sergio napolitano ega director legal affairs and trade · example: inhalers – asthma & copd...
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The generics environment today Sergio Napolitano
EGA Director Legal Affairs and Trade
2 October 2015, Warsaw
EGA Membership
SPMA
(Slovenia)
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L A
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(Hungary)
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EBG Membership C
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EGA Vision 2020
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To provide sustainable access to high quality
medicines for all European patients
EGA Vision 2020
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Evolution of EGA Structure
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Europe: a global hub for high-quality
generic and biosimilar medicines
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European Countries with
generic medicines R&D and
manufacturing*
European Countries with
manufacturing sites of EU
approved biosimilars**,
under development and
under evaluation*
Source: *EGA Internal data - **EMA EPARs
Generic Medicines
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Generic medicines – A cornerstone
of healthcare sustainability
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Without generic medicines
drug bills would be
€40 BN more in the EU
More than
350 manufacturing sites
employing over
160,000 European citizens
Generic medicines account for
55% 21% of dispensed of pharmaceutical
medicines expenditure
7% of turnover to
R&D
exporting to more than
100 countries outside the EU
One of the
Most
Competitive
Sectors in
Europe
Benefits of generic competition in
the off-patent sector
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GENERIC COMPETITION
Widely used well-established medicines
LOWER COST
Price competition or payer driven
price reduction mechanisms
INCREASED PATIENT CHOICE
Competition increases available
presentations of a product
MORE ACCESS TO
MEDICINES
More patients treated for
less money.
ENABLES INNOVATION
Enables reimbursement of
innovative and value-added
medicines
Generic medicines enhance access to medicines,
reducing inequalities, directly leading to
improved patient outcomes
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Hypertension treatment EU 28 (2013)
Diabetes treatment EU 28 (2013)
82 million treated patients
48 million treated by generic medicines
59% generic medicines share
36 million treated patients
20 million treated by generic medicines
54% generic medicines share
Source: Euro Barometer; BMC Public Health – Internal estimate based on IMS MIDAS
In chronic disease areas, patient access to
treatment has doubled, while spending remains flat
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Evolution in seven therapy areas
Last 10 years (2005 – 2014):
>100% increase in prescription volumes
>50% decrease in price of medication per treatment day
Selected therapy areas: angiotensin II antagonists, anti-epileptics, anti-psychotics, anti-ulcerants, cholesterol regulators and oral anti-diabetics.
Use of generic medicines post-patent expiry acts
as a balance for the expenditure of new products
Ageing population: Major EU social
and economic challenge
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Ageing population and poor lifestyle will increase demand for medical services and pharmaceuticals
Europe ageing population forecast to 2050
Selected therapy areas: angiotensin II antagonists, anti-eipleptics, anti-psychotics, anti-ulcerants, cholesterol regulators and oral anti-diabtetics.
Usage of generic medicines has increased…
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31% 33%
35% 37%
39% 41%
43% 44% 46% 47%
49% 51%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
CAGR: +5%
Generic medicines market share by volume (2001-2012)
Source: IMS MIDAS Market Segmentation Data 12 Months to 2012 (2012)
But still room for increased generic penetration to
further increase access for patients
72.9% 68.9%
66.0% 65.6%
60.0% 57.0% 55.6% 55.0% 54.8%
52.5% 52.3% 51.3% 49.9% 49.1% 47.8% 44.3% 43.5%
40.6% 38.8% 37.5%
27.3%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
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Need to introduce demand-side policies to maximize
savings and foster a competitive and sustainable supply
Source: IMS MIDAS mat June 2014, Rx Retail market
Generic medicines market share by volume (June 2014, total Rx retail market)
~3x
Sustainable pricing policies
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A focus on cost-containment leads to:
Decreased competition & increased costs
Concentration of suppliers & shortages
Decreased patient access
Europe must set long-term, sustainable pricing policies to guarantee supply
Demand side policies targeting patients, pharmacists, physicians
Supply side policies which avoid short-term cost-containment measures
Biosimilar Medicines
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Biosimilar medicines: Key facts
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Biosimilar medicines: Key facts
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+55% of biosimilar medicines used worldwide
are produced in Europe
2007-2020 :Cumulative savings for 8 EU
Countries up to 33.4 b€*
By 2018, half of pharmaceutical expenditure
will come from biologicals**
Strong R&D investment in Europe - biosimilar
medicines – present in 14 member states
Source: * IGES study - **Prime Therapeutics & University of Minnesota College of
Pharmacy, poster presented at AMCP San Diego April, ***EGA internal data
Since 2006, EU approved biosimilar medicines
have generated more than 400 million patients
days of clinical experience worldwide***
The increase in Biosimilar
medicines’ use
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Biosimilar medicines increase
patient access
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Biosimilar Filgrastim : 72% of volume, more than 10% increase in patient access
Biosimilar filgrastim: 30% more patient access to “gold standard” earlier in Europe
Biosimilar Filgrastim : 83% volume, 44% increase in patient access
A sustainable national policy
framework should cover:
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1. Education and information
2. Incentivisation of appropriate early use
3. Collection of Real World Evidence (RWE)
4. Transparent and evolutionary procurement
Value Added Medicines
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What is a Value Added Medicine?
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Known molecules which deliver significant
improvements and address unmet needs for:
Patients, payers and/or health care professionals
Added value may be created thanks to:
Better health outcomes
Quality of life
Improved tolerability
Better adherence
Less dosing frequency
Reduction of medical errors
Any other innovative solution
Value added medicines are different to
generic medicines
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Considerable time & costs associated with R&D
Costs 100x higher than standard generics
Regulatory uncertainty
No guarantee of market exclusivity
Higher commercialisation risk
Larger Sales & Marketing investments (e.g. HCP training)
Slower uptake
Value Added Medicines:
An Opportunity for Europe
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Example: Pre-filled Syringes
• Convenient System
• Reduced re-constitution steps – Ready To Use, Economical
• Reduced risk of contamination – Safer working environment
• Reduced risk of needle stick injuries with Leur-Lock systems
• Reduced risk of errors / mix-up of reconstituted medicines.
• Ideal platform for emergency medicine in OT settings
Example: Inhalers – asthma
& COPD • Adherence rates are lower
than other chronic
conditions1
• Total annual cost of
unscheduled events due to
poor inhalation technique:
£18.8 million/year2
1Hansen R et al. Transplant Proc 2007;39(5):1287–1300 2Lewis A et al. Poster (36700) presented at The International Society For Pharmacoeconomics and Outcomes
Research (ISPOR) 19th Annual International Meeting in Montreal, QC, Canada, 31 May–4 June 2014
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EGA - Legal Affairs
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Double dimension: public health & IP
Quality
EGA engagement on counterfeit medicines
Active role with EU institutions
The work on trademarks
The EGA in the international arena
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International cooperation
IGBA – International Generic and Biosimilar Medicines
Association
EU, US, Canada, Japan, Jordan, South Africa, Taiwan, Mexico,
Australia, Brazil
Fostering International Trade in Generic and
Biosimilar Medicines
Cooperation with all international institutions (WHO,
WTO, WIPO, ICH…)
Dialogue with IFPMA
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Regulatory cooperation
International regulatory cooperation
EU-US Transatlantic Trade & Investment Partnership
(TTIP)
Mutual recognition of GMP inspections
Single EU-US development for biosimilars & complex generics
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