Prospects for Legalizing Drug (Re-)Importation to the United States
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President Barack Obama said during his election campaign he would ‘allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the US’. He began delivering on this promise with a fiscal 2010 budget request for funds ‘to allow the FDA to begin developing policies for drug importation’. Earlier in 2009, with strong bipartisan support, Senator Bryon Dorgan (D-ND) re-tabled a bill to allow both personal and commercial drug importation. Obama himself, new White House Chief of Staff Rahm Emanuel and the influential Senator Edward Kennedy were co-sponsors of the identical 2007 version. The new HHS Secretary, Kathleen Sebelius, signed up to a state importation programme when Kansas governor, and has now committed to implementing one at the federal level should the law change. With public and private payers across the country seeking to save every healthcare dollar to get through the economic recession, Dorgan senses a ‘bit of a tailwind’ behind his proposal this time. His supporters are tackling their critics head on with claims that rather than it being dangerous the measure will actually improve drug safety. Through a legislative manoeuvre, and the help of former presidential hopeful Senator John McCain (R-AZ), Dorgan has obtained a commitment from the Senate Majority Leader to bring his bill to the Senate floor for a vote later in 2009. Drug importation is back on the front burner. Is your company prepared? The report addresses: • What is proposed in the Pharmaceutical Market Access and Drug Safety Act of 2009. • Personal and commercial importation in perspective. • Answers to the key questions: Will the bill pass and when? If it passes, will it work and how soon? Where might supplies come from and how? Who would buy and use imported drugs in the US? What are the risks? What would be the savings? • How Canada’s international pharmacy business developed. • Comparison with parallel trade in Europe You’ve heard the sound bites, get the facts and analysis from an acknowledged expert on cross-border trade and international online pharmacy. Whether you want to protect your business in the US, assess the potential for becoming a player in what could be a new channel or a supplier to it, or are concerned about the knock-on effects in the 20 countries initially named as potential sources (inc. Australia, Canada, France, Germany, Italy, Japan, Spain and the UK) this report is essential reading. Table of Contents : Executive Summary 1. Background to Importation 1.1 Healthcare Coverage in US 1.1.1 Employers 1.1.2 Medicare 1.1.3 Medicaid 1.2 US Drug Prices 1.3 Cost Burden 1.4 Why Importation? 1.5. Current Legal Situation with Importation 1.5.1 Importation by Manufacturers 1.5.2 Enforcement Discretion with Personal Importation
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