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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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WHO chief warns against ‘catastrophic moral failure’ in COVID-19 vaccine access

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A “me-first approach” to COVID-19 vaccines on the part of some countries and manufacturers is putting equitable access to these lifesaving treatments at risk, the head of the World Health Organization (WHO) warned on Monday. 

Addressing the agency’s Executive Board, WHO chief Tedros Adhanom Ghebreyesus expressed fear that “even as vaccines bring hope to some, they become another brick in the wall of inequality between the world’s haves and have-nots.” 

Describing the rapid development of vaccines as a literal and figurative “shot in the arm” during the pandemic, Tedros reported that while 39 million doses have been administered in nearly 50 richer countries, only 25 have been given in one lowest income nation. 

A self-defeating approach  

“I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries”, he said, speaking from WHO headquarters in Geneva. 

Ensuring all countries will have access to any COVID-19 vaccines is the promise of a global mechanism established last April, known as the COVAX Facility. It has secured two billion doses so far, with a billion more in the pipeline, and deliveries should begin next month. 

“Even as they speak the language of equitable access, some countries and companies continue to prioritize bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue. This is wrong”, Tedros stated. 

Additionally, most manufacturers also have prioritized regulatory approval in rich countries, where profits are higher, rather than submitting their dossiers to WHO for prequalification. 

“This could delay COVAX deliveries and create exactly the scenario COVAX was designed to avoid, with hoarding, a chaotic market, an uncoordinated response, and continued social and economic disruption”, he said. 

“Not only does this me-first approach leave the world’s poorest and most vulnerable people at risk, it’s also self-defeating.” 

Change the rules of the game 

Underlining that vaccine equity also has economic benefits, Tedros urged countries to “work together in solidarity” to ensure inoculation of all health workers and older people at most risk worldwide is underway, within the first 100 days of the year. 

He pressed for action in three areas to “change the rules of the game”, starting with an appeal for transparency in any bilateral contracts between countries and COVAX, including on volumes, pricing and delivery dates. 

“We call on these countries to give much greater priority to COVAX’s place in the queue, and to share their own doses with COVAX, especially once they have vaccinated their own health workers and older populations, so that other countries can do the same”, he said. 

Tedros also called for vaccine producers to provide WHO with full data for regulatory review in real time, to accelerate approvals, and he urged countries to only use vaccines that have met international safety standards, and to accelerate readiness for their deployment.  

“My challenge to all Member States is to ensure that by the time World Health Day arrives on the 7th of April, COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health challenges”, he said, adding, “I hope this will be realized.” 

‘Vaccinationalism’ threatens recovery: UN chief

UN Secretary-General António Guterres has again stressed that COVID-19 vaccines must be a global public good, available to everyone, everywhere. 

Speaking in New York at a ceremony for the world’s developing nations, he underlined the need for funding for medicines and diagnostics to defeat the virus. 

“We need manufacturers to step up their commitment to work with the COVAX facility and countries around the world, in particular the world’s leading economies, to ensure enough supply and fair distribution,” said Mr. Guterres. 

“‘Vaccinationalism’ is self-defeating and would delay a global recovery.” 

The Secretary-General said recovery also represents a chance to “change course”, away from the old “normal” of inequalities and injustices, and he continues to advocate for greater support from developed countries and international financial institutions. 

“With smart policies and the right investments, we can chart a path that brings health to all, revives economies and builds resilience,” he said. “But developing countries must have the necessary resources to do so.”

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UN agencies supporting mammoth India COVID-19 vaccine rollout

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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

India has begun what is the world’s biggest COVID vaccination campaign so far, deploying hundreds of thousands of health workers, with the training and support of the UN World Health Organization (WHO). 

On 16 January, the first day of the campaign, 207,229 vaccine shots were given across the country, one of the worst-hit by COVID-19, with over 10 million COVID-19 infections and 150,000 deaths. 

“[We] provided technical assistance to the Government of India for the development of operational guidelines and other training materials for state and district programme managers and vaccinators, and establishing tracking and accountability frameworks”, Roderico H. Ofrin, WHO Representative in India said. 

“WHO field officers have facilitated the highest-level oversight through regular task force meetings at state and district levels, which are chaired by the Principal Secretaries (Health) at the state level, and District Magistrates at the district level”, he added. 

According to media reports, an estimated 10 million health workers are targeted to be vaccinated in the first round, followed by other front-line workers such as police, security forces and municipal staff, with plans to inoculate 300 million people by August. 

Supporting preparations 

Prior to the start of the campaign, UN agencies help with detailed preparations. 

For its part, WHO participated in dry-run simulations and provided feedback on management of vaccines, registration of beneficiaries, as well as reporting on vaccination coverage and adverse events following immunization. 

It also worked with the Government and the UN Development Programme (UNDP) on real-time reporting and problem-solving when issues arose at the vaccination sites, according to Dr. Ofrin. 

At the provincial level, WHO also supported implementation and monitoring of health policy, such as developing standard operating procedures, preparing technical briefs, and providing best practices from other parts of the India as well as other countries. 

Reliable information 

Similarly, the UN Children’s Fund (UNICEF) supported communication and advocacy efforts to ensure the dissemination of factual information to stakeholders and communities. The agency also helped train healthcare staff in infection control and prevention, and psychosocial support to children and caregivers.  

Aside from directly supporting vaccine rollout, UN agencies continued their programmes to assist the most vulnerable communities impacted by COVID-19 and its socio-economic fallouts.  

For instance, the UN World Food Programme (WFP) supported NGOs in order to identify and register some 19,000 vulnerable households and distributed food packets; while the UN Population Fund (UNFPA) conducted awareness raising programmes on sexual and reproductive health, and prevention of gender-based violence, on behalf of some 30 million vulnerable individuals.  

The three W’s  

Though vaccination programmes are underway, continued vigilance against COVID-19 and preventing its spread remain as important as ever. 

WHO’s Dr. Ofrin urged continued vigilance over tracking cases, cluster investigation, isolation and clinical care, and quarantining to break the chain of transmission. 

Alongside, he also highlighted the “three W’s – wear a mask, wash your hands and watch your distance.” 

“These efforts must continue to stop the spread of COVID-19. We as individuals and communities must work with the Government to save lives and the economy by protecting health and livelihoods,” he added.

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Independent panel finds critical early failings in COVID-19 response

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The global system for pandemic alert and response is “not fit for purpose”, highlighting the need for a new framework in the wake of COVID-19, experts appointed by the World Health Organization (WHO) said in an interim report presented on Tuesday. 

The Independent Panel for Pandemic Preparedness and Response found critical elements to be “slow, cumbersome and indecisive” in an era when information about new disease outbreaks is being transmitted faster than countries can formally report on them. 

“When there is a potential health threat, countries and the World Health Organization must further use the 21st century digital tools at their disposal to keep pace with news that spreads instantly on social media and infectious pathogens that spread rapidly through travel”, said Helen Clark, former Prime Minister of New Zealand and co-chair of the panel.   

“Detection and alert may have been speedy by the standards of earlier novel pathogens, but viruses move in minutes and hours, rather than in days and weeks.”  

‘Lost opportunities’ at the outset 

The Independent Panel was established to review lessons learned from international response to COVID-19, which first emerged in Wuhan, China, in December 2019. Nearly 94 million confirmed cases and more than two million deaths have been reported globally as of Tuesday. 

The panel’s second progress report said countries were slow to respond to the new coronavirus disease, noting “there were lost opportunities to apply basic public health measures at the earliest opportunity”. 

Although WHO declared on 30 January 2020 that COVID-19 was a Public Health Emergency of International Concern (PHEIC), the panel found many countries took minimal action to prevent spread both within and beyond their borders. 

“What is clear to the Panel is that public health measures could have been applied more forcefully by local and national health authorities in China in January”, the report said.  

“It is also clear to the Panel that there was evidence of cases in a number of countries by the end of January 2020. Public health containment measures should have been implemented immediately in any country with a likely case. They were not.” 

The report also outlined critical shortcomings at each phase of response, including failure to prepare for a pandemic despite years of warning.  

“The sheer toll of this epidemic is prima facie evidence that the world was not prepared for an infectious disease outbreak with global pandemic potential, despite the numerous warnings issued that such an event was probable”, it said. 

Deepening inequalities 

Pandemic response has also deepened inequalities, according to the panel, with inequitable access to COVID-19 vaccines a glaring example as rollout has favoured wealthy nations. 

“A world where high-income countries receive universal coverage while low-income countries are expected to accept only 20 per cent in the foreseeable future is on the wrong footing – both for justice and for pandemic control. This failure must be remedied”, said the panel’s co chair, Ellen Johnson Sirleaf, former President of Liberia. 

The report further highlighted the need to strengthen the UN’s health agency. 

“The WHO is expected to validate reports of disease outbreaks for their pandemic potential and, deploy support and containment resources, but its powers and funding to carry out its functions are limited”, Ms. Sirleaf said. “This is a question of resources, tools, access, and authority.”   

Countries are also urged to ensure testing, contact tracing and other public health measures to reduce virus spread, are being implemented, in efforts to save lives, particularly as more infectious virus variants emerge. 

The Independent Panel began its review last September and will present a report to the World Health Assembly, the decision-making body of WHO, in May.

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