Background and Scope

egulatory approval (marketing authorization) is necessary for drug launch but is not sufficient to guarantee patient access to a licensed medicine. There is a time lag between a marketing authorization and patient access. The question of how long that lag is matters a great deal to patients. EFPIA sought to answer this question with empirical data.

• The rate of availability, measured by the number of medicines available to patients in European countries.
  • For most countries, this is the point at which the product gains access to the reimbursement list (see exceptions/explanations in callout box below).
  • In some countries, products are available with special reimbursement conditions (see exceptions/explanations in callout box below).
  • The rate of availability in a country does not necessarily indicate medicine uptake, as some medicines may be available in a market with no uptake (no sales or no volume).
• The average time between marketing authorization and patient access, measured by the number of days elapsed from the date of EU marketing authorization (or effective marketing authorization in non-EEA (European Economic Area countries) to the day of completion of post-marketing authorization administrative processes. Waiting times reflected in the Patients W.A.I.T. Indicator include any delay, whether attributable to companies or to competent authorities.

The analysis is based on information gathered from EFPIA member associations, who either refer to information available from official sources or gather this information directly from member companies.

Data Sources and Development Methodology

Results: Rate of Availability

• Patient access to new medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries and lowest in Southern and Eastern European countries.
• In some countries, up to 30 percent of products are available and reimbursed but with specific conditions.
• In 78 percent of the countries, the rate of availability is lower for Orphan drugs compared to all products approved in 2015-2017.
• In 78 percent of the countries, the rate of availability is higher for Oncology drugs compared to all products approved in 2015-2017.

Results: Market Access Delays

• The average delay between market authorization and patient access can vary by a factor greater than seven-fold across Europe, with patients in Northern/Western Europe accessing new products from 100-200 days after market authorization, but 600-1000 days from market authorization for patients mainly in Southern/Eastern Europe.
• Even within a country, there is a large variation in the speed of patient access to different products. Often the level of variation within a country is greater than the variation between countries; e.g., shortest versus longest delays in Estonia is 21 days versus 1443 days; zero (0) to 1321 days in Ireland; and 33 versus 1383 days in Austria.
• 80 percent of the countries have a longer average delay to EMA authorization for Orphan drugs compared to all products approved 2015-2017.
• The average delay between market authorization and patient access for Orphan drugs is between four months and three years.
• The average delay between market authorization and patient access for Oncology drugs is between two months and more than two and one-half years.

Results: Comparison to 2017 W.A.I.T. Indicator Study

Conclusions and Next Steps