The pharmaceutical distribution chain in the European Union: structure and impact on pharmaceutical prices

In an environment characterised by fragmentation in the market structure of wholesale and retail entities, significant diversity in terms of remuneration schemes as well as regulations pertaining to operational features of wholesale and retail entities, but also significant developments in policy and practice concerning distribution, the objective of this report, is twofold: First, to map the distribution chain in EU Member States, including the main actors in wholesaling and retailing, discuss the requirements to provide certain services and outline their sources of remuneration, both direct and indirect. Second, to collect and analyse data on distribution margins, fees and service requirements in the originator and generic markets in EU Member States with a view to understanding the impact the distribution chain is having on the prices of reimbursable prescription only medicines (POMs). The report does not address issues relating to over-the-counter (OTC) medications

Catching up in pharmaceuticals: a comparative study of India and Brazil

Since the mid-twentieth century, the national objective of India and Brazil has been to develop industrial capabilities in essential sectors such as pharmaceuticals. At the outset, they shared some common features: a considerable period of lax intellectual property rights regimes, large internal market and a reasonably strong cadre of scientists and engineers. However, over fifty years, India has had much more success in building indigenous capabilities in pharmaceuticals than Brazil, at least to date. Why? In exploring the answer to this question, we show that in both countries the design of State policy played a crucial role and the endogenous responses in the national system of innovation consisted of two parts. On the one hand, most of the time, the predicted and desired outcome was partially realized and on the other hand, there were invariably, other unpredicted responses that emerged. The latter unexpected elements, which were specific to the two countries, pushed them along distinctive trajectories.Pharmaceutical industry, India, Brazil, industrial capabilities, Catch-up

Catching up in pharmaceuticals: a comparative study of India and Brazil

Since the mid-twentieth century, the national objective of India and Brazil has been to develop industrial capabilities in essential sectors such as pharmaceuticals. At the outset, they shared some common features: a considerable period of lax intellectual property rights regimes, large internal market and a reasonably strong cadre of scientists and engineers. However, over fifty years, India has had much more success in building indigenous capabilities in pharmaceuticals than Brazil, at least to date. Why? In exploring the answer to this question, we show that in both countries the design of State policy played a crucial role and the endogenous responses in the national system of innovation consisted of two parts. On the one hand, most of the time, the predicted and desired outcome was partially realized and on the other hand, there were invariably, other unpredicted responses that emerged. The latter unexpected elements, which were specific to the two countries, pushed them along distinctive trajectories.Pharmaceutical industry, India, Brazil, industrial capabilities, Catching up, Technology transfer

Pharmaceuticals Delivery in Ireland. Getting a Bigger Bang for the Buck

Ireland

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have called for the generic firm to neither challenge the brand-name company’s patents nor sell a generic version of the patented drug for a period of time. In exchange, the brand-name drug company agrees to compensate the generic firm, often with substantial monetary payments over a number of years. Because the payment flows counterintuitively, from the patent proprietor to the accused infringer, this compensation has been termed a “reverse” payment. Commentators have differed markedly in their views of reverse payment settlements. Some observers believe that they are a consequence of the specialized patent litigation procedures established by the Hatch-Waxman Act. Others have concluded that when one competitor pays another not to market its product, such a settlement is anti-competitive and a violation of the antitrust laws. Since 2003, Congress has required that litigants notify federal antitrust authorities of their pharmaceutical patent settlements. That legislation did not dictate substantive standards for assessing the validity of these agreements under the antitrust law, however. That determination was left to judicial application of general antitrust principles. Facing different factual patterns, some courts have concluded that a particular reverse payment settlement constituted an antitrust violation, while others have upheld the agreement. Congress possesses a number of alternatives for addressing reverse payment settlements. One possibility is to await further judicial developments. Another option is to regulate the settlement of pharmaceutical patent litigation in some manner. In the 111th Congress, S. 369, the Preserve Access to Affordable Generics Act, would establish a presumption that certain reverse payment settlements are unlawful. S. 369 then establishes relevant factors to be weighed in deciding whether that presumption has been overcome through a showing that the procompetitive benefits of the settlement outweigh its anticompetitive effects. This report will be updated as needed

Paying for Delay or Something Else?--The Potential Anticompetitive Effect of Reverse Payment Patent Settlements in the Pharmaceutical Industry under article 101 TFEU

This thesis discusses the recent hot topic in the intersection of IP law and competition law; “pay-for-delay” agreements in the pharmaceutical industry. Such agreements arise in patent disputes where originator manufacturers (‘Originators’) claim patent infringement by the generic manufactures (‘Generics’). However, patent infringing defendants end up paying the plaintiff large sums of money, accompanied with the generic’s agreement to delay or refrain from challenging the patent and launching generic drugs. Due to the fact that the parties may have agreed to not compete by sharing monopoly profits, pay-for-delay deals could lead to an artificially higher market price which detriments consumer welfare. Whether all suspicious pay-for-delay deals are anti-competitive has been controversial in the academic field and the courts in the US. As the EU has only recently started its study and investigations into the issue, it is worthwhile to study: whether such deals are anti-competitive in themselves, to what extent they could be anti-competitive under the EU competition law and how should they be examined to reach the optimum result for competition law implementation. Section 1 of this thesis will firstly give a general picture of the history of pay-for-delay deals in EU and US. Section 2 will further offer the legal context and the industry features that fertilize the emergence of pay-for-delay deals. Section 2.5 summarizes the change of attitude of US courts and the investigations in Europe. Through studies into the judgement/decisions of these cases, Section 3 proposes a system of classification for pay-for-delay, which puts pay-for-delay deals into high-risk, medium-risk and low-risk categories. The rationale and method of such classification will also be included. The thesis ends with the conclusion that not all the agreements that meet the superficial criteria of pay-for-delay agreements (restriction on generic entry and reverse value transfer) are of anti-competitive effect. Some may be the reasonable result of a genuine patent dispute and will not leave anti-competitive impacts on the market. It is thus necessary to classify these agreements by their level of anti-competitive risk and that they should be scrutinized differently in accordance with the classification they fall into

Is It Possible to Have Cheaper Drugs and Preserve the Incentive to Innovate: Reforming the Drug Approval Process According to Market Principles

This paper argues that drugs are expensive not because of a lack of competition among research-based pharmaceutical companies, but because of a lack of competition in the drug approval process. Lack of competition in the drug approval process has led to exceedingly high drug development costs. High drug development costs combined with artificially low drug prices, obtained through price control legislation and legislation that eases the entry of generic products into the market, has caused lower levels of pharmaceutical research and development, innovation, and economic growth.Privatization, Competition, Monopoly, Innovation, Drugs, Generics, Pharmaceuticals