The sustained and challenging economic environment in the EU has impacted – and is impacting - pharmaceutical companies as never before. But success is still possible for those that understand the new operating environment and can navigate through the changes.
With health expenditure under scrutiny throughout the EU, spending on drugs has been targeted as a key area for cost savings. Now, gaining EU marketing authorisation from the EMA for a new drug is no longer a guarantee of commercial success, and companies must respond to national market conditions where a product must prove not just clinical effectiveness but show real economic advantage and benefits.
A high value market
The main pharmaceutical markets of the EU still rank among the world’s best for innovative medicines. The pharmaceutical market value of the top 5 EU markets at ex factory prices exceeded €101,627 million in 2011. Despite health payer encouragement to use generic alternatives, generic drugs accounted for relatively little of the value, for example 30.6% in Germany but only 9.7% in Italy. The challenge facing each country in controlling its drugs bill is illustrated by per capita pharmaceutical expenditure: In France this was €608 while in Spain in was €299.
Drug pricing and reimbursement policies evolve
Countries vary in their response to tackling the funding of drugs and strategies to control the market through drug pricing and reimbursement policies continue to develop. The willingness to act has gone beyond clinician encouragement, voluntary codes and pricing deals. A raft of regulatory changes in Germany, France and the UK will see fundamental changes to drug pricing and reimbursement assessment. For the Pharma industry it’s tight, and it’s getting tighter.
Essential market access data and insights are now available in this new report
Using secondary source information, much of which is not available in English, this report, Market Access in the EU5 – a comparative overview, provides a detailed snapshot of the current environment and trends that are influencing market access in the five leading EU markets: France, Germany, Italy, Spain and the UK. A comprehensive overview provides valuable insights and tables of key indicators allowing easy “compare and contrast” assessment. This is followed by country specific sections examining at a national level the current status and future changes to pharmaceutical regulation, pricing, reimbursement in the context of health, demographic and economic trends.
The report answers practical questions:
Who are the key decision makers for pricing and reimbursement in the major EU markets? What are the forthcoming changes with regard to drug pricing systems? What criteria are assessed for reimbursement decisions and how do these vary country to country? Does inclusion in the national formulary mean a drug will automatically be available to patients throughout the country? Are the rules for pricing and reimbursement any different for generics, compared with those for innovative medicines? Are demographic or economic trends having a real effect on pharmaceutical spending?
Drill down into the issues that are shaping the markets and evaluate:
The introduction of formal medico-economic assessments in autumn 2013 in France The Amendment to the German AMNOG act and the impact it may have on new innovative medicines Why companies would be wise to engage with regional government in Italy The role managed entry agreements play in Spain The impact of the introduction of value based pricing in the UK in 2014
The leading EU pharmaceutical markets Background information: demographic and economic indicators Payer-led, economy driven healthcare Regulatory authorities/European Medicines Agency Evolution in pricing and reimbursement
Market access considerations Regulatory authority: Agence Nationale de Securitié du Médicament (ANSM) Pricing and reimbursement Market environment Demographic and economic indicators Trends in health and pharmaceutical spending Healthcare provision
Market access considerations Regulatory authority: Federal Institute for Drugs and Medicinal Products (BfArM) Pricing and reimbursement Market environment Demographic and economic indicators Trends in health and pharmaceutical spending Healthcare provision
Market access considerations Regulatory authority: Agenzi Italiana del Farmaco (AIFA) Pricing and reimbursement National regulation, regional implementation Market environment Demographic and economic indicators Trends in health and pharmaceutical spending Healthcare provision
Market access considerations Regulatory authority: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Pricing and reimbursement Market environment Demographic and economic indicators Trends in health and pharmaceutical spending Healthcare provision
Market access considerations Regulatory authority: Medicines and Healthcare Regulatory Agency (MHRA) Pricing and reimbursement Market environment Demographic and economic indicators Trends in health and pharmaceutical spending Healthcare provision
Table Of Contents
Market Access in the EU5 - a comparative overview 1.Executive summary 1.1.The leading EU pharmaceutical markets 1.2.Background information: demographic and economic indicators 1.3.Payer-led, economy driven healthcare 1.4.Regulatory authorities/European Medicines Agency 1.5.Evolution in pricing and reimbursement
2.France 2.1.Market access considerations 2.2.Regulatory authority: Agence Nationale de Securitie du Medicament (ANSM) 2.3.Pricing and reimbursement 2.4.Market environment 2.5.Demographic and economic indicators 2.6.Trends in health and pharmaceutical spending 2.7.Healthcare provision
3.Germany 3.1.Market access considerations 3.2.Regulatory authority: Federal Institute for Drugs and Medicinal Products (BfArM) 3.3.Pricing and reimbursement 3.4.Market environment 3.5.Demographic and economic indicators 3.6.Trends in health and pharmaceutical spending 3.7.Healthcare provision
4.Italy 4.1.Market access considerations 4.2.Regulatory authority: Agenzi Italiana del Farmaco (AIFA) 4.3.Pricing and reimbursement 4.4.National regulation, regional implementation 4.5.Market environment 4.6.Demographic and economic indicators 4.7.Trends in health and pharmaceutical spending 4.8.Healthcare provision
5.Spain 5.1.Market access considerations 5.2.Regulatory authority: Agencia EspaÃ±ola de Medicamentos y Productos Sanitarios (AEMPS) 5.3.Pricing and reimbursement 5.4.Market environment 5.5.Demographic and economic indicators 5.6.Trends in health and pharmaceutical spending 5.7.Healthcare provision
6.UK 6.1.Market access considerations 6.2.Regulatory authority: Medicines and Healthcare Regulatory Agency (MHRA) 6.3.Pricing and reimbursement 6.4.Market environment 6.5.Demographic and economic indicators 6.6.Trends in health and pharmaceutical spending 6.7.Healthcare provision