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Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify - Product Image

Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify

  • ID: 1667962
  • March 2011
  • 107 pages
  • Datamonitor
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Healthcare expenditure is growing fast in all markets, driven by aging populations, a growing prevalence of chronic diseases, expanding government healthcare coverage, use of expensive drugs. Also, as a result of the economic downturn, healthcare funding is under increased scrutiny by governments in developed markets looking to pay down their debts.

Features and benefits

- An overview of healthcare expenditure in the 12 major markets
- Insight into the major reforms of healthcare systems in the developed and developing markets
- An assessment of the regulatory issues that are affecting global pharma markets.
- Analysis of the key pricing and reimbursement controls that are affecting pharma


- As a result, healthcare reforms in EU and Japan focus on containing costs, without impacting quality of service. Ongoing measures include pricing and reimbursement cuts, bolstering generic usage, as well as other cost cutting tools, with the outcome largely negative for branded pharma.
- Although the US health reform law may well result in extended health insurance coverage and increase government involvement in healthcare, costs READ MORE >

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Executive Summary
Strategic scoping and focus
Key findings
Key growth drivers and resistors facing healthcare payers and pharma
Healthcare expenditure
Healthcare reforms
Regulatory issues
Pricing and reimbursement
Related Reports
Upcoming related reports
Healthcare expenditure is growing fast
There are several factors driving up healthcare expenditure across the markets analyzed:
The proportion of public contribution to healthcare is greater in the developed as compared to the emerging markets
However, despite improving economies, the emerging markets like the developed markets, are under pressure to contain costs, leading to implementation of strategies such as price cuts that are impacting pharma companies operating in such markets.
Pharmaceutical expenditure is increasing in all markets
Healthcare reforms focus on improving access and cutting costs
The main aim of healthcare reforms in the EU and Japan is to contain costs
France is reforming hospital management to reduce costs
Germany is transferring cost of healthcare onto individuals to rein in spending
Italy has been engaged in a raft of healthcare reforms
Spain’s recent healthcare reforms have focused on pricing and reimbursement issues
UK primary care trusts will be phased out
An aging population has necessitated cost-containment measures in Japan
Healthcare reforms in emerging markets will positively impact pharma
Key aims of healthcare reforms in emerging markets include the following:
India plans to expand healthcare services
Healthcare continues to be a priority for Brazil’s government
Russia rolls out its 2020 healthcare plan
China is making strides in improving health insurance coverage
Healthcare reforms in the US will largely have a neutral impact on pharma
Healthcare reform has already had an impact on pharma in
Will the healthcare reform law be repealed?
Potential impact of healthcare reform on pharmaceutical sales
Healthcare systems globally are converging towards a similar model
Closes payer-pharma relationships set to evolve
Disease management will become central to payer decisions
Pharma will need to manage both patient and payer expectations
Several key markets are decentralizing healthcare decision-making to increase efficiency
UK’s decentralization strategy has raised concerns regarding inequality of access to healthcare services
Italy has already devolved many powers to regions causing inequality in access to care and treatments
Brazil, Russia, and China are also engaging in decentralization strategies
Regulatory changes have a largely negative impact on pharma
Heightened safety concerns continue to impact pharma
Collaboration between the FDA and EMA is intensifying
EU ban on direct-to-patient communication guidelines partially relaxed
Developed markets exhibit a stable intellectual property environment
It is generally easier to secure patent protection in the US than in the EU
The EU follows the 8+2+1 rule
Japan gives branded pharma companies 8 years of data exclusivity through re-evaluation requirement
Springboarding allows generics manufacturers to access branded drug data in Australia
Loss of Plavix exclusivity in Germany is thought to be an exception
The EU’s move to a single patent has been held up
The intellectual property environments in the emerging markets are seen as inadequate
Russia’s intellectual properly environment is characterized by corruption
Patent reviews are slow in Brazil
Indian law does not contain statutory data protection
China is not yet affording adequate data protection for new chemical entities
Key global pricing and reimbursement controls
Pricing controls
Reimbursement controls
Pricing and reimbursement cuts were key elements included in austerity measures in many developed markets
Patent-protected drugs are spared by Italian price cuts but off-patent and generic drugs suffer
Austerity measures in France impact both prices and reimbursement rates
Spain’s price cuts impact both branded and generic medicines
Germany’s new law focuses on containing the growth of spending on patent-protected drugs
Australia’s changing reimbursement landscape puts pressure on local generics sector
Japan continues to focus on drug price cutting as its main cost-containment measure
US pharma companies are impacted by higher rebates and discounts, but escape Medicare drug price negotiation
Pharma shows a strong reaction to price cuts in certain markets
Pricing pressures are also felt in the emerging markets
Brazil is widening free access of drugs to patients
China introduces tighter pricing controls on foreign pharmaceuticals
Russia has increased its drug price controls
India threatens to expand drug pricing controls
Branded pharma adopts flexible pricing strategies to capture emerging markets growth
Raised cost-effectiveness barriers lead to reimbursement restrictions
The UK is a difficult market to access for expensive therapies
It is becoming increasingly difficult to obtain a high price for new drugs in France
Achieving premium drug pricing in Japan is difficult
Germany is using cost-effectiveness in its drug evaluations
Comparative effectiveness analysis is starting to be used even in the US
Risk-sharing is becoming a viable option for both payers and industry, particularly in Europe
UK is one of the leaders in risk-sharing agreements
Italy has a number of performance-based risk-sharing schemes for oncology drugs
Risk-sharing schemes are also appearing in the US but in a fragmented manner
Australia’s risk-sharing agreements lack transparency
Risk-sharing agreements with individual sickness funds are used to boost market share in Germany
Price negotiation may be the way of the future
Value-based pricing in the UK to be introduced in
Germany introduces drug price negotiation
Publications and online articles
Datamonitor reports
Exchange rates used in this report

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