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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

WHO approves Chinese COVID-19 vaccine for emergency use

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A COVID-19 vaccine produced in China has been given the green light for global rollout, potentially paving the way for its use in underserved countries, the World Health Organization (WHO) announced on Friday. 

The UN agency has approved the Sinopharm vaccine for emergency use, which is a prerequisite for inclusion in the global vaccine solidarity initiative, COVAX.  

The vaccine is easy to store, making it suitable for locations with limited resources, and proved 79 per cent effective in clinical trials. 

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk”, said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.  

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.” 

A vaccine first 

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG).   

It is the first vaccine to carry a vaccine vial monitor. The vials have a small sticker that changes colour as the vaccine is exposed to heat, so health workers know whether it can be safely used. 

The vaccine is recommended for adults 18 and older, with a two-dose schedule spaced over a period of three to four weeks. 

Although few people over 60 participated in the clinical trials, WHO did not recommend an upper age limit for use as data suggests the vaccine is likely to have a protective effect in older persons.   

Safely expediting vaccines 

WHO emergency use listing (EUL) allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. 

The EUL process assesses the suitability of new medicines, vaccines and diagnostics during public health emergencies.  

The goal is to make them available as rapidly as possible, while maintaining strict criteria of safety, efficacy and quality. 

The Sinopharm vaccine is the sixth to receive the EUL approval.  The others are by Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen (Johnson & Johnson) and Moderna.

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Risky business: COVID-19 and safety at work

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Photo: UN Women Asia-Pacific

The numbers of home workers around the world  have been swelled by the COVID-19 pandemic, putting a fresh focus on the need for employers to ensure that their employees are working in a safe environment. On the World Day for Safety and Health at Work, we look at some of the ways the UN is helping employers and governments to keep people safe, wherever they work.

The world of work has been upended by COVID-19, and the effects are likely to be long-lasting. Before the pandemic, there were some 260 million home-based workers (not including domestic or care workers). The International Labour Organisation (ILO) estimates that figure could have doubled, with as many as one in three workers remote working in North America and Europe, and one in six in sub-Saharan Africa.

The rollout of vaccines, mainly in the developed world,  has increased the possibilities of a return to the workplace, but many companies and workers have signalled a wish to retain a degree of home working, after seeing some of the benefits. For employers, these include minimising the risk of contagion and  potentially spending less on expensive office space whilst staff no longer have to spend commuting to and from the workplace.

‘If you’re losing your mind, I’m right there with you’

However, whilst some are enjoying baking bread or taking a stroll during a conference call, and using the commuting time to indulge in new pursuits, others have been craving a return to a more structured work-life routine.

“I tell myself daily that I am grateful to have a job with understanding supervisors and colleagues. But all of it is hard. If you’re also a working mum losing her mind daily, know that I’m right there with you,” says Paulina, a New York-based teleworker.

“I have chaired meetings with a laptop and headphones on one side of a tiny, New York City kitchen while cooking lunch and having a screaming toddler wrapped around my ankles. While all of this is cute once or maybe twice, regular screams of children in the background can only be tolerated for so long. I should know, because I passed that line sometime in July.”

Stories such as this explain why a recent study by the International Labour Organisation (ILO) found that 41 per cent of people who worked from home considered themselves highly stressed, compared to 25 per cent of those who worked on-site.

“The most effective way to eliminate the risk of contagion in a work context is, for those who can do it, teleworking, says Joaquim Nunes, head of occupational health and safety at the ILO, “But we still need to pay attention to the physical and mental well-being of workers”.

As teleworking is likely to remain an important factor in many people’s jobs, Mr. Nunes says that work-related policies will have to be updated to reflect the new reality.

“There’s a good chance that the rise of teleworking during the COVID-19 pandemic will permanently change how we live and work. Many governments have realised this, and are taking a fresh look at the rights of employees working from home. For example, companies should ensure that workers do not feel isolated, whilst giving them the right to disconnect, rather than being online 24 hours a day”.

In Chile, a law adopted early in March 2020 goes some way to addressing some of these concerns. The legislation recognizes the right of remote workers to disconnect for at least 12 continuous hours in a 24-hour period. In addition, employers cannot require workers to respond to communications on rest days or holidays.

A healthy home?

Beyond the question of comfort and mental health, is one of physical safety. It is often said that most accidents happen at home, so, if this is where much of the working week is spent, should employers be responsible for making sure apartments aren’t death traps?

“For now, there are no easy answers when it comes to ensuring a suitable home office environment”, says Mr. Nunes. “However, we can say that the same principles that apply to other workplaces apply to teleworkers, in that employers have a general duty of care, as reasonably practicable. Employers can’t control the workplace when staff are working from home, but they can provide ergonomic equipment to workers, such as suitable chairs, and help them to assess their own risks and to learn about how to maintain healthy lifestyles.”

Teleworking is also challenging for enforcement agencies, as usually inspectors do not have free access to the private spaces. One solution to ensure compliance with legislation could be virtual inspections, which are already taking place in Nordic countries on a voluntary basis. “These involve labour inspectors video calling a worker at home, and being shown their work chair, desk, and lighting setup”, explains Mr. Nunes. “These inspections can serve as a way to monitor the home workplace and provide advice, but also raise understandable privacy concerns”.

Frontline fears

Whilst the new teleworkers and their employers grappled with their new reality, a large part of the global workforce had no choice but to go to a physical place of work. The difficulties faced by health care workers were widely reported, but employees in several other industries had to brave the trip to the workplace – sometimes on crowded trains and buses – and, often, interact with other people, at considerable risk to their health.

In the US, these fears led to collective action by workers at Whole Foods, a grocery subsidiary of Amazon. On March 31, 2020, in response to seeing their colleagues testing positive with COVID-19, workers decided to call in sick, and demand sick leave, free coronavirus testing and hazard pay. This was followed in April by work stoppages at some of America’s biggest companies, including Walmart, Target and FedEx.

Whilst early advice on protection and prevention focused on measures such as hand washing, the wearing of masks and gloves, and physical distancing, the ILO quickly realised that more needed to be done to address work-related issues.

“In the workplace, you have to think about more than just the individual worker: the whole environment needs to be protected’, explains Mr. Nunes. “One example that many of us will have come across is in shops and supermarkets, where it is now common to see PVC separators between cashiers and customers. Work surfaces are also being cleaned much more frequently, but this raises other concerns that need to be addressed, such as the potential for skin complaints or respiratory problems caused by the chemicals in cleaning products.”

Whilst areas such as healthcare and retail have been grappling with these issues for several months, other parts of the economy could soon be opening up. In several countries, plans are being made to allow gatherings of large numbers of people to take place, in venues such as concert halls and cinemas, and, heading into summer in the northern hemisphere, the range of permitted tourist activities looks set to expand.

However, for this to take place, and for economies to safely open, governments and employers, in collaboration with workers, will need to make sure that workers in these, and all other industries, are safe at their workplaces, and confident they will not be exposed to unnecessary risks, particularly those related to COVID-19.

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Biotechnologies: Commission seeks open debate on New Genomic Techniques

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research coronavirus

European Commission published, at the request of the Council, a study on New Genomic Techniques (NGTs). The study shows that NGTs, which are techniques to alter the genome of an organism, have the potential to contribute to a more sustainable food system as part of the objectives of the European Green Deal and the Farm to Fork Strategy.

At the same time, the study finds that the current GMO legislation, adopted in 2001, is not fit for purpose for these innovative technologies. The Commission will now start a wide and open consultation process to discuss the design of a new legal framework for these biotechnologies.

Commissioner for Health and Food Safety, Stella Kyriakides, said: “The study we publish today concludes that New Genomic Techniques can promote the sustainability of agricultural production, in line with the objectives of our Farm to Fork Strategy. With the safety of consumers and the environment as the guiding principle, now is the moment to have an open dialogue with citizens, Member States and the European Parliament to jointly decide the way forward for the use of these biotechnologies in the EU.”

NGTs developing rapidly in many parts of the world

NGTs, which can be defined as all techniques to alter the genome of an organism developed after 2001 (when the EU’s legislation on GMOs was adopted), have rapidly developed over the last two decades in many parts of the world, with some applications already on the market of some EU trade partners.

The main findings of the study are:

  • NGT products have the potential to contribute to sustainable food systems with plants more resistant to diseases, environmental conditions and climate change effects. Moreover, the products can benefit from higher nutritional qualities such as healthier fatty acid content, and reduced need of agricultural inputs such as pesticides;
  • By contributing to the EU’s objectives of innovation and sustainability of food systems, as well as a more competitive economy, NGTs can have benefits for many sectors of our societies;
  • At the same time, the study also analysed concerns associated with NGT products and their current and future applications. Concerns included the possible safety and environmental impact, for example, on biodiversity, the coexistence with organic and GM-free agriculture, as well as labelling;
  • NGTs are a very diverse set of techniques and can achieve different results, with some plant products produced by NGTs being as safe as conventionally bred plants for human and animal health and for the environment;
  • The study finds that there are strong indications that the current 2001 GMO legislation is not fit for purpose for some NGTs and their products, and that it needs adaptation to scientific and technological progress.

Next Steps

The study will be discussed with EU ministers at the Agriculture and Fisheries Council in May. The Commission will also discuss its findings with the European Parliament and all interested stakeholders.

In the coming months, an impact assessment, including a public consultation, will be carried out to explore policy options concerning the regulation of plants derived from certain NGTs.

Background

The study was prepared following a request from the Council of the European Union which, on 8 November 2019, asked the Commission to carry out “a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law.”

The study was conducted by the Commission and informed by expert opinions and contributions from Member States’ competent authorities and EU-level stakeholders via targeted consultations.

A wide range of participants was involved in the consultation, which preceded the preparation of the report. All contributions are published.

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