COVID-19

To ensure manufacturing and supplying, day and night our members are continuously assessing portfolios, forecast, manufacture and supply to best meet the increasing demands posed by COVID19.

We are working closely with government and policy makers both at EU and national level so that we do all we can to maintain the development, production, supply and distribution of high-quality medicines during the pandemic

   

Key documents


SUPPLY


TREATMENT


TRANSPORT


REGULATORY


WORK FORCE

Useful links

Access

Our industries provide sustainable access to high quality medicines for all European patients, for generic, biosimilar and value added medicines. Every single day, our industries increase access to the best standard of care in all therapeutic areas.

Between 2005 and 2015, for the same budget, generic competition allowed twice as many patients access to medicines for key therapeutic areas such as diabetes, depression, epilepsy, cardiovascular disease, hypertension, asthma/COPD or gastro-intestinal disease.

Biosimilar medicines have also increased access to treatment with complex biological medicines. For instance, the introduction of biosimilar filgrastim, used to treat the consequences of chemotherapy, increased patient access by 44% across Europe. Not only could more patients get access to this treatment, physicians were also able to use the medicine earlier in the treatment cycle, to the benefit of the patient.

Why should you care about medicines policy, and what needs to be done? 

Because of ageing populations, budgetary constraints and rising healthcare costs – not helped by inefficiency and waste in the system – European healthcare faces unprecedented and growing pressures; pressures that are already threatening the viability of the European healthcare system. Something must be done to safeguard European citizens’ access to healthcare.

We launched the Access to Medicines project aiming to make the case for ensuring the sustainability of European healthcare systems, and a common-sense approach to make use of the opportunity that generic, biosimilar and value added medicines do and can bring.

Industrial Policy

The European medicines industry has extensive manufacturing capabilities in producing high quality generic, biosimilar and value added medicines throughout Europe. With over 400 manufacturing plants and 126 R&D centres in Europe, companies represented within Medicines for Europe provide over 190 000 skilled, high value direct jobs in Europe, and more than half a million indirect jobs. Medicines for Europe is committed to supporting industrial policy initiatives aimed at strengthening the European industrial base, increasing investments in R&D for generic, biosimilar and value added medicines, boosting EU competitiveness, and taking up the opportunities which are opening up in Europe and worldwide.

Europe must prioritise public health and access to medicines recognising the value of of a resilient and strong European generic, biosimilar and value added medicines industry and the need to increase investments in this field. We believe that manufacturing leadership and supply chain resilience rely on smart policymaking based on three key factors:

  1. The competitiveness of our manufacturing and the resilience of our supply chains are critical for healthcare.
  2.  Building on the European manufacturing footprint and investing in technological leadership will deliver a cost-effective solution aligned with public health needs. The EU should set an ambitious goal to restore Europe to its former position as the leading global manufacturing region for finished product (medicine) and active pharmaceutical ingredients (API) for both the EU and the global market.
  3. Policy reforms combined with effective implementation at the national level are necessary to drive investment to secure existing sites and increase pharmaceutical development, European manufacturing leadership and resilience.

The SPC manufacturing waiver is essential for the EU. Its introduction would create 25.000 direct jobs, €3.1 billion saving in EU pharmaceutical spending and net sales of the EU based pharmaceutical industry of €9.5 billion. The fast implementation of the SPC manufacturing waiver is key to avoid further technology transfer of pharmaceutical production outside Europe and boost R&D and manufacturing investment in Europe, without shifting the balance between originator and competitive pharmaceutical sectors.

 

As announced in the European Commission Communication on  a Pharmaceutical Strategy for the EU, a structured dialogue has been set up with the players in the pharmaceuticals manufacturing value chain, public authorities, patient and health non-governmental organisations and the research community. In its first phase, the structured dialogue will aim to gain a better understanding of the functioning of global supply chains and identify the precise causes and drivers of different potential vulnerabilities, including potential dependencies threatening the supply of critical medicines, active pharmaceutical ingredients and raw materials based on data collection and analysis.

In a second phase, the structured dialogue will serve to put forward a set of Key points and Extracts from the first meeting of the European structured dialogue on  February 26th, 2021 which included measures to address the identified vulnerabilities and formulate policy options to be considered by the Commission and other authorities in the EU to ensure the security of supply and the availability of critical medicines, active pharmaceutical ingredients and raw materials. While it is important to assess whether manufacturing capacity for certain critical medicines may be required in the EU from the perspective of public health and crisis preparedness, any potential measures would have to be in full compliance with EU competition and World Trade Organization (WTO) rules.

Key points and Extracts from the first meeting of the European structured dialogue on February 26th, 2021:

Participants agreed that the road towards robustness must not focus only on the current situation but also on looking ahead in order to prepare for the future. The ability to maintain and optimise open and well-functioning supply chains will require long-term policy measures to accelerate innovative and green production capacities. Participants also highlighted that the challenges to the manufacturing capability and capacity from the perspective of supply security depend on the form of products (solid, sterile/aseptic or complex molecules).

Speakers recommended considering a number of key topics within the work streams proposed. Namely:

  • regulatory flexibility
  • public private collaboration and support for investment
  • ensuring avoidance of protectionism.

Speakers also called for sustainable market conditions to improve resilience, investment in green production and reduction in environmental footprint.”  European Commission official website.

Everyone agreed on the need for the Initiatives and on the need to “…better understand the vulnerabilities and dependencies that create strategic risks for critical supply in the EU on the ground” to bring positive change » (European Commission Vice-President Margaritis Schinas).

Important market reforms have been pointed out, such as “Making security of supply a criterion as important as price in public procurement.”  (Ms. Nathalie Colin-Oesterlé, Member of the European Parliament).

The New European Pharmaceutical Strategy “…represents a great opportunity to put the patient at the centre of our policies and to attract and consolidate a competitive and diversified pharmaceutical industry in Europe with: a less bureaucratic and more efficient regulatory framework, without sacrificing security; market policies that facilitate the implementation of new scientific, technological and digital developments.” And with: “a new incentive system for: multiplying production capacities in Europe; creating a competitive ecosystem of manufacture supplying companies; maintaining the attractiveness of marketing essential medicines; covering unmet therapeutic needs.” (Ms Dolors Montserrat, Member of the European Parliament)

 

European Commission Structured Dialogue Initiative website Structured Dialogue initiative – Launch event | Public Health (europa.eu)

Keynotes from the European Commission first meeting of the European structured dialogue:

Opening speech by Vice-President Margaritis Schinas

Keynote speech by Commissioner Stella Kyriakides

Intervention by Portuguese Minister for Health, Marta Temido

Intervention by MEP Nathalie Colin-Oesterlé

Intervention by MEP Dolors Monserrat

 

Medicines for Europe statement on Industrial Policy addressed to the EUCO leaders

Regulatory and legal framework

In Europe the pharmaceutical legislation and existing guidelines regulate the entire lifecycle of medicines, from their development over their approval and entry on the market to their availability for the patient. Both Generic Medicines and Biosimilar medicines are important parts of the EU pharmaceutical legislation. Medicines for Europe and its member companies and associations support and promote a European regulatory framework that ensures patient access to high quality, safe and effective medicines and that focusses on the highest-priority issues that make the real difference for patients.

During the development of generic, biosimilar or value added medicines, clinical trials have to be performed to establish an equivalence with the originator product. Medicines for Europe and its members support a strong EU Good Clinical Practices (GCP) system as a cornerstone for ensuring the quality of the clinical data supporting marketing authorisations of all medicines. In view of the globalisation of the industry and to avoid of unethical repetition of studies for the purpose of marketing authorisations in several regions, Medicines for Europe calls for a high-standard global regulatory convergence in the field of clinical trials, enabling the single global development of generic, value added or biosimilar medicines.

Before a medicinal product is allowed access to the market it needs to be registered and obtain a marketing authorisation which needs to be updated by variations throughout the lifecycle of the product. In the light of the importance of an efficient regulatory system in providing greater and timely access to high quality medicines for patients across Europe, Medicines for Europe has published the Regulatory Efficiency Report which proposed several solutions to remove unnecessary duplications, reduce administrative burdens and promote the effective use of IT systems to support regulatory processes. Special emphasis is placed on the optimisation of the variation system, which is particularly burdensome for authorities and industry.

Once the product is on the market, the quality, safety and efficacy needs to be assured. In this regard, Medicines for Europe encourages the production of pharmaceutical ingredients and medicinal products to the highest standards of excellence. All the individual companies represented by Medicines for Europe abide by the rules of Good Manufacturing Practice (GMP) in approved and regularly inspected production plants. Moreover they are committed to maintaining a stringent overview of their suppliers and outsourced activities and to set up resilient supply chains to guarantee a sustained access to medicines for patients.

All the members of Medicines for Europe have a pharmacovigilance system in place to monitor the safety of their products on the market.

Falsified medicines

Patient health and safety is of the utmost importance to Medicines for Europe which is engaged in numerous initiatives that are fighting against counterfeit medicines.

  • EMVO (European Medicines Verification Organisation): The European Medicines Verification System (EMVS) is an interoperable pan-European Information Technology system that verifies the authenticity of medicines at the point of dispense to patients (in a local pharmacy or a hospital) in compliance with the EU Falsified Medicines Directive (FMD) and its supplementing Delegated Regulation (DR). The system connects all prescription medicine manufacturers to an EU hub and all pharmacies and hospitals to connected 31 national hubs across the EU and the EEA. EMVO, which is financed by manufacturers, is the biggest medicines verification IT system established in the world to date. Medicines for Europe presides over the board of EMVO for the period 2019-2021.
  • Fight the FakesFight the Fakes is a campaign to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working stop to this threat to public health.
  • ASOP: The Alliance for Safe Online Pharmacies (ASOP) protects patient safety by providing to safe and legitimate online pharmacies in accordance with applicable laws.
  • Fakeshare: Fakeshare is a European project dealing with cooperation and intelligence against the online selling of falsified or illegal medicines through non authorized e-pharmacies or other resellers.

Environment

The European pharmaceutical industry, represented by the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries (EFPIA), and Medicines for Europe, recognises and understands the concerns raised by stakeholders as regards the presence of pharmaceuticals in the environment (PiE). For this reason, we have come together to develop the Eco-Pharmaco-Stewardship (EPS) concept, a proposal that strives to protect patients’ access to medicines while appropriately considering environmental aspects.

Environmental concerns should not overshadow public health benefits

Medicines play a critical role in ensuring a high level of public health, and we believe that political debates on PiE should not overlook the value that medicines bring to European citizens. As pharmaceuticals can enter the environment at all stages of the product’s life cycle, reducing pharmaceuticals in the environment will be the result of cooperation between the public and private sector and the consumers they serve. Therefore, all actions should strike the optimal balance between economic costs and the benefit of medicines to public health. This principle is very much part of the EPS.

The pharmaceutical industry proposes actions in areas where it has leverage

The pharmaceutical industry believes that environmental protection contributes to ensuring the health and safety of future generations. Most aspects of the EPS are readily implementable under current pharmaceutical legislation, thus avoiding the need for additional regulation. The proposal looks at three areas where the industry can most effectively reduce the potential environmental risks that might result from its activities and throughout the medicinal products life cycle:

  • Pillar 1 – Encouraging further research to assess the impact of PiE: The pharmaceutical industry is actively engaged in scientific research projects (independently and in partnership) aimed at filling the priority knowledge gaps for “legacy” APIs, medicinal products approved before 2006, in order to support informed science-based policy-making on PiE. The industry has initiated the iPiE project (Intelligence-led Assessment of Pharmaceuticals in the Environment) in a public-private partnership with the European Commission under the umbrella of the Innovative Medicines Initiative (IMI). This multi-stakeholder project aims at developing models for prioritising legacy products for more in-depth environmental assessment. In addition to prioritising legacy APIs, the models may also be applicable to new molecules in the early R&D stages. The project will use all available scientific knowledge to develop tools and assays, which will prioritize and identify the pivotal areas where more data would strengthen the understanding of a potential risk for medicinal products in use today, enabling the most efficient and effective use of resources. The project ended in 2019 and published the final report available here. The newly established project: IMI Premier (Prioritisation and risk evaluation of medicines in the environment) (Kick off September 2020): aims to deliver a novel assessment system for characterising the environmental risks of APIs, and which can be used to:screen and prioritise legacy APIs for a tailored environmental assessment
    • Identify potential hazards associated with APIs in development and explore the options to steer the design process in a greener direction;make relevant environmental data on APIs more visible and accessible to all stakeholders.
  • Pillar 2 – Manage pharmaceutical site effluent effectively: For the most part, the processes used to manufacture medicinal products are largely similar wherever in the world they may be used. It therefore follows that potential losses into the environment from manufacturing facilities should also be equally controllable Whilst the overall contribution of pharmaceutical manufacturing to PiE is relatively low compared with that from other sources, the pharmaceutical industry has developed and is continuously implementing initiatives which minimise API discharges from manufacturing operations through the exchange of good practices. In an effort across the industry, experts from several major manufacturers have shared experiences and developed a “maturity ladder” and associated guidance, in order to enable an enhanced understanding of the existing methods and the potential need for specific methodologies relative to the potential environmental risk posed by APIs and/or manufactured medicinal products. Manufacturing companies are encouraged to exchange practices in further developing their level of effluent control systems.
  • Pillar 3 – Monitor environmental impact through extended Environmental Risk Assessment (eERA): An important cornerstone of EPS is a refined Environmental Risk Assessment (ERA) process, extending beyond marketing authorisation. The ERA of a medicinal product is currently performed by companies either as part of a new marketing authorisation or when an increase in the environmental exposure is expected, e.g. with the approval of a new indication or the inclusion of a new patient population. ERA must be performed to evaluate potential risks of medicines on the environment and ensure adequate precautions are taken where specific risks are identified. The extended ERA (eERA) includes provisions to: (i) adjust exposure predictions as usage figures become available to better reflect reality, including all products with the same API, and (ii) reconsider the effects profile, as relevant and reliable laboratory findings and/or observations in the field linked to an adverse outcome become available.

In addition to these specific areas for action, the pharmaceutical industry stands ready to support European and MSs communication activities and awareness raising campaigns aimed at patients and public on the appropriate use, storage and disposal of medicines. A social media campaign #medsdisposal on the appropriate disposal of medicines was launched in June 2015. This is a joint initiative between European healthcare, industry and student organisations. Further information is available at http://medsdisposal.eu/.

Medsdisposal is an online communication campaign aimed at raising public awareness on the existing collection and disposal schemes already in place in Member States, emphasizing the fact that it is everyone’s responsibility and it is easier than one may think.

  • Open letter from EFPIA, AESGP and EGA addressing the public debate regarding pharmaceuticals in the environment, antimicrobial resistance and the manufacturing aspect: view here

Joint Press Statement of the Inter Associations Initiative (IAI) Pharmaceuticals in the Environment Task Force (AESGP, EFPIA, Medicines for Europe) – European Union Strategic Approach to Pharmaceuticals in the Environment: view here

  1. Open letter from EFPIA, AESGP and EGA addressing the public debate regarding pharmaceuticals in the environment, antimicrobial resistance and the manufacturing aspect: view here
  2. Eco-Pharmaco-Stewardship (EPS) – Pillar 1 – Research & Development: Intelligence led assessment of pharmaceuticals in the environment (iPiE): view here
  3. Eco-Pharmaco-Stewardship (EPS) – Pillar 2 – Manufacturing: Effluent management (Abstract): view here
  4. Eco-Pharmaco-Stewardship (EPS) – Pillar 3 – Extended environmental risk assessment (eERA): view here

Antimicrobial resistance

Antibiotic medicines are a cornerstone of modern medical practice. Not only do they treat a wide range of infectious diseases, but they also guarantee patient safety during medical procedures, such as transplants, in hospitals. Whilst antimicrobial resistance (AMR) is a natural phenomenon, it has increased dramatically over the last 20 years, making it a serious threat to public health, thus jeopardizing healthcare providers’ ability to manage life-threatening infections.

There are significant contributions that individual organizations can make, and industry has a role to play as part of a global collective and coordinated effort for to manage the threat of AMR. The European generic medicines industry is engaged in the antimicrobial resistance policy debate and will actively support efforts to ensure that European patients receive access to effective antimicrobial treatments.(view video here)

As member of the AMR Industry Alliance, Medicines for Europe fully supports the implementation by industry of the AMR IA Common Manufacturing Framework and the supportive PNECs. The industry driven initiative to work toward achieving these antibiotic discharge concentration targets will be both protective of ecological resources and also lower the potential for the evolution and selection of AMR in the environment. Watch video here 

Being the main provider of antibiotic medicines, the generic medicines industry wishes to put forward a number of policy recommendations to counter the spread of antimicrobial resistance whilst ensuring patients’ access to life-saving antibiotics.

Tackling the threat of AMR requires a comprehensive and collaborative response involving key healthcare stakeholders: government, industry, healthcare providers and patients.

  1. Increasing knowledge on antimicrobial resistance and antibiotic use in human medicine
    Whilst there is increasing data available about the spread of antimicrobial resistance in Europe, we believe that specific figures on the use of antibiotics in human medicine would allow us to better identify and address the current trends and challenges of antibiotic use over time based on consistent and standardized criteria.
  2. Promoting the prudent use of antibiotics
    As the spread of AMR is driven by the inappropriate and/or overuse of antibiotic medicine, it is crucial that patients and all healthcare professionals (including dentists and nurses) use antibiotics appropriately. For instance, patients should be full informed on the importance of finishing a treatment course, even when their condition seems to improve.
  3. Reinforcing patient education on use of antimicrobial medicines
    Lack of adherence to treatment and stopping the therapy too early is one of the causes of antimicrobial resistance.
    This educational element should be a regular part of medical consultation with doctors and regularly confirmed by pharmacists when medicines are dispensed in pharmacies.
  4. Ensuring the security of supply chain and availability of life-saving antibiotics in the EU
    The sustainability of antibiotic medicine supply is also a critical issue for the EU. Despite the increase of AMR, antibiotic medicines remain indispensable to perform a number of medical procedures or treat major infectious diseases. It is therefore crucial to ensure a continuous supply of high-quality antibiotics in the EU and to avoid shortages that can put patients’ lives at risk.
  5. Establishing responsible R&D incentives
    The traditional business model does not encourage the development of new generation antibiotics due to the low prices, and the fact that any new antibiotic coming onto the market that would come on the market would only be used in a restrictive manner (i.e. as a last resort when other antibiotics prove ineffective). In order to incentivize antibacterial R&D and ensure that initial R&D investments are recouped, a new model of research and incentives is needed, which needs to be un-linked from the volume of sales in order to contain any further spread of AMR.
  6. Addressing the potential environmental causes
    It is difficult to assess the risk of AMR associated with the environment. The link between the effluent from pharmaceutical manufacturing facilities and the spread of antimicrobial resistance should be investigated and substantiated by the relevant environmental authorities.
    Although there should not be any leftovers and excess prescribing when it comes to antibiotic treatments, the fact that unused antibiotics are not being properly disposed of needs to be tackled. Medicines for Europe, together with industry colleagues, is working on the take back of unused medicines (including antibiotics) to pharmacies to ensure they are properly disposed of: see medsdisposal campaign.

Medicine shortages

Generic medicines have proven to be pivotal in increasing patient access and preventing medicine shortages through increased choice and availability of treatments. However, generic medicines policies have recently focused exclusively on reducing prices thereby increasing the risk of medicine shortages.

The sustainability of healthcare budgets in Europe has been intensely pressured by multiple factors, such as a growing and ageing population, an increased disease burden, the introduction and increased cost of new innovative medicines[1],[2],[3]. To overcome these challenges, several national authorities have adopted austerity measures and applied short-term cost-containment measures to pharmaceuticals, including to generic medicines despite their low cost (around 4% of total healthcare expenditure in Europe) and their relevance for care (62% of medicines dispensed today in Europe are generic medicines).  Short-term cost-cutting measures, such as ad-hoc price cuts, external reference pricing, payback, tendering, etc. have driven the prices of some off-patent medicines to unsustainably low levels. This causes manufacturers of generic medicines to withdraw from the market, resulting in the increased risk of medicine shortages[4],[5],[6]. The evidence now shows that many national markets across Europe are relying on too few suppliers for essential life-saving medicines in both the hospital and ambulatory sectors. Tackling medicines shortages in a multi-source context, requires an approach that addresses both the root causes of medicines shortages and mitigates medicine shortages once they occur. Addressing the economic causes of shortages to ensure market predictability and competition, improving regulatory efficiency, improving transparency in supply chain and a proper and controlled communication are important measures to tackle medicine shortages. Please find more information on Medicines for Europe key recommendations to tackle medicines shortages here and the Economist Intelligence Unit report on medicine shortages here.

Industry Supply Chain Resilience (Damien Holly – Sandoz – December 2020)
Executive letter
Position paper
Addressing the root causes of medicines shortages
The Economist Intelligence Unit report “Addressing medicine shortages in Europe”
Infographic: Medicines Shortages: Causes and Recommendations
Infographic: Medicines Shortages: Causes and Recommendations Explained

Medicine Shortages Webinar: Damian Holly, Supply Chain Resilience Overview presentation

[1] The Parliament Magazine. 2015. Available at:- https://www.theparliamentmagazine.eu/articles/opinion/many-patients-europe-have-limited-or-no-access-treatment

[2] Eurostat Population Statistics

[3] OECD, Fiscal Sustainability of Health Systems: Bridging Health and Finance Perspectives. 2015.

[4] SFK (Foundation for Pharmaceutical Statistics), Pharmaceutisch Weekblad. 2014.

[5] APM Health 2015. Available at: http://www.apmhealtheurope.com/home.php.

[6] QuintilesIMS Health. An International Comparison of Best Practice Approaches to Drug Shortages. 2015.