18
CANCER MEDICINES SHORTAGES IN EASTERN EUROPE Dr Vlad Mixich Hearing of European Parliament Special Committee on Beating Cancer 28 January 2021 A PERFECT STORM
CANCER MEDICINES SHORTAGES IN EASTERN EUROPE
Dr Vlad MixichHearing of European Parliament Special Committee on Beating Cancer28 January 2021
A PERFECT STORM
Member States should also ensure that the overarching values ofuniversality, access to good quality care, equity, and solidarity arerespected with regard to patients and citizens from other Member States,and that all patients are treated equitably on the basis of their healthcareneeds rather than on the basis of their Member State of affiliation.
Guiding Words
- EU DIRECTIVE 2011/24/EU
Year 2016 Year 2017 Year 2018 Year 2019 Year 2020
6,000
4,000
2,000
0
SHORTAGESNOTIFICATIONSYearly Comparison in Romania
Medicines shortages should be notified to the authorities bypatients or healthcare professionals on public websites or bypharmacies to the regulatory authorities. This can be used assignals to assess shortages risk.
Not advertising the ways to notify shortages will lead tounderreporting.
REGISTERED SHORTAGES Essential Medicines Most frequent in 2019
Bleomycin Temozolomide Cisplatin MycophenolatDacarbazine CiclosporinDasatinib NilotinibLeuprorelin 5-FluorouracilLinezolid PazopanibVinblastine ProcarbazinVinorelbin5-Fluorouraciletc.
Available Accessible
Internal PricingManufacturing
External Pricing
Supplychains
ParallelTrade
Guidelines Procurement
HTA
STATUS OF CANCER PHARMACEUTICALSPRODUCTS IN ROMANIA
Accessible47.3%
Not launched43%
Not accessible due to commercial reasons7.4% 2.2% not accessible
due to manufacturing issues
Based on the status of 150 cancer medicines analyzed in December 2019
Maini L, Pammolli F, | 2017
DELAY BY DESIGN
Average delay from EMAapproval to national access
Germany average 119 days
EU average 445 days
Romania average 775 days
SUCH A MAZEExternal Reference Pricing Significant Price Differences
One size does NOT fit all
MULTIPLECAUSESAN INTEGRATED APPROACH IS NEEDED!
Analysis based on 2016-2017 Romanian data
7 3 2
Case study
ProductsFive MarketAuthorization Holderspresent in the country.
Not availableSeven equivalent brandedproducts never launched inthe country.
Not accessibleThree products notaccessible due to
commercial issues.
Not accessibleTwo products not accessibledue to manufacturing issues.
Temozolomid: used for brain tumors
8
Limited quantitiesEight products from two MaH are availableonly in limitedquantities.
823
Parallel traded823 units parallel traded in the first half of 2019.
20
1 1
Case study
ProductsTwo MarketAuthorization Holderspresent in the country.
Not availableOne branded product neverlaunched in the country.
Not accessibleOne branded product not
accessible due tocommercial issues.
Bleomycin: used in Hodgkin limphoma & others
2
Parallel tradedNot parallel traded.
0
Available Accessible
Internal PricingManufacturing
External Pricing
Supplychains
ParallelTrade
Guidelines Procurement
HTA
Data Transparency
At least 1 year notificationprior to a product'sdiscontinuation or
withdrawal.
MANDATORYNOTIFICATIONS
Monitoring availablestocks at least at
regional level.
STOCKS
Notification ofquantities and
destination of paralleltraded products.
PARALLELTRADE
Defining alertthresholds to identifyrisk of shortages for
specific products.
ALERT LEVELS
Public shortages reporting (signals) from patients or healthcare professionals
WHAT SHOULD BE DONE?Aim high
Revamp EU Pricingmethodology
European HTASpecial rules for essential medicines Rules enforcement
NEED TO ACT
NOW!
