The second quarter of 2009 saw steady progress toward healthcare reform in the United States and action in
several of the world’s other major pharmaceutical markets to curb pharmaceutical expenditures. Cost-containment
strategies vary considerably from one country to another, but governments and other payers increased their
emphasis on strategies such as increased use of generics, price cuts, and health technology assessment (HTA).
Questions Answered in This Report
President Barack Obama has declared his intention to pass healthcare reform legislation in the United States
before the end of 2009. What are the key features of legislation under review by Congress? How much
would healthcare reform cost? What are the implications for the pharmaceutical industry?
The European Court of Justice (ECJ) recently issued two judgments that could have signifi cant repercussions
for drug manufacturers. How much freedom do European governments have to impose price cuts
or freezes on prescription drugs? Can generics manufacturers use drugs licensed many years ago in
recently acceded EU member states as reference products for abridged applications for generic drugs?
The German government has earned a reputation for strict control of healthcare costs. What changes are
pending for certain widely prescribed cardiometabolic drugs? What barriers to market access will new
drugs likely face in the future?
The Japanese government has recently begun preparations for a new round of pricing and reimbursement
reforms in 2010. What is the government considering with regard to the regular price revision process?
What are the prospects for long-listed drugs subject to generics competition?
Scope
Issues affecting the pharmaceutical industry in the United States: healthcare reform; pharmacy
benefit management trends; comparative effectiveness research; regulatory pathway for biosimilars;
flexible pricing arrangements.
Issues affecting the pharmaceutical industry in Europe: market trends; generic drug use; health
economic evaluation; proposed prescribing and reimbursement restrictions; shifting patterns of parallel
trade; flexible pricing arrangements.
Issues affecting the pharmaceutical industry in Japan: disagreement on pricing reform; continued
resistance to the use of generics; approval of the first biosimilar.
Outlook and implications for the pharmaceutical industry: potential impact of U.S. healthcare
reform; increased focus on cost cutting; potential impact of the recession on healthcare spending;
continued growth of generics markets; challenges for biosimilars; market access barriers for new
drugs; prescribing and reimbursement restrictions; growth of flexible pricing arrangements.
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