sustainable competition - government.bg · eu: longest protection period worldwide for 86 molecules...

patients • quality • value • sustainability • partnership

Sustainable Competition:the Magic Formula to Align Public Health and Business

Objectives for Access

Adrian van den HovenDirector General

Medicines for Europe


Medicines for Europe Vision 2020 Our 5 pillars

PARTNERSHIP

PATIENTS

Me

dic

ine

s Fo

r Eu

rop

e

VIS

ION

QUALITY

VALUE

SUSTAINABILITY


Medicines for Europe - Structure

The challenges and opportunities for EU


An ageing populationMajor EU social and economic challenge

129 million patients

2014

191 million patients

2050

+50%Population

over 65 years

Modern lifestyle and an ageing population increase prevalence of chronic disease

Population Structure by Major Age GroupsEU28, 2014-2080 (percentage of total population)

15,6 15,0 15,1

65,956,9 56,2

18,528,1 28,7

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2014 2050 2080

65+ years

15-64 years

0-14 years

Source: Eurostat Population Statistics


New medicine costs impacting budget

Source: IMS Health, 2016

5%4%

8%

15%

10%

EUR 0

EUR 10

EUR 20

EUR 30

EUR 40

EUR 50

EUR 60

EUR 70

EUR 80

EUR 90

2012 2013 2014 2015 2016

Bill

ion

s

EU Sales (Protected Brands)

New brands (<2Years)


EU pharmaceutical sales

EUR -

EUR 20

EUR 40

EUR 60

EUR 80

EUR 100

EUR 120

EUR 140

EUR 160

EUR 180

2012 2013 2014 2015 2016

Bill

ion

s

EU sales

Generics

Unprotected Brands

Protected

Source: IMS Health, 2016

High volume, low cost medicines treating large primary care diseases for

the first time

The first disease-modifying specialty

treatments

Niche indications

The latter decades of the 20th

century

2000 2010 the emergence of targeted therapies driving enhanced value and cost benefit

Since 2010 increased focus on significant areas of unmet need and rare diseases with no effective remedies

400 million global patients

35 million global patients

AVERAGE PREVALENCE

Notes: Prevalence and Annual cost were categorised into estimated buckets; annual cost takes into account list price at time of launch.

Source: QuintilesIMS Thought Leadership Launch Excellence I and V

Innovative specialty medicines now are targeting smaller populations with significant unmet needs

Generic Medicines


Generic medicinesA Cornerstone of Healthcare Sustainability

Opportunities to increase uptake

Protected and off-patent marked share (volume) by country, June 2015

Source: IMS Health, MIDAS, Q2 2015, retail and hospital channel

Note: Non-original brands and branded generics include copy products in some countries; Generics include INN branded and company branded

Biosimilar Medicines


Biosimilar MedicinesA Cornerstone of Healthcare Sustainability

Historically biosimilar competition restricted but the future is very different

Autoimmune20%

Oncologics20%

Antidiabetics9%

Erythropoietins4%

Hematopoietic Growth Factors

2%

Growth Hormones2%

Rituximab

Trastuzumab

Adalimumab

Etanercept

Infliximab

Insulin glargine

Historically 8% of biologics exposed to

biosimilars

Top Biologic Therapy Areas, Europe sales (2016)

Source: QuintilesIMS MIDAS MAT Q3 2016; Europe excludes Russia and Turkey

Access to biological treatments varies greatly European among countries

0,61

0,23

0,12

0,53

0,09

0,06 0,04

0,00

0,10

0,20

0,30

0,40

0,50

0,60

0,70

Anti-TNF Infliximab Etanercept Epoetin HGH Fertility GCSF

TD/C

apit

a Bulgaria

Romania

Poland

EU average

Source: IMS Health, Generics and Biosimilars Report, 2016

Biosimilar medicines increase patient access

Change in # of treatment days(2016 vs. year before biosimilar entrance) HU RO PL EU

Epoetin -9% -38% +237% +7%

G-CSF (filgrastim) +209% +2542% +146% +58%

Growth hormone (somatropin) -9% +152% +82% +48%

Anti-TNF (infliximab & etanercept) -6% +12% +7% +26%

Fertility (follitropin alfa) +46% - +45% +10%

Source: IMS Health, Generics and Biosimilars Report, 2016

Value Added Medicines


Value added medicinesRethink, reinvent & optimise medicines

Medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and or payers

Definition

Improvements


Value added medicinesRethink, reinvent & optimise medicines

How

What’s in it for


Market AccessMarket Access

Priorities

Education and information for

healthcare professionals and patients

Support prescription of

generic and biosimilar medicines

Reduce timelines and

uncertainties in patent

opposition procedures

Accelerate the timelines for pricing and

reimbursement

Avoid extreme pricing models

Prohibit linkage of IP to MA and

P&R

Why are there shortages of multisource medicines?

REGULATORY COSTS AND PRICE PRESSURE

ABILITY TO SUPPLY IS NEGATIVELY

AFFECTED BY

REGULATORY COMPLIANCE COST

• GMP / GCP /…

• Variation Regulation

• PV regulation

• FMD

PRICE

• Price cuts

• Tendering

• External Reference Price

• Claw-back

PATIENTS • QUALITY • VALUE • SUSTAINABILITY • PARTNERSHIP

EXAMPLE OF PRICE PRESSURE

ROMANIA: 2000 MEDICINES WITHDRAWN!

• External reference pricing and clawback tax reduce access tomedicines

• European Commission (DG ECFIN): ‘Joint Report on HealthCare and Long-Term Care Systems & Fiscal Sustainability’

“While overspending is recovered via the claw-back tax (…), it

has led to withdrawals of generic medicines from the

market”.


CREATINGAND MAINTAINING

A MULTI-SOURCEMARKET

MORE MANUFACTURERS

= LESSSHORTAGES

PREVENT SHORTAGES

• Improve regulatory efficiency to reduce administrative and cost burden of keepingproducts in the market

• Ensure market predictability

• Address negative impact of parallel trade

• Manage available market stock information

MITIGATE SHORTAGES

• Specific measuresto mitigate imminent shortage



Sustainability of healthcare systemsdriven by sustainable competition

better procurement of medicines for

generic, biosimilar and value-added

medicines

improved pricing & reimbursement policies of off-

patent medicines

increased uptake of biosimilar

medicines

market stability & predictability

Off-patent competition brings sustainability to healthcare systems

cost-efficiency and patient access

there are additional opportunities to stimulate competition


The importance of pharmaceutical manufacturing

• Medicines supply: 62% of Rx medicines (2016) rising to 75% (est.2020)

• High skill jobs: 190.000 direct jobs/450 sites across Europe. New complex technology plants (biotech, complex value added) & dense SME network.

• R&D: 126 R&D sites. Pharmaceutical R&D is connected to manufacturing technology proximity.

• Export opportunities: EU technology & medicines sought after worldwide (eg. Biosimilar, value added, complex formulations)

• EU security: How much reliance on foreign production?


The Supplementary Protection Certificate (SPC)

• Patent protection: 20 years

• Supplementary Protection Certificate (SPC): extends exclusivity of patented products by up to 5 years

• Compensates for Marketing Authorisation delays in Europe

• Generic & Biosimilar medicines companies cannot produce for commercial purposes where SPC is in place

• Unintended effect:

EU manufacturers forced to outsource in order to market in unprotected territories


EU: longest protection period worldwide

For 86 molecules out of 107 analyzed protection expires in EU last

Sources: Medicines for Europe Company Members

D I S E A S E M O L E C U L E S E X P I R Y D A T E S

EU USA KOREA CHINA INDIA CANADA

Cancer (kidney) SORAFENIB 21/07/2021 12/01/2020 17/09/2020 12/01/2020 12/01/2020 13/01/2020

Cancer (Leukaemia, gastro

intestinal, etc) IMATINIB 21/12/2016 04/07/2015 03/06/2013 02/04/2013 NA 01/04/2013

Cancer (lung, pancreas) ERLOTINIB 21/03/2020 08/05/2019 30/10/2016 28/03/2016 13/03/2016 06/06/2015

Cancer (mostly breast) PERTUZUMAB 23/06/2025 15/07/2025 23/06/2020 23/06/2020 NA 23/06/2020

Cancer (renal) SUNITINIB 24/07/2021 15/02/2021 15/02/2021 15/02/2021 Revoked 15/02/2021

Cancer (renal) TEMSIROLIMUS 14/04/2020 15/08/2019 14/04/2015 14/04/2015 NA 14/04/2015

Cancer bone BAZEDOXIFENE 16/04/2022 04/04/2017 14/12/2018 18/04/2017 NA Expired

Cancer collateral effects FOSAPREPITANT 28/02/2020 04/03/2019 Rejected 28/02/2015 Expired 28/02/2015

Cancer colon AFLIBERCEPT (ZALTRAP) 01/02/2028 02/12/2025 02/12/2025 02/12/2025 02/12/2025 02/12/2025

Cancer lung AFATINIB 12/12/2026 22/01/2022 09/02/2026 12/12/2021 12/12/2021 12/12/2021

Cancer lung GEFITINIB 04/03/2019 05/05/2017 01/12/2016 23/04/2016 19/04/2016 25/04/2016

Cardio disease DRONEDARONE 06/08/2011 26/07/2016 08/09/2015 Expired Expired 24/07/2011

Cardio vascular PRASUGREL 27/02/2019 14/10/2017 24/12/2013 09/09/2012 NA 08/09/2012

Cardiovascular (blood clots) RIVAROXABAN 02/10/2023 28/08/2024 03/10/2021 11/12/2020 11/12/2020 11/12/2020

Cardiovascular diseases IVABRADINE 25/03/2018 25/09/2012 Expired Expired Expired 25/09/2012

Chemo collateral effects APREPITANT 13/05/2019 17/04/2015 16/12/2016 13/12/2014 NA 13/12/2014


SPC manufacturing waiverWhere are we?

• EU-Canada Trade Agreement (CETA) (Sept 2014)

• Introduces patent extension in Canada• Allows export waiver (Canada introduced it)

• EP Resolutions call for SPC manufacturing waiver to stimulate competitiveness of EU industry• on re-industrialising Europe (Jan 2014 – Butikofer)

• on IPR protection in non-EU countries (June 2015 - Mosca)

• on Single Market Strategy (May 2016 – Comi)• on Access to Medicines (Feb 2017 – Cabezon Ruiz)

• Commission Single Market Strategy - 28 Oct. 2015• Proposes SPC manufacturing waiver

• Publication of Charles River Associate Study – 5 Oct 2017• 25.000 additional direct jobs

• €9.5 billion net sales for EU pharma industry

• €3.1 billion savings to EU pharma spending

• Commission Public Consultation – 12 Oct 2017/4 Jan 2018


The EU needs an

SPC manufacturing waiver

Europe needs to increase competition and supply of medicines.

Europe needs thousands of Jobs & Economic Growth.

High skill pharmaceutical R&D and manufacturing should be back into the EU.

Need for rapid introduction of an SPC Manufacturing Waiver!


Thank you

sustainable competition - government.bg · eu: longest protection period worldwide for 86 molecules...

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