Parallel Imports of Pharmaceuticals: Evidence from Scandinavia and Policy Proposals for Switzerland
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Find out more. Request archive. Editorial enquiries. As a leading Swiss corporate law firm, we advise and represent enterprises and entrepreneurs in all aspects of commercial law — transactions, proceedings and complex cases both in a domestic and a global context. View more information about Homburger. Peter J Levitas. Oliver Borgers. Totis Kotsonis. Eversheds Sutherland. Alan M Klein. The comprehensive range of guides produced by GTDT provides practitioners with an extremely useful resource when seeking an overview of key areas of law and policy in practice areas or jurisdictions which they may otherwise be unfamiliar with.
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I do believe that GTDT has a real future and, according to me, it's one of the best legal database I've ever had access to in these last 10 years. Free access. Buy Softcover. FAQ Policy. About this book Parallel trade occurs if international price differences for identical products are high and a policy of regional or international exhaustion of the respective property right has been implemented in the high price country.
Parallel Imports of Pharmaceuticals
Table of contents 9 chapters Table of contents 9 chapters Introduction to parallel trade Pages Parallel trade of pharmaceuticals in Norway Pages Parallel trade of pharmaceutical drugs in Denmark Pages Parallel imports of pharmaceutical drugs into Sweden Pages Increasing payers benefits from parallel trade: Observations from Scandinavia and policy proposals for Europe Pages Why do prices not converge?
Other Online Sources. Innovative pharmaceutical companies have rapidly invented new medicines to fight against chronic conditions and notorious diseases such as AIDS that have plagued the worldwide population. While there are legitimate arguments to both sides on whether the increase in drug prices is a necessary evil,  no one can dispute the burdens it places on poor populations. Even in the United States, many Americans have resorted to filling their prescriptions with drugs from foreign countries. This research guide will focus on legal and economic factors surrounding the global problem of gaining access to innovative drugs.
This discussion is necessary to understand the obstacles against providing access to essential drugs despite the compulsory licensing provision that was passed specifically for that purpose: to help provide essential drugs to those that could not otherwise afford them. The analysis will then consider reasons that support and oppose expanding the compulsory licensing provision to hurdle those obstacles.
Patents and medicines: The WTO must act now!
The analysis will show that the benefits of providing essential medication outweigh the risks of lost capital gains and counterfeit drugs. Finally, the research guide will cite several solutions that have been suggested by others and propose further research on their feasibility. Prior to , intellectual property law and international trade policies were essentially separate entities that were very limited in force and scope. Trade negotiations revolved around tariff and trade barrier reductions.
The key in evaluating the policy trend of TRIPS in relation to the pharmaceutical industry is to look through the lens of its Article 7 objective to balance two competing interests: promoting innovation of new drugs and providing access to these drugs. It placed more emphasis on promoting innovation than on providing access to essential drugs, thereby favoring member nations that enjoy the majority of pharmaceutical innovation.
However, remedial measures to resolve conflicts from alleged abuse of the system remain vague. Particularly troublesome are the lack of specific requirements in determining eligibility for compulsory licensing, risks of arbitrage and production of counterfeit drugs, and whether TRIPS, in its current construction, will actually help developing countries gain accessory to essential drugs. On its face, the compulsory licensing provisions contain a number of vague terms that are intended to broaden the scope, but instead will most likely increase the transaction costs of assigning a valid compulsory license.
These ambiguities have been articulated by Vishal Gupta, who suggests some objective approaches in determining valid circumstances for compulsory licensing. The problem is that the scope of eligible diseases, drugs, and nations are undefined. A good example of this practice occurs between Canada and the United States. The general consensus is that pharmaceutical arbitrage poses a danger to innovation because it undermines already-existing efforts to provide affordable drugs through differential pricing and reduces the revenue needed to keep pharmaceutical research and development a profitable investment.
Still, this is currently the hottest topic for economists regarding whether providing access to drugs through compulsory licensing will have a detrimental effect on the market, and consequently hinder innovation—perhaps because the U. At the extreme is the view that legalizing re-importation of drugs into the U.
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Adding to the controversy is the lack of uniform rules for protecting the rights of patent holders. That is, TRIPS does not address whether patent rights are exhausted once patented products are sold into the market stream. For now, the WTO requires members who import and export pharmaceutical products under a compulsory license to send notice of the details of the transaction, such as name of the drug, name and address of the manufacturer, name and address of the importer, quantity, and duration.
A similar risk to arbitrage that is frequently included in compulsory licensing discussions is the production and export of counterfeit drugs with no therapeutic value. This is perhaps the most severe threat to public health as people will not be able distinguish a counterfeit drug by its physical appearance. Pharmaceutical companies argue that compulsory licensing with no clear standards against arbitrage will increase the probability that consumers in developed countries will inadvertently purchase dangerous substitutes in efforts to purchase cheaper drugs.
According to Outterson, however, empirical evidence tends to show that the threat of counterfeit drugs is overstated for several reasons. TRIPS now extends compulsory licensing privileges so that nations without manufacturing capacity can import drugs.
However, evidence suggests that this provision will fail in its efforts to improve access to patented drugs. Amir Attaran, an immunologist and lawyer, makes this argument based on history of compulsory licenses.
Evidence from Scandinavia and Policy Proposals for Switzerland
Many developing countries want to attract future investment and technology; therefore, they choose not to issue compulsory licenses because it might show a lack of respect for intellectual property rights and consequently decay trade relations or scare off investors.
Furthermore, if countries are reluctant to issue compulsory licenses for the benefit of their own people, it is even less likely that they will use this measure to assist another country that lacks manufacturing capacity.
Perhaps now that the Hong Kong Declaration permanently amended the compulsory licensing provisions, these concerns will become moot. In order to maximize their profits, companies across industries utilize differential pricing schemes, sometimes more generally referred as price discrimination.
Since the Implementation Decision was adopted in , the potential threat of compulsory licenses has moved companies to voluntarily make proactive efforts to realistically make their drugs accessible. Some have dramatically lowered prices while others have offered voluntary, royalty-free licenses. In contrast, many still argue that the compulsory licensing provisions have not helped bring drugs to those in need.
Some low-income nations like Thailand, Colombia, and South Africa have been pressured by powerful nations like the U.
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The emerging pattern tends to show that the leveraging capacity of compulsory licensing depends on the relative political strength of the licensing country. Considering the fact that most poor countries do not have political pull, it looks as though compulsory licensing and differential pricing negotiations in the near future will not make significant impact in improving access to medicine. The following subsections explore potential solutions to the issues with the current TRIPS amendment.
Each solution was proposed prior to the Hong Kong Declaration. While time may prove that some of these solutions are unnecessary, others deserve consideration despite the recent amendment. As mentioned in the prior section, the Hong Kong Declaration has left significant ambiguities that, though well intended, may impede efficient use of compulsory licensing. Clarifying these ambiguities will not only improve efficiency in utilizing compulsory licenses but may also encourage nations to issue compulsory licenses without concerns of political backlash.
The most common suggestion is to develop and maintain a set of lists that universally recognize diseases that can be considered a threat to public health and drugs that are automatically eligible for compulsory licenses. Another suggestion is for WTO to adopt a uniform socio-economic model to determine whether a nation is eligible to grant compulsory licenses. Adopting a model prevents abuse and ensures that not just any nation can use compulsory licensing to gain cheaper access to drugs.