Midterm - Health planning and regulations

Midterm - Health planning and regulations - 1 Djamila...

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1 Djamila Oliveira Health Planning and Regulations Prof. Laflamme Mid Term Examination Friday, November 19, 2010 S. 334: AN APPROACH TO DRUG IMPORTATION Senator Enzi started the statement saying that he believe it may be possible to import prescription drugs from other countries and do so safely, but they do need to answer a lot of questions before they can open their borders to imported drugs without endangering consumers or jeopardizing research and development of new, lifesaving products. He also talked about how earlier in the year, he promised that they would have a hearing within 90 days, and how it was within that time period. That was the third hearing the committee had held on drug importation that year in an effort to ask and answer the important questions. It is also mentioned on the hearing that a lot of patients choose to import prescription drugs because they can’t afford the local price, although the senator replied by saying that he was sure that all of the witnesses would agree that a counterfeit or tainted drug is unsafe at any price. As they consider the issue of drug importation, the safety of the citizens must be their primary concern. In my opinion, the issue of importation is intertwined with the potential for counterfeit drugs, and several considerations regarding this issue deserve attention. First, drugs used in the United States and Canada are manufactured around the world. Second, many of the counterfeiting issues focus around entry, not at the consumer level, but at the manufacturing or wholesale level.
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2 Finally, counterfeit medicines are not a local or single-country problem, but a global issue. Safety of the medicine supply, therefore, cannot be taken for granted. Fundamentally, drug safety is not an importation issue, but instead a highly complex problem of international regulation and necessary harmonization. To effectively address issues of safety, and by the same token, counterfeits and importation, there must be a closed distribution chain without a gray market, electronic tracking and trace security features must be implemented, and tougher penalties and better enforcement of sanctions against counterfeiters must be put into place. Governments must act now to effectively implement self-help measures to make counterfeiting as difficult as it is in the world of currency.46 In addition, the pharmaceutical drug industry must realize its role in protecting the public against counterfeit drugs. Finally, the punishment must fit the crime; counterfeiters should be subject to stiff penalties and substantial fines, as well as an
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Midterm - Health planning and regulations - 1 Djamila...

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