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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

COVAX and World Bank to Accelerate Vaccine Access for Developing Countries

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COVAX and the World Bank will accelerate COVID-19 vaccine supply for developing countries through a new financing mechanism that builds on Gavi’s newly designed AMC cost-sharing arrangement. This allows AMC countries to purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.

COVAX will now be able to make advance purchases from vaccine manufacturers based on aggregated demand across countries, using financing from the World Bank and other multilateral development banks. Participating developing countries will have greater visibility of available vaccines, quantities available, and future delivery schedules, enabling them to secure doses earlier, and prepare and implement vaccination plans more effectively.

This important and timely financing mechanism, made possible now by the World Bank and Gavi teaming up on the AMC cost-sharing arrangement, will allow COVAX to unlock additional doses for low- and middle-income countries,” said Dr. Seth Berkley, CEO, Gavi, the Vaccine Alliance. “As we move beyond initial targets and work to support countries’ efforts to protect increasingly large portions of their populations, World Bank financing will help us advance further towards our goal of bringing COVID-19 under control.”

The scalable mechanism brings together COVAX’s ability to negotiate advance purchase agreements with vaccine manufacturers with the World Bank’s ability to provide predictable financing to countries for vaccine purchase, deployment and broader health systems investments. The new mechanism will mitigate risks and uncertainties in country demand and financing ability.

Accessing vaccines remains the single greatest challenge that developing countries face in protecting their people from the health, social, and economic impacts of the COVID-19 pandemic,” said World Bank Group President David Malpass. “This mechanism will enable new supplies and allow countries to speed up the purchase of vaccines. It will also provide transparency about vaccine availability, prices, and delivery schedules. This is crucial information as governments implement their vaccination plans.”

Countries with approved World Bank vaccine projects that confirm the purchase of additional doses through COVAX will agree with COVAX on the number of doses of a specific vaccine as well as related windows of delivery. On receiving a request from the country, the World Bank will provide COVAX a payment confirmation, allowing COVAX to make advance purchases of large amounts of vaccine doses with manufacturers at competitive prices.

Under the cost-sharing arrangement for AMC countries (92 low- and middle-income countries), COVAX plans to make available up to 430 million additional doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. There will be several supply offerings where countries will have the opportunity to select and commit to procuring specific vaccines that align with their preferences.

COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO). The World Bank and COVAX will work in partnership with UNICEF and the PAHO Revolving Fund as key implementing partners to ensure safe vaccine delivery and supply of materials such as syringes, safety boxes and other items essential for vaccination campaigns.

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Health & Wellness

Study Finds That India Might Have Half Of All Covid-19 Deaths Worldwide

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© UNICEF/Vinay

On July 20th, an analysis that was published of India’s “excess mortality estimates from three different data sources from the pandemic’s start through June 2021 … yields an estimate of 4.9 million excess deaths.” As-of July 20th, the total number of deaths that had been officially reported worldwide from Covid-19 was 4,115,391, and only 414,513 (10%) of those were in India. If this new study is correct, then the possibility exists that around half of all deaths that have occurred, thus far, from Covid-19, could be in India, not merely the currently existing 10% that’s shown in the official figures.

This study doesn’t discuss why the actual number of deaths in India from Covid-19 might be around ten times higher than the official Indian figures, but one reason might be a false attribution of India’s greatly increased death-rate from the Covid-19 epidemic not to Covid-19 but to other causes, such as to Covid-19-related illnesses.

The new study is titled “Three New Estimates of India’s All-Cause Excess Mortality during the COVID-19 Pandemic”, and the detailed version of it can be downloaded here.   The study was funded by U.S.-and-allied billionaires and their foundations and corporations, and by governments that those billionaires also might control. However, this doesn’t necessarily mean that its methodology is in any way unscientific or otherwise dubious. The study raises serious questions — it does not, in and of itself, answer any. It’s a serious scientific study.

On 1 August 2020, I headlined “India and Brazil Are Now the Global Worst Coronavirus Nations”, and reported that, “India and Brazil have now overtaken the United States as the world’s worst performers at controlling the cononavirus-19 plague. The chart of the numbers of daily new cases in India shows the daily count soaring more than in any other country except Brazil, whereas in the United States, the daily number of new cases has plateaued ever since it hit 72,278 on July 10th, three weeks ago.” At that time, there was great pressure upon India’s Government to stop the alarming acceleration in the daily numbers of people who were officially counted as being patients (active cases) from the disease, and of dying from it. One way that a government can deal with such pressures is by mis-classifying cases, and deaths, from a disease, as being due to other causes, instead.

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Sharp rise in Africa COVID-19 deaths

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A volunteer carer called Trinity is working in a COVID-19 field hospital in Nasrec, Johannesburg. IMF/James Oatway

COVID-19 deaths in Africa have risen sharply in recent weeks, amid the fastest surge in cases the continent has seen so far in the pandemic, the regional office for the World Health Organization (WHO) said on Thursday. 

Fatalities are rising as hospital admissions increase rapidly as countries face shortages in oxygen and intensive care beds. 

COVID-19 deaths rose by more than 40 per cent last week, reaching 6,273, or nearly 1,900 more than the previous week. 

The number is just shy of the 6,294 peak, recorded in January. 

Reaching ‘breaking point’ 

“Deaths have climbed steeply for the past five weeks. This is a clear warning sign that hospitals in the most impacted countries are reaching a breaking point,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.  

“Under-resourced health systems in countries are facing dire shortages of the health workers, supplies, equipment and infrastructure needed to provide care to severely ill COVID-19 patients.” 

Africa’s case fatality rate, which is the proportion of deaths among confirmed cases, stands at 2.6 per cent compared to the global average of 2.2 per cent.  

Most of the recent deaths, or 83 per cent, occurred in Namibia, South Africa, Tunisia, Uganda and Zambia. 

Six million cases 

COVID-19 cases on the continent have risen for eight consecutive weeks, topping six million on Tuesday, WHO reported. 

An additional one million cases were recorded over the past month, marking the shortest time to reach this grim milestone. Comparatively, it took roughly three months for cases to jump from four million to five million. 

Delta, variants drive surge 

The surge is being driven by public fatigue with key health measures and an increased spread of virus variants.  

The Delta variant, the most transmissible, has been detected in 21 countries, while the Alpha and Beta variants have been found in more than 30 countries each. 

Globally, there are four COVID-19 virus variants of concern.  On Wednesday, a WHO emergency committee meeting in Geneva warned of the “strong likelihood” of new and possibly more dangerous variants emerging and spreading. 

Delivering effective treatment

WHO is working with African countries to improve COVID-19 treatment and critical care capacities.  

The UN agency and partners are also delivering oxygen cylinders and other essential medical supplies, and have supported the manufacture and repair of oxygen production plants. 

“The number one priority for African countries is boosting oxygen production to give critically ill patients a fighting chance,” Dr Moeti said. “Effective treatment is the last line of defence against COVID-19 and it must not crumble.” 

The rising caseload comes amid inadequate vaccine supplies. So far, 52 million people in Africa have been inoculated, which is just 1.6 per cent of total COVID-19 vaccinations worldwide.  

Meanwhile, roughly 1.5 per cent of the continent’s population, or 18 million people, are fully vaccinated, compared with over 50 per cent in some high-income countries. 

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