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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

Stockholm+50: Accelerate action towards a healthy and prosperous planet for all

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The United Nations General Assembly agreed on the way forward for plans to host an international meeting at the highest possible level in Stockholm next June, during the week of World Environment Day. The event will commemorate the 50 years since the United Nations Conference on the Human Environment and serve as a contribution to accelerate action towards a more sustainable society.

The Declaration of the United Nations Conference on the Human Environment was made in 1972 in Stockholm, Sweden, resulting in what is often seen as the the first step toward the development of international environmental law, recognizing the importance of a healthy environment for people, and creating the UN Environment Programme (UNEP).

Five decades after the 1972 Stockholm Conference, the Government of Sweden, with support from the Government of Kenya, will host Stockholm+50, an international meeting in 2022 to commemorate the 50 years since the United Nations Conference on the Human Environment and its outcome documents, as a contribution to the environmental dimension of sustainable development to accelerate the implementation of commitments in the context of the decade of action and delivery for sustainable development, including a sustainable recovery from the coronavirus disease (COVID-19) pandemic.

The international meeting, “Stockholm+50: a healthy planet for the prosperity of all – our responsibility, our opportunity”, will take place in Stockholm on 2 and 3 June 2022, following a UN General Assembly resolution. In three leadership dialogues, the meeting will reflect on the urgent need for actions towards a healthy planet and prosperity of all, achieving a sustainable and inclusive recovery from the COVID-19 pandemic, and accelerating the implementation of the environmental dimension of Sustainable Development in the context of the Decade of Action. The meeting will also reinforce the messages and the outcomes of the event to commemorate UNEP’s 50th anniversary (UNEP@50), which will have taken place in March 2022, in Nairobi.

Per Bolund, Sweden’s Minister for the Environment and Climate, and Deputy Prime Minister, said “Our aim is clear, we want Stockholm+50 to make a concrete contribution to accelerating the transformation to a sustainable future. We call this meeting to commemorate the fiftieth anniversary of the 1972 conference. We are running out of time and urgent action is needed. These challenges are global, and we must meet them with a global response that drives action on the ground.”

Inger Andersen, Executive Director of UNEP, who was on 11 October appointed by UN Secretary-General António Guterres as the Secretary-General of the Stockholm+50 international meeting, said: “We need to urgently work to transform our economies and societies, but our branches will spread only as far as our roots are deep. By remembering Stockholm at 50, we also remember how the world came together to heal the ozone layer in 2013, phase out leaded fuel this year and stop endangered species from going extinct. By convening in Stockholm, we also recommit to human and planetary health, responsibility, prosperity, equality and peace – as we have seen only too clearly in COVID-19.”

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COVID-19 deaths at lowest level in nearly a year

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A thermometer gun is used to take a boy's temperature in Sri Lanka. © UNICEF/Chameera Laknath

Although COVID-19 deaths continue to decline, vaccine inequity persists, the head of the World Health Organization (WHO) said on Wednesday, again calling for greater support for developing countries.

Agency chief Tedros Adhanom Ghebreyesus reported that the death toll from the disease is now at its lowest level in almost a year. 

“But it’s still an unacceptably high level – almost 50,000 deaths a week, and the real number is certainly higher,” he said, speaking during the regular WHO briefing from Geneva. 

“Deaths are declining in every region except Europe, where several countries are facing fresh waves of cases and deaths.  And of course, deaths are highest in the countries and populations with the least access to vaccines.” 

Tedros appealed for global cooperation. “Countries that continue to roll out boosters now are effectively preventing other countries from vaccinating their most at-risk populations,” he said. 

Missing the mark 

As of Wednesday, there were more than 238 million COVID-19 cases worldwide, and more than 4.8 million deaths. 

WHO had previously pushed governments to vaccinate 10 per cent of their populations by the end of September, a target which 56 nations missed, most of them in Africa. 

Tedros said even more countries are at risk of missing the 40 per cent target to be achieved by the end of the year.  Three countries – Burundi, Eritrea and the Democratic People’s Republic of Korea – have yet to start vaccinations. 

 “About half of the remaining countries are constrained by supply. They have a vaccination programme underway, but don’t have enough supply to accelerate enough to reach the target,” he said. 

Tedros urged countries and companies that control global vaccine supply to prioritize distribution to the COVAX solidarity initiative and the African Vaccine Acquisition Trust (AVAT). 

Meanwhile, WHO and partners are working with other countries, such as those affected by fragility or conflict, to strengthen technical and logistical capacity for vaccine rollout. 

“With aggressive and ambitious action, most of these countries can still reach the 40% target by the end of this year, or be on a clear pathway to reaching it.” 

Crisis in Tigray 

Tedros also addressed the escalating crisis in northern Ethiopia, where a nearly year-long war in the Tigray region has left up to seven million people in urgent need for food and other assistance. 

The conflict has spilled over into neighbouring Afar and Amhara, further increasing needs and complicating response efforts. Aid is not reaching the area “at anywhere close to the levels needed”, he said, and communications, electricity, other basis services remain cut off. 

WHO and partners are calling for unfettered access to the affected regions, as the lives of millions of people are at stake, Tedros told journalists. 

“People with chronic illnesses are dying due to lack of both food and medicine. Nearly 200,000 children have gone without critical vaccinations,” he said   

“When people do not have enough food, they are more susceptible to deadly diseases, as well as the threat of starvation, and that’s what we’re now seeing in Tigray.”

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Global health community prescribes climate action for COVID recovery

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Street scene in India. © UNICEF/Vinay Panjwani

Ambitious national climate commitments are crucial for States to sustain a healthy, green recovery from the COVID-19 pandemic, according to a new UN health agency report launched on Monday in the lead-up to the COP26 climate change conference in Glasgow, Scotland.

Based on a growing body of research confirming numerous and inseparable links between climate and health, the World Health Organization’s (WHO) COP26 Special Report on Climate Change and Health spells out that transformational action in every sector, from energy, transport and nature to food systems and finance is needed to protect people.

The COVID-19 pandemic has shone a light on the intimate and delicate links between humans, animals and our environment”, said WHO chief Tedros Adhanom Ghebreyesus. “The same unsustainable choices that are killing our planet are killing people”.

An urgent call

WHO’s report was launched at the same time as an open letter, signed by over two thirds of the global health workforce – 300 organizations representing at least 45 million doctors and health professionals worldwide – calling for national leaders and COP26 country delegations to step up climate action. 

“Wherever we deliver care, in our hospitals, clinics and communities around the world, we are already responding to the health harms caused by climate change”, the letter from the health professionals reads.

“We call on the leaders of every country and their representatives at COP26 to avert the impending health catastrophe by limiting global warming to 1.5°C, and to make human health and equity central to all climate change mitigation and adaptation actions”.

Fossil fuels ‘killing us’

Both the report and open letter come as unprecedented extreme weather events and other climate impacts are taking a rising toll on everyone.

Heatwaves, storms and floods have taken thousands of lives and disrupted millions of others while also threatening healthcare systems and facilities when they are needed most, according to WHO.

Changes in weather and climate are threatening food security and driving up food-, water- and vector-borne diseases, such as malaria, while climate impacts are also negatively affecting mental health.  

“The burning of fossil fuels is killing us. Climate change is the single biggest health threat facing humanity”, states the WHO report. And while no one is safe from the health impacts of climate change, “they are disproportionately felt by the most vulnerable and disadvantaged”.

Climate actions far outweigh costs

Meanwhile, air pollution, primarily the result of burning fossil fuels, which also drives climate change, causes 13 deaths per minute worldwide, according to WHO. 

The report states clearly that the public health benefits from implementing ambitious climate actions far outweigh the costs. 

“It has never been clearer that the climate crisis is one of the most urgent health emergencies we all face”, said Maria Neira, WHO Director of Environment, Climate Change and Health.

“Bringing down air pollution…would reduce the total number of global deaths from air pollution by 80 per cent while dramatically reducing the greenhouse gas emissions that fuel climate change”, she pointed out.

Dr. Neira added that a shift to more nutritious, plant-based diets “could reduce global emissions significantly, ensure more resilient food systems, and avoid up to 5.1 million diet-related deaths a year by 2050”.  

Call to action

Although achieving the Paris Agreement on climate change would improve air quality, diet and physical activity – saving millions of lives a year – most climate decision-making processes currently do not account for these health co-benefits and their economic valuation.  

Tedros underscored WHO’s call for all countries to “commit to decisive action at COP26 to limit global warming to 1.5°C – not just because it’s the right thing to do, but because it’s in our own interests”, and highlighted 10 priorities in the report to safeguard “the health of people and the planet that sustains us.”

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