Healthcare Captives Dealing with the "New Normal" in Healthcare
Dealing with regulations in the healthcare industry
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Transcript of Dealing with regulations in the healthcare industry
Dealing with regulations in the healthcare industryBaker & McKenzie European Pharma Meeting , 14.06.2013, Zurich
Thomas B. Cueni, Secretary General Interpharma
Agenda1. Today‘s main challenges for the industry
2. Patent settlement agreements (“Pay-for-delay”)
3. Inherent tension between national health policy (administered prices) and free flow of goods
4. Clinical trial data transparency
5. Compliance & HCP/HCO Disclosure Code
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Today‘s main challenges for the industry Policy and regulatory environment
Euro-zone crisis Single focus on cost-containment Missing growth agenda Market access delays Dogmatic competition law approach!
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Patent settlement agreements (PLSAs)
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PLSAs and “pay-for-delay” Conclusion of Commission’s Pharmaceutical Sector Inquiry (2009-2011)
seemed to be pragmatic Commission dropped certain previous investigations into pay-for-delay
cases in March 2012 due to lack of evidence (AstraZeneca) or withdrawal of the complaint by a rival company (GSK)
DG Competition is still investigating a number of PLSAs between pharmaceutical companies and generic manufacturers
Court decision in the first case is expected in June 2013 anti-competitive? abusive use? value transfer = restriction of competition “by object”? irreparable harm
legal uncertainty!
Patent settlement agreements (PLSAs)
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Patent rights encourage innovation and settlements of genuine patent disputes are generally efficiency enhancing PLSAs are by nature efficiency enhancing
Patent litigation in Europe is fact intensive, complex and often highly unpredictable litigation in multiple jurisdictions real risks of divergent outcomes
How to deal with generic competitors “launching at risk”? innovators have much to lose!
Case-by-case approach to assess PLSAs should be limited to: fraud in obtaining the patent no sham cases restrictions exceed the scope of the patent
Inherent tension between price control and free flow of goods
Conclusions from OECD study: International price referencing
is the most widely used approach (22/30 OECD countries) to cap prices (or reimbursement levels) of innovative medicines;
is perceived by public authorities as a means to assess the appropriateness of the proposed or actual price in relation to what is paid elsewhere;
requires an explicit or implicit notion about how pharmaceutical prices ought to differ across countries, and how they should be similar;
the rationale for selecting particular benchmark countries is not always explicit.
The use of IRP by EU member states and the pricing rule used
Source: CRA analysis. Note that international reference pricing is not applied to all products in every country. For example, in Germany it is only applied in particular circumstances.
FINLAND
AUSTRIA
ITALY
SPAIN
SWEDEN
NORWAY
GERMANY
FRANCE
PORTUGAL
HUNGARYROMANIA
BULGARIA
DENMARK
POLAND
U. K.
CZECH
SLOVAKIA
GREECE
ANDORRA
NETH.
BELGIUM
IRELAND
SERBIA
ALBANIA
LITHUANIA
LATVIA
ESTONIA
LUX.
MONTENEGRO
BOSNIA
CROATIA
SLOVENIA
SWITZERLAND
MACEDONIA
MediterraneanSea
NorthSea
AegeanSea
EnglishChannel
AdriaticSea
BalticSea
Helsinki
KrakowPrague
Bern
Hammerfest
Stockholm
Oslo
Copenhagen
Frankfurt
Berlin Warsaw
Vilnius
Riga
London
Dublin
Belfast
Paris
MadridLisbon
Barcelona
Milan
Rome
Naples
Venice
Bucharest
Budapest
CRETE
Athens
Geneva
Munich
Marseille
Bruxelles
Amsterdam
Belgrade
Vienna
Sarajevo
Tallinn
Zagreb
KEY:AverageLowestNone
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Problem has been acknowledged…
„…a similar price level leads to a different level of affordability depending on the economic situation of each Member State. Attention could be given to measures that allow companies to offer medicines at affordable prices in each EU market.“
„Member States are not interested in fixing prices of products that are only transiting through their territory to be utilised within other Member States. They should, therefore, abstain from fixing prices for products that will not be used within their territory and that will not impact on their national budgets…“
Source: Recommendation on P&R policies from High Level Pharmaceutical Forum
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…but short-term politics still prevail
Pharmaceutical policy making serves multiple objectives that must be balanced with one another to arrive at the policy mix that best reflects national priorities: affordable access to effective medicines vs. strong pressure for public
cost-containment; inherent trade-off between static and dynamic efficiency
static efficiency, in which consumer welfare is maximised by getting the most health value from today’s expenditures, as constrained by the limits of present technological capability
dynamic efficiency, in which the R&D incentives serve to generate growth in the capacity to prevent health conditions and cure diseases in the future.
Getting the best possible price or lowest possible expenditures for pharmaceutical products in the market today may mean having fewer and less innovative alternatives for the future.
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Static vs. dynamic efficiency
Inherent tension between price control and free flow of goodsFollowing ECJ Lélos Judgement of 16 September 2008 on the Greek
reference concerning quota systems (Cases C-468/06 to C-478/06) Companies even in they hold a dominant position must be in a position
to take steps (to limit parallel trade) that are reasonable and in proportion to the need to protect its own commercial interests
Judgments acknowledge right for companies to „protect their commercial interests“ – but there is no waivering yet from dogma of unhindered free flow of goods, or call to refrain from international price referencing
Revisit current legislative frameworkCJEU judgments give flexibility to companies – but don’t solve the problem
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Food for thought
Clinical trial data transparency Access to clinical-trial data
European Medicines Agency (EMA) announced that it will proactively publish clinical-trial data and transparency
Pharmaceutical industry recognises the need to establish a way forward
But how? A number of practical and policy issues need to be addressed before
complex data sets can be made available: rules of engagement good analysis practice last but not least: legal aspects
Principles for clinical trial data sharing PRIVACY: safeguarding the privacy of patients INTEGRITY: respecting the integrity of national regulatory systems INNOVATION: Maintaining incentives for research and innovation
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Compliance & HCP / HCO Disclosure Code
Increased regulation of interactions between pharmaceutical companies and HCP/HCOs at national level: Legal provisions: Denmark, France, Portugal, Slovakia Self-regulatory provisions: the Netherlands, UK Disclosure activities outside Europe: Japan, US (Sunshine Act)
Different approaches are in place at national level
EFPIA HCP/HCO Disclosure Code EFPIA brings together the 33 European national pharmaceutical industry
associations as well as 39 leading companies Much external focus on transparency, particularly related to the pharma
industries past-actions and also future commitments Monetary threshold on “Meals & Drinks” as well as prohibition of
“Gifts” Data Privacy Requirements must be checked at national level
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Interpharma, Petersgraben 35, Postfach, 4003 Basel, www.interpharma.ch
Thank you for your attention!