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Home > Roadmap of Priorities: AIMS > Patient's WAIT Indicator

Delays and inequalities in patient access to new medicines

Patients' WAIT Indicator

The Patients' W.A.I.T. Indicator - Report 2009 identifies the delays patients experience when accessing new medicines throughout the European Union. In most Member states, a marketing authorisation is not synonymous with market access - price fixing procedures and/or access to reimbursement procedures can delay a medicine's market access.

The Patients' WAIT Indicator focuses on the following key issues:

  • new medicines should reach the market in a timely fashion delay (administrative delays should be reduced to a minimum, and should never exceed timelines prescribed by the "Transparency Directive")

  • at a reasonable price (administrative decision should make it possible for the company to put the medicine on to the market)

  • they should be reimbursed at normal conditions (inadequate reimbursement levels and/or conditions may constitute an hurdle for patient accessing medicines)

  • and that delays in market access not only deprive patients from new medicines they need, it also has an impact on the cost of disease to society.
Meanwhile,progress has been made in granting marketing authorisation procedures throughout Europe. The "4-year-gap" has been reduced over time to a 15-month gap, but still, recent studies show that delays are still too long, and that patients in some European countries have to wait for well over a year before they can benefit from new medicines commonly prescribed to patients in other countries.

The final aim of the Patients WAIT Indicator is to provide a basis for a joint debate between the pharmaceutical industry and national competent authorities, with a view to searching for sustainable solutions aimed at reducing to a minimum, the administrative delays that unduly delay patient access to these medicines.

The latest edition - the Patients' W.A.I.T. Indicator - Report 2009 - shows that, depending on the patients' country of residence, doctors would be able to prescribe between 47% and 90% of the new medicines with a valid EU marketing authorisation granted between 1 January 2006 and 31 December 2008. For those new medicines that doctors can prescribe under the national healthcare provisions, average time elapsing between the date of EU market authorisation and the "accessibility" date in 15 European countries will vary from 101 to 412 days.


Patient Access to Cancer Drugs in Europe - Karolinska Study

A study conducted by the Karolinska Institutet in conjunction with the Stockholm School of Economics - 'Comparator Report on Patient Access to Cancer Drugs in Europe' (January 2009), reveals significant inequalities in patient access to cancer drugs in Europe. These inequalities and gaps in survival of cancer patients are particularly noticeable when comparing Eastern Europe with Northern and Western Europe.

Patients in Austria, France and Switzerland have the broadest access to newer cancer treatments while Poland, the Czech Republic and the UK continue to lag behind.
The report urges policy-makers to take action - 1.2 million deaths were caused by cancer in Europe in 2006 - and proposes new policies to improve treatment access for patients in Europe:

  • adapt healthcare budgets generally and hospitals budgets specifically to incorporate the introduction of new cancer drugs
  • introduce separate funding for cancer drugs, with or without requirements of an additional gathering of data
  • expedite (regulatory and economic) review times for innovative cancer drugs
  • promote a European collaborative approach to collect available scientific information for Health Technology Assessment (HTA)
Documents & Links
  • Access to innovative treatments in multiple sclerosis in Europe
    Report (October 2009)

  • Access to innovative treatments in multiple sclerosis in Europe
    Key Facts & Figures (October 2009)

  • Patients' WAIT Indicator - Report 2009

  • Comparator Report on patient access to cancer drugs in Europe
    Report (October 2009)

  • Comparator Report on patient access to cancer drugs in Europe - Key Facts & Figures 2009

  • A pan-european comparison concerning patient access to cancer drugs - Complete Report 2005
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