Medicines shortages: root causes and potential solutions

2019 12 06 Written by Vaccines Europe

Medicines shortages are a significant cause of concern for patients, clinicians and our public health. They impact on patients’ health outcomes by causing delays in treatment or forcing changes in treatment regimes as well as inducing a great deal of stress and worry to patients and their families.

The European associations representing manufacturers of vaccines and medicines, parallel distributors, pharmaceutical full-line wholesalers and industrial pharmacists are committed to working with the EU and member states to progress short term and longer term solutions addressing the root causes of medicines shortages that occur across Europe.

The root causes of medicines shortages include manufacturing, quality, economic, and supply chain issues. Our associations are committed to stepping up efforts to prevent and to mitigate medicines shortages. As a group, we believe that the root causes of shortages can be addressed by a set of short term and longer term solutions including harmonising data and monitoring medicines shortages at EU level, creating regulatory incentives for essential low-priced medicines, allowing regulatory flexibility and improved regulatory efficiency to mitigate shortages, and ensuring market stability and sustainability.

We call for a dialogue with EU and national competent authorities in order to implement solutions effectively addressing the root causes of shortages in the short, medium and long term perspectives rather than placing short term disproportionate requirements on manufacturers and supply chain stakeholders that could have opposite effects to the ones intended.

You can access our position paper here.

 

Notes to Editors

  1. The joint paper on addressing the root causes of medicines shortages in full can be accessed here.
  2. The joint paper has been developed and agreed by the following organisations:
  • The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. AESGP was founded in 1964 to contribute to the improvement of responsible self-medication at the European level and to ensure that the value of responsible self-care is recognised in pharmaceutical, food and health matters.
  • The European Association of Euro-Pharmaceutical Companies (EAEPC) represents Europe’s licensed parallel distribution industry, an integral part of the European pharmaceutical market that adds value to society by introducing price competition and a supplementary layer of safety for medicines. We represent 125 companies in 23 EU/EEA Member States. These members account for approximately 85% of the total parallel import market volume in the EU/EEA.
  • The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines.
  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 36 national associations and 39 leading pharmaceutical companies, EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients.
  • The European Healthcare Distribution Association (GIRP) is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 34 European countries, as well as major international and pan-European healthcare distribution companies. GIRP members employ over 140,000 people and distribute around 15 billion packs of medicines as well as a wide range of healthcare products per year. As the vital link in healthcare, they are committed to developing and providing innovative and efficient healthcare products and services to improve health and wellbeing of patients across Europe.
  • Medicines for Europe (formerly EGA) represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
  • Vaccines Europe (VE), is a specialised vaccines group within the European Federation of Pharmaceutical Industries and Associations. Formed in 1991, Vaccines Europe represents major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe which account for a large share of human vaccines used worldwide. Companies represented within Vaccines Europe are involved in research and development (R&D), clinical trials, production and marketing of vaccines and are dedicated to improving public health through immunisation.

2020 Early Career Research Prize in Vaccinology R&D

2019 11 29 Written by Vaccines Europe

The Early Career Research Prize in Vaccinology R&D is awarded by the International Union of Immunological Societies (IUIS) with the contribution of Vaccines Europe. The 2020 Prize edition aims at rewarding significant achievements in Vaccines R&D in Europe.

The Prize rewards the discovery of new vaccine antigens, new vaccines design, understanding the basics of immune responses, new technologies that will improve the future of vaccines and vaccination and that are supported by proof-of-concept data (preclinical and clinical).

For information regarding application criteria, follow this link.

 

Have your say and contribute to the strategic research agenda for a Public-Private Partnership for Health Innovation under Horizon Europe!

2019 10 23 Written by Vaccines Europe

Five industry associations representing pharmaceutical, biotech and medical technologies industries operating in Europe (COCIR, EFPIA, MedTech Europe, EuropaBio and Vaccines Europe) have come together to work on a Strategic Agenda for Innovation in Healthcare. This Agenda falls in the framework of the proposed European Health Innovation Public-Private Partnership (PPP) under Horizon Europe. Its objective is to guide future public-private research & innovation that would contribute – alongside other European research funding instruments – to addressing some key European healthcare challenges in an integrated manner.

Today, the private sector is interested to invest in a new health Public-Private Partnership and would like invite citizens, patients, health and research communities, national authorities, academia and scientific societies to provide their input to make sure that this Strategic Agenda:

  • aligns with the needs of European health and research communities
  • is both ambitious and feasible
  • is clearly complementary with other European and national initiatives

Horizon Europe offers a thrilling opportunity to move to the next stage of innovation in healthcare, and contribute to improving European citizens’ health, strengthen health systems and create a thriving health R&D environment. It also offers further possibilities through the creation of institutionalised Public-Private Partnerships. The goal is to create a unique platform that does not exist anywhere else, a European multi-sector Partnership for health innovation. We strongly believe that by pioneering and de-risking multisector precompetitive collaboration we can together put Europe at the forefront of health innovation.

You have an opportunity to learn more about the proposed partnership and ask questions during a dedicated webinar on 4 November 14.00 CET – register here!

You can contribute to this consultation by filling in the online questionnaire until 24 November midnight.

If you are unable to use the online questionnaire, please send your contribution to contact@EUHealthPPP.org.

If you represent a company member of COCIR, EFPIA, EuropaBio, MedTech Europe, or Vaccines Europe please send your contribution to your respective trade association for traceability and faster processing, and to ensure proper representation:

COCIR: eberstein@cocir.org

EFPIA: magda.chlebus@efpia.eu

EuropaBio : B.Grimm@europabio.org

MedTech Europe: p.boisseau@medtecheurope.org

Vaccines Europe: anna.czwarno@vaccineseurope.eu

 

 

Vaccine Innovation: Europe’s Crucial Role in Advancing Global Public Health

2019 09 12 Written by Vaccines Europe

Vaccination is a success story. Over the last century, vaccines have eliminated or nearly eliminated many diseases that were once widespread and often fatal, such as smallpox and polio. In fact, vaccination is second only to clean water in reducing the global burden of infectious diseases. Today, close to 30 are vaccine-preventable – helping save 2-3 million lives globally every year.

Simply put, the impact of vaccines on global health to date has been nothing short of profound.

But arguably, what is even more moving and exciting than what vaccines have achieved so far is what they have the potential to achieve in the future. If we are to deliver on this potential, we must all work together to prioritize vaccine research and development (R&D).

Innovation drives the future

The innovation currently underway across the vaccine industry has the potential to address diseases that still challenge the medical community and threaten lives, despite the progress we’ve made. In some cases, this means protection against diseases for which there have been no vaccine breakthroughs – such as respiratory syncytial virus (RSV) and HIV. In others, it means developing even more effective vaccines than those that exist today – for diseases like flu and tuberculosis.

We are also exploring innovative vaccines throughout a person’s lifespan. Maternal immunization is a growing area of focus, for example. Maternal vaccines are administered to a mother during pregnancy so that immunity is passed to her child before they are even born – helping to protect them as soon as they enter the world, when they are most vulnerable. Today, there are maternal vaccines in development for prevalent and potentially deadly diseases impacting infants, including RSV, group B streptococcal bacteria, and herpes simplex. For me, this is personal – my own son, Javier, contracted RSV as an infant – and the potential to bring forward a vaccine that would protect others inspires me every day.

Maintaining Europe’s R&D leadership

Europe plays a critical role in vaccine development. More than 80 percent of vaccine doses produced by Vaccines Europe member companies globally are produced IN Europe.

We know that developing the next of generation vaccines will be more complex, more risky, and more costly than ever before. So what is the incentive for companies to continue to invest in R&D when health budgets in Europe are increasingly constrained, recommendations for new vaccines are often elusive, and we are facing a growing sentiment of vaccine hesitancy from the public – all of which can make bringing new vaccines to market feel like a losing battle?

If we want to see innovation continue, we need to commit as a global health community to some important actions:

  1. We need to address the lack of a stable policy environment to support vaccine innovation. Vaccines take longer than medicines to develop – and current policy does not incentivize vaccine R&D efforts. There needs to be increased recognition of the value that vaccines bring.
  2. Vaccine developers need opportunities to continuously interact with all stakeholders from the earliest stages of development – especially regulatory authorities and recommending bodies. This will help ensure that resources are not spent developing vaccines that are unlikely to be approved and recommended.
  3. Vaccines research needs to be better connected and coordinated, particularly in Europe. At the same time, we must strengthen our research focus on the needs of low-income countries and pandemic preparedness. Anticipating and preparing for future health threats is one of the great challenges of our time, and vaccines should be part of the solution.
  4. There needs to be a shift in the mindset of healthcare investment. Healthcare systems are still largely built on treating illness, not preventing disease. Less than 3 percent of healthcare budget expenditure, on average, is currently spent on prevention – and even less on vaccines. When it comes to investing in healthcare we should ask ourselves whether the balance is right.

These are not simple challenges. Prioritizing vaccine R&D will need the support and consensus of all stakeholder groups. Vaccine innovation is one of the most powerful tools we have for progress in global health, and we must make sure it continues to have a home in Europe.

Nanette Cocero is the Global President of Pfizer Vaccines. She represented Vaccines Europe on the panel “The Magic of Science: Boosting vaccine Research, Development, and Innovation” at the Global Vaccination Summit 2019.

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