Workshop on the joint procurement of medical countermeasures – 29 April 2015

Access to High-Cost Medicines

Dirk Van den Steen

Healthcare Systems Unit

European Commission Directorate-General for Health and Consumers

European Commission Vision: To ensure accessible and affordable treatments for all EU citizens and to minimize unintended effects from current pricing systems in Member States, by improving cooperation and coordination at EU-level.

Access to Medicines: EU added value

Access to Medicines: EU added value

Commission Declaration: "[… the use of the joint procurement mechanism, developed by the Commission at the Council’s request to counteract cross-border health threats, was further explored. The range of medical countermeasures that can be procured through this mechanism was confirmed in December last year. The joint procurement mechanism may help to improve access to medicines at more balanced conditions from the pharmaceutical industry. …]"

http://ec.europa.eu/health/files/committee/73meeting/73plus/study_report.pdf

Problem Drivers?

http://ec.europa.eu/health/systems_performance_assessment/docs/erp_reimbursement_medicinal_products_en.pdf

Real-life Impacts?

TFEU: Article 168(7) of the Treaty, Member States are responsible for the definition of their health policies as well as for the organisation and delivery of health services. This includes measures regulating the prices of medicines and their inclusion in health insurance systems. But, Article 168(2) the Union shall encourage cooperation between the Member States.

EU level mandate

Commission Communication and Agenda for Action

Commission Communication and Agenda for Action

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I would like you to focus on

working together with the

Commissioner For Internal Market,

Industry, Entrepreneurship and

SMEs to jointly develop EU policies

as regards medicines and

pharmaceutical products while

taking fully into account that

medicines are

not goods like any other.

• Objective to secure a high level of public health and innovation.

• Access to medicines and treatments is affordable.

• Medicines are safe and effective.

• Objective to provide support for a competitive industry that ensures that Europe continues to benefit from new medicines.

• Enhance the competitiveness of Europe’s pharmaceutical sector.

Initiatives on pricing

• Despite the limited competence, there is a growing impetus to discuss at the EU level.

• Links with the accessibility of medicinal care have been raised in a number of recent Council Conclusions.

• The Commission is fostering cooperation between Member States in order to find synergies.

• Overall goal to achieve better and enhanced cross-country coordination at EU level in the area of pharmaceutical pricing.

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EU level discussions

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Initiatives on pricing

• The Health Programme 2014-2020 to support the policy debate, build up a sound evidence base and explore possible policy avenues.

• A project grant to improve information sharing on the prices of medicinal products (expected to start in 2015 for a duration of 3 years).

• A study exploring alternative pricing approaches as well as related cooperation mechanisms in view of possible impacts, including on patient access (delivery by the end of 2015).

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The challenge at hand: Prices affordable to all, combined

with free movement of goods?

13 http://ec.europa.eu/economy_finance/publications/economic_paper/2012/pdf/ecp_461_en.pdf

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Source of data Eurostat

Short Description Short Description is not available

UNIT Current prices, euro per capita

NA_ITEM Gross domestic product at market prices

GEO/TIME 2013

European Union (28 countries) 26.600 100

Luxembourg 83.100 312

Sweden 45.500 171

Denmark 45.100 170

Netherlands 38.300 144

Austria 38.100 143

Ireland 38.000 143

Finland 37.100 139

Belgium 35.600 134

Germany (until 1990 former territory of the FRG) 34.200 129

France 32.100 121

United Kingdom 31.500 118

Italy 26.500 100

Spain 22.500 85

Cyprus 21.000 79

Malta 17.900 67

Slovenia 17.500 66

Greece 16.500 62

Portugal 16.200 61

Czech Republic 15.000 56

Estonia 14.200 53

Slovakia 13.600 51

Lithuania 11.800 44

Latvia 11.600 44

Croatia 10.200 38

Hungary 10.200 38

Romania 7.200 27

Bulgaria 5.600 21

Poland NA NA

http://www.scb.se/Statistik/PR/PR0401/_documents/Pharmaceutical%20Products.pdf

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Main Consideration for the JPA vis-à-vis access to medicines

How to address the issue of "price" under the JPA?

Can there be several JPAs for a given product, clustering Member States by purchasing capacity?

If so, what is an acceptable trade-off between getting

the lowest possible price by pooling market size

vs

he highest possible accessibility by differentiating price?

•

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Thank you!

European Commission

Public Health information:

http://ec.europa.eu/health/systems_performance_assessment/policy/index_en.htm

http://ec.europa.eu/europe2020/making-it-happen/index_en.htm