an end to the pandemic?

It’s a crucial step, obviously, and in many richer countries, life is getting back to some sort of normality for many people, even if some pandemic protocols are still in place. The situation in less developed countries is more challenging. While the delivery of vaccines, provided under the COVAX Facility, is being welcomed across the world, weak health systems, including shortages of health workers are contributing to mounting access and distribution challenges on the ground.

And equity issues don’t disappear once vaccines are physically delivered in country; in some nations, both rich and poor, inequities in distribution may still persist.

It’s also worth remembering that the imperative of providing equal access to health care is, of course, not a new issue, but central to the Sustainable Development Goals and more precisely, SDG 3 on good health and well-being, which calls for achieving universal health coverage and affordable essential medicines and vaccines for all.

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Health & Wellness

Moderna vs. Pfizer: Two Recent Studies Show Moderna to Be The More Effective One

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The first study was published by medRxiv “The Preprint Server for Health Sciences” on August 9th, and compared (on 25,589 vaccinated v. 25,589 unvaccinated Minnesotans) “the effectiveness of two full-length Spike protein-encoding mRNA vaccines from Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b2) in the Mayo Clinic Health System in Minnesota over time from January to July 2021.” Moderna was 86% effective against the infection; Pfizer was 76% effective. In July (when the “Delta” variant first became dominant) Moderna was 91.6% effective against hospitalization; Pfizer was 85%. But during that month, effectiveness against the infection was 76% for Moderna v. 42% for Pfizer. Nationwide (including Mayo in MN, WI, AZ, FL, & IA), Moderna was about twice as effective “against breakthrough infection” v. Pfizer.

The second study was far smaller, published on September 10th by the CDC, and studied only 1,175 hospitalized U.S. veterans (93% male) at V.A. centers nationwide. Moderna was estimated at 91.6% effective, Pfizer at 83.4%. Since no non-hospitalized comparison-sample were studied, “Vaccine effectiveness … to prevent Covid-19-associated hospitalization was estimated by using multivariate logistic regression to compare the odds of full vaccination between case-patients and controls,” and so the reliability of this study was far less than in the Mayo Clinic study.

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India Completes First Drone Delivery of Vaccines

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Health workers pose with a vial of COVID-19 vaccine after receiving their shots at a hospital in India. UNICEF/Vinay Panjwani

Today marks the beginning of the first trials for the delivery of MMR, influenza and COVID-19 vaccines in the southern state of Telangana.

The trials, which have been organized by the World Economic Forum in partnership with the state government of Telangana, Apollo Hospital’s HealthNet Global and NITI Aayog, will be conducted over 28 days in designated air corridors in the district of Vikarabad, Telangana.

Starting off with the first ever drone delivery of a vaccine in India, the trials are focused on laying the groundwork for a more elaborate drone delivery network that will improve access to vital healthcare supplies for remote and vulnerable communities. This is also the first drone programme since India recently liberalized its drone policy.

“The Forum is pleased to support Indian government and industry in demonstrating how emerging technologies can be used to improve access to healthcare for its most vulnerable populations,” says Timothy Reuter, Head of Aerospace and Drones, World Economic Forum. “The project has set into motion the adoption of drones to deliver lifesaving services across the country. We believe that India’s work with drones can serve as a model for other countries in the region and beyond.”

“Ever since Telangana issued the expression of interest in expanded drone use in March 2020, the industry has witnessed an acceleration around policy decisions,” said Vignesh Santhanam, Lead, Aerospace and Drones, World Economic Forum. “With the latest liberalization of India’s drone economy the Medicine from the Sky initiative has made efforts to invigorate the drone sector in India by demonstrating the essence of cooperative federalism and creating a template for the region.”

“Being at the forefront of leveraging emerging technologies, Telangana has always acted as a testbed for innovative solutions to support scaling across the nation,” said K.T. Rama Rao, Minister of Information Technology, Industries, Municipal Administration and Urban Development of Telangana, India. “The COVID-19 pandemic has highlighted that healthcare supply chains can be further strengthened and drones offer a robust value proposition especially when it comes to remote areas and emergencies. The Medicine from the Sky is the first of its kind initiative in the country to generate insights that shall benefit the entire ecosystem. The enthusiasm and support by all the partners is deeply appreciated.”

With the support of the Vikarabad municipality, India’s Ministry of Civil Aviation, the Directorate-General of Civil Aviation and the Airports Authority of India, this will be the first drone-delivered COVID-19 vaccine in Asia. After extended trials with MMR and influenza vaccines, COVID-19 vaccines will also be transported beyond the visual line of sight.

“This pilot has been enabled through a series of collaborations between India’s regulatory agencies state government, the World Economic Forum, international organizations, healthcare experts and drone companies,” said Anna Roy, Senior Adviser, Frontier Technologies, NITI Aayog, Government of India. “The Medicine from the Sky community has acted as an important platform providing advice and insight that has translated the extensive academic groundwork into action on ground. Through a highly collaborative effort, the pilot programme also demonstrates the importance of localized inputs and micro planning for healthcare in remote parts of the world.”

This initiative aims to improve equity in healthcare while enabling healthcare access for isolated populations and hazard-prone areas. The project has eight participating partners, including drone operators and experts in healthcare and airspace management among others. Together, these partners will demonstrate short and long-range drone-based deliveries to assess the efficacy of low-altitude aerial logistics in healthcare.

“Drone use provides the opportunity to support our traditional approaches to healthcare delivery especially in underserved or remote regions of the country,” said Dr. Sangita Reddy, Joint Managing Director, Apollo Hospitals Group. “Our healthcare sector could potentially witness large-scale deliveries of long-tail medicines, vaccines, blood and vital organs throughout the country across terrains with drones in action. As clinical partners in the Medicine from the Sky initiative, Apollo Hospital’s HealthNet Global will be responsible for enabling vaccine and medicine availability and properly monitoring the adherence of clinical protocols throughout the project.”

An industry core group was commissioned in June 2021 to help scale the effort to bolster last-mile mobility in healthcare. The outcomes from the trials will be analysed and used to scale up the effort to additional states with the support of the Medicine from the Sky community and key stakeholders. The project is expected to be expanded to six states in the coming months.

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