Canada's Government threatens to outlaw drug exportation to the United States - Read More in Pharmaceutical Pricing, Reimbursement, and Regulatory Affairs News in the Fourth Quarter of 2004.

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c31597) has announced the addition of Pharmaceutical Pricing, Reimbursement, and Regulatory Affairs News in the Fourth Quarter of 2004 to their offering.

What impact will the re-election of George W. Bush to the U.S. presidency have on the pharmaceutical industry? How is the role of generics expanding and influencing pharmaceutical industry dynamics?

In this report, we review these and other developments in the fourth quarter of 2004 in the areas of pharmaceutical pricing, reimbursement and regulatory affairs. It focuses on measures that health care payers are using to curb their drug expenditures and improve patient access to medications. We conclude with an assessment of the outlook and implications for the pharmaceutical industry.

Business Implications

--In the United States, pressure to legalize drug importation has been mitigated by the reelection of President George W. Bush, a critical report from the Health and Human Services task force on drug importation, and a threat by the Canadian government to outlaw drug exportation to the United States. However, Congress may yet force through legislation to legalize this trade.

--The Centers for Medicare and Medicaid Services (CMS) is beginning to introduce participation in health economic trials as a condition for Medicare reimbursement of costly treatments and diagnostic procedures. CMS is particularly interested in ensuring that its spending on expensive cancer therapies and diagnostic procedures is cost-effective, suggesting that the agency will take a much tougher approach to coverage decisions in the future. Managed care organizations may take their lead from CMS.

--In Germany, the inclusion of certain patent-protected drugs in the same reference pricing groups as off-patent medicines beginning January 1, 2005, has prompted several companies to take legal action. Pfizer has refused to cut the price of Sortis (atorvastatin), the best-selling drug in Germany, to reference price levels. In addition, AstraZeneca has indicated that the extension of reference pricing might prompt it to abandon its plans to launch Crestor (rosuvastatin) in Germany in 2005.

--The Spanish government has recently published a new Strategic Plan for Pharmaceutical Policy. Pending the creation of a new reference pricing system, the government will cut the prices of all drugs that have not been subject to reference pricing by 4% in 2005 and by 2% in 2006. The Medicines Agency will set up a new committee to evaluate new drugs' "therapeutic utility" and to compare their cost-effectiveness with that of existing therapies. Spain's pricing and reimbursement system will be adapted to take greater account of medicines' degree of innovation and their value for money.

--The U.K. government has made renewal of the Pharmaceutical Price Regulation Scheme (PPRS) conditional upon a 7% cut in overall prices for branded prescription drugs. This measure is expected to save the National Health Service (NHS) a total of GBP 1.8 billion ($3.3 billion) over the five-year duration of the new PPRS. However, the government has increased the allowance for R&D and granted manufacturers several other important allowances.

Contents Include:

Overview

--United States

--European Union

--France

--Germany

--Italy

--Spain

--United Kingdom

--Japan

Outlook and Implications for the Pharmaceutical Industry

List of Figures:

Figure 1. Annual Changes in Average Usual and Customary Prices for Branded and Generic Drugs Frequently Used by Medicare Enrollees in Pennsylvania and New York 

Figure 2. Quarterly Drug Imports from Canada to the United States

Figure 3. Comparative Pharmaceutical Expenditures of Germany's Statutory Health Insurance System in 2003 and 2004

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