EU Competition Law Enforcement: The Pharma Sector Inquiry

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Author: Lynne Myhre

Date: June 2009


Introduction

While antitrust laws in the European Union and the United States are similar, the rationale for enforcement of those laws, and the mechanisms for their enforcement, can vary considerably. The recent European Union inquiry into the pharmaceutical sector’s business practices provides a lens for examining how competition law operates in the EU.


Dawn Raids

Perhaps the starkest difference between EU and U.S. antitrust enforcement is the use in the EU of so-called “dawn raids” when competition violations are suspected, but evidence is lacking. On January 16, 2008, the headquarters of several pharmaceutical companies throughout Europe experienced surprise “dawn raids” by officials from the European Commission, the EU agency charged with enforcement of EU competition law.[1] The raids were not part of an official investigation, but rather an “inquiry” designed to ferret out information about business practices in the sector as a whole, and determine whether an actual investigation of individual firms was in order.[2]


In a dawn raid, a company must permit EC officials to take copies of any files or documents that might be relevant to the EC’s inquiry.[3] The information taken will help the EC decide if a full investigation should be opened. This is different from the U.S., where a search warrant must be granted by a court, and only when there is already evidence of wrong-doing. In the recent EU pharmaceutical sector inquiry, there was no evidence, only “indications that competition may not be working as it should be.”[4] The raids were not conducted in order to find evidence of wrong-doing by individual entities, only to determine how business practices in general were being conducted in the sector.[5] At the same time, however, any evidence of wrong-doing that is found during a dawn raid may be used to prosecute companies later.[6]


Defense Protections

While a search warrant is not required for an EU “dawn raid,” there are some limited protections for entities being investigated in this way. First, EC officials may not force their way into a company’s premises.[7] Typically, they wait until the business opens its doors in the morning, before entering.[8]


Second, while a court order is not necessary for a dawn raid at the EU level, searchers must still present documentation of the EC’s authorization for the raid, including information about its purpose and scope.[9] What is more, they must allow the company some time to contact legal counsel,[10] who will come during the raid to offer the company legal guidance, and even help to “shadow” the EC officials during their search, to prevent any improprieties.< Louis, Frédéric, et al. “EU Court Clarifies Limits on Legal Privilege in European Commission Investigations.” WilmerHale, Oct 9, 2007. Available at http://www.wilmerhale.com/publications/whPubsDetail.aspx ?publication=8046, 8 Jun 2009.</ref> Some law firms have developed specialized legal staff to assist clients during these investigations, and can respond in a comprehensive way at a moment’s notice.[11]


Third, an entity may refuse to hand over some documents for copying by the EC officials if the documents are privileged in nature.[12] Such refusal requires an entity to file a request with the European Court of Justice to block the EC’s request as it applies to the specific documents in question; an unfavorable decision can be appealed to the Court of First Instance.[13] The document is sealed in the interim, protecting it from both a breach of confidentiality by the EC, and from destruction or modification by the entity.[14] If the court decides that the document is not required to be kept confidential, however, the entity may be charged with obstructing the investigation.[15]


Some EU Member States, such as France, require that their own competition authorities obtain a court order before conducting a dawn raid.[16] During the EU’s recent pharmaceutical inquiry, French drug maker Sanofi Aventis refused to allow the EC to search its premises because the EC had not first obtained a court order from a French court.[17] The EC has since charged Sanofi Aventis with obstructing the investigation, and the matter is headed to an EU court.[18] It is not entirely clear whether EU or national law will prevail on this point.[19] If Sanofi Aventis loses, however, it faces fines of up to 1% of its 2007 annual sales.[20]


Why Dawn Raids

The EC conducts dawn raids during inquiries in order to gather as much complete and accurate information as possible. By surprising entities with the inspections, the EC prevents them from destroying, hiding, or altering many documents and files that could shed light on the issues being investigated.[21] Even though they are a surprise, the raids have always taken place after inquiries were well under way.[22] This time, however, the dawn raids occurred right at the beginning of the inquiry.[23] The EC felt the timing was necessary in order to determine if there was reason for a full-blown EC investigation.[24]


Inquiries are conducted when the EC has “indications” – but no solid evidence – “that competition may not be working as it should be in the sector concerned.”[25] The EC was careful to explain that the pharma inquiry, and dawn raids in particular, were not meant to search for evidence of wrong-doing.[26] However, if such evidence happened to be found, it could be used against any entities that the EC went on to investigate.[27] Regarding the inquiry into pharmaceutical sector, EC Commissioner Neelie Kroes cited a decline in new drugs, apparent delays in getting generic drugs to market, and patent litigation that seemed excessive, as indications that competition violations might be occurring in the sector.[28] The inquiry was begun in order to determine if the decline, delays and litigation were due to violations or to other reasons.[29]


During a dawn raid, the EC can take copies of documents and computer files, and can interview people at the company.[30] Company officials must assist the search through their files.[31] Any attempts to block access to the requested information, that cannot be sustained later in court, can be cause for charges of obstructing the inquiry.[32]


Next Steps

After the dawn raids on the pharma sector, the EC consulted with stakeholders in an effort to gain a better understanding of the situation.[33] Stakeholders included “industry associations at the European level: e.g. the European Federation of Pharmaceutical Industries and Associations (EFPIA) representing the originator companies and the European Generic Medicines Association (EGA) representing the generic companies,” as well as “representatives of consumer and patients associations, insurance companies, doctors, pharmacies, wholesalers, hospitals, parallel traders, patent offices and competition authorities.” The EC also sent questionnaires to many of the stakeholders, and solicited consultations from the public. At least 70 different agencies, businesses, law firms, individuals and organizations responded to the invitation to supply more information that would clarify their perspectives of the business practices of the pharmaceutical sector.[34]


After reviewing these initial documents, the EC issued a 426-page preliminary report that revealed that the dawn raids found solid evidence of anti-competitive actions taken by the companies that had been searched.[35] One company’s document declared that the “sole purpose” of at least some of its patents was to “[limit] the freedom of operation of our competitors.”[36] The EC also discovered that one drug maker had applied for up to 1300 patents on a single medicine, creating a significant burden for any firm to sift through in order to avoid violating any patents.[37] In addition, “originator” companies who developed new drugs had filed about 700 lawsuits against generic companies, delaying generic drugs’ entry in the market by an average of three years.[38] The originator companies had continued to file such lawsuits despite losing most of them, raising suspicions that the lawsuits were simply an abuse of the originator companies dominant position.[39] Brand-name drug makers and generic manufacturers had also engaged in anti-competitive patent settlements, documents showed.[40] The EC estimated that the various delays in getting generics to consumers had cost consumers and Member States at least €3 billion between 2000 and 2007.[41] The excessive litigation likely contributed to increased costs for drugs, and the decline in innovative drugs as originator companies focused on blocking competition rather than developing new medications may have harmed consumers as well.[42]


The initial inquiry and dawn raids provided a strong foundation for continuing the investigation. The EC next sought further public input and consults with stakeholders, and conducted even more dawn raids on November 24, 2008.[43] The EC planned to release a final report on the state of competition in the pharmaceutical sector in the summer of 2009.[44] The final report would likely provide recommendations on what actions should be taken next, such as opening investigations against firms who have engaged in anti-competitive behavior, or possibly changing some aspects of EU law to better support the needs of consumers, Member States, and the pharma industry.[45] Investigations may lead to injunctions to stop the violations, steep fines, or some combination of the two.[46]


Patents and Competition Law

One of the important findings of the EC’s preliminary report on the pharmaceutical sector was that dominant firms were abusing their positions in order to block the entry of generic drugs and other new drugs from market.[47] This abuse took several forms, including excessive patents on each medication, paying generic manufacturers to delay bringing their products to market, and excessive lawsuits designed to create delays in generic products.[48] Taken together, the behaviors of the dominant firms appear to have created a chilling effect on the development and introduction of new medications onto the market.[49]


Currently, each Member State in the EU has its own patent system. Both originator and generic drug companies agree that a single EU patent process, with a dedicated patent court, would help to improve the patent situation for all concerned.[50] Based on its findings so far, which also support a simpler, dedicated, single patent system, it appears likely that the EU may try to move in this direction.[51]


Public versus Private Enforcement

Generally speaking, competition complaints are filed with the EC or with Member States' Competition Authorities.[52] The relevant competition authorities then conduct inquiries or investigations, and may prosecute any companies found to be engaging in anti-competitive behaviors.[53] Depending on the country, suspected antitrust violators go to trial through courts or competition authorities, which then mete out fines or injunctions to those convicted. This is public enforcement of the criminal law, which is carried on and funded by the government, with the goal of protecting competitors and consumers.


While the system stops the behaviors through injunctions and penalties imposed on violators, competitors and others who were harmed by an anti-competitive behavior are not compensated for their losses through this system. The situation is made better going forward, but there is no public mechanism to reimburse victims for the damage that was already done.


Private enforcement plays a unique role in compensating victims for past harms because it allows victims to recoup their losses.[54] In the U.S., competitors who were harmed by anti-competitive behavior can sue for treble damages.[55] In the EU, however, when damages are available, they are generally only available for actual losses.[56]


Another difference between the two systems lies in who pays for the court costs. In the EU, it is customary for the losing side to pay the court costs of the winner. This means that if the plaintiff entity loses the case, it must still pay its attorney fees, PLUS those of the defendant.[57] This is designed to discourage frivolous lawsuits.[58] This introduces a real risk for potential plaintiffs, who also bear the burden of proof in each case[59] – and proof of anti-competitive behavior can be extremely difficult for plaintiffs to obtain on their own.[60] It is difficult for plaintiffs to compel the production of documents by defendants in most EU Member States.[61]


Plaintiff entities in competition law cases tend to be smaller and less-well-funded than the defendants.[62] A smaller firm’s financial position may have been further worsened by anti-competitive behavior by the defendant, such that the plaintiff has been prevented from earning the size of profit or market share it might otherwise have generated. The victim’s comparative lack of resources may add to the difficulty of presenting a strong case against a better-funded defendant. As a result, many genuine victims are deterred from seeking redress and private actions for competition violations are the exception, rather than the rule.[63]


To address this issue, the EU has encouraged the creation of more viable mechanisms for private actions in competition cases and has taken one step in this direction by allowing private plaintiffs to rely upon EU criminal findings as evidence in their cases.[64] It has also begun pushing member states to modify legislation in order to create civil causes of action where none now exist, and to increase access to civil litigation in all Member States for victims of anti-competitive practices. One way to make private actions more accessible is to expand or create pathways for collective actions, which the EU has also urged Member States to do.[65]


In the U.S., the defendant must pay the plaintiff’s reasonable fees and costs if the plaintiff wins the case.[66] Even if the plaintiff loses, however, the risks of litigation are relatively small because of the availability of contingency fees, where the plaintiff’s attorney is only paid if the plaintiff wins the case.[67] The attorney fees are then a certain percentage of the damages awarded to the plaintiff, generally ranging from 20-50 percent.[68]


Attorneys may make more money from individual contingency fee cases, when they win, than they might if they were paid on an hourly basis. This potential for a higher payment helps to offset the risks they shoulder by handling contingency fee cases, since they only get paid for the cases they win.[69] The risk of not getting paid if the case is lost encourages attorneys to carefully filter out cases that are unlikely to win, which serves to prevent some frivolous cases.[70] At the same time, however, because plaintiffs’ attorneys collect a percentage of any settlement, not just court judgments, they may be motivated to file cases in the hopes that a large entity will find it cheaper to settle than to fight the case in court.[71] It is sometimes in the defendant’s interest to settle a case quickly – and avoid the costs of a lengthy trial and negative publicity – even when a case has little merit.[72]


U.S.-style contingency fees are typically not permitted in the EU, although there are some mechanisms that are similar.[73] The United Kingdom, for instance, permits no-win-no-pay, which is similar to a contingency fee. In this system, attorneys may collect a percentage of the damages won, but are capped at double what they would have been paid for their time spent.[74]


Collective actions can facilitate private lawsuits by reducing costs, time and the burden on courts in situations where many plaintiffs are suing based upon the same set of facts. In the U.S., a class-action lawsuit covers everyone who fits into those facts, unless an individual opts out. Potential plaintiffs might want to opt out if they felt they could do a better job of pursuing their own case. When a case is certified as a class-action lawsuit, the plaintiffs’ attorneys stand to reap 20-50% of the entire award,[75] which can be huge when large numbers of plaintiffs are automatically included.


An opt-out collective action regime provides a strong incentive for attorneys to push for class-action certification whenever possible. The benefits are that court time and expenses are reduced for everyone involved, and the defendant needn’t worry about future lawsuits on the same issues. An opt-out class action can harm someone who did not opt out of the lawsuit, however, if the class of plaintiffs loses on a point that an individual plaintiff might have successfully proven.


In the EU, most countries do not have collective actions of any kind, much less for antitrust cases.[76] The few that do permit collective actions usually have set them up in a way that requires plaintiffs to opt in.[77] This prevents people from being involved in a case without their permission, and also eases concerns of encouraging too much litigation, as many Europeans believe has occurred in the U.S.[78]


Two other options that have been gaining some ground in the EU are representative actions, “which are brought by qualified entities, such as consumer or trade associations,”[79] and third party funding of civil litigation, where a third party pays the plaintiff’s cost of litigation in exchange for a percentage of the money recovered by the plaintiff.[80][81]


In addition to compensating victims, private actions also have the potential to increase the amount of anti-competitive practices that are brought to light, and to produce more of certain kinds of evidence required to successfully prosecute or correct violations.[82] According to an impact report prepared for the EC, victims often have more accurate and detailed information that the competition authorities.[83] Studies have also shown that when private enforcement increased enormously in the U.S., public enforcement remained stable and did not decrease.[84] Instead, a significantly more violations were caught after private enforcement became more common.[85] Better enforcement leads to a better business environment for competitors, and lower prices for consumers.


Leniency Programs

Leniency programs often produce the best evidence for an antitrust case, because the parties who take part in them have been personally involved in the illegal behavior.[86] However, to date, no company in the pharmaceutical sector inquiry has stepped forward to take advantage of a leniency program.[87]


Conclusion

Gathering thorough and accurate information is the first step in when the EC suspects an entity has enaged in anti-competitve behavior.[88] Dawn raids, while hard on entities, greatly increase the odds that the EC will be able to collect as much information as possible before it can be destroyed, hidden, or modified. Thorough information can inform further investigations against individual companies, but can also provide a basis for modifying laws to improve business climates and consumer welfare. For example, information uncovered in the pharma sector inquiry has led to serious discussions about creating a single patent system with a dedicated court might help to streamline the introduction of new drugs onto the market.


Private actions can compensate victims, and in doing so, can create an incentive for enhanced enforcement of antitrust law, which further serves to deter potential competition violations. While currently still rare in the EU, many Member States are beginning to remove barriers and create pathways for more effective civil litigation.


With the economic downturn, enforcing competition that keeps prices down may become a higher EU priority. Pharmaceutical companies, while accounting for only seventeen percent of health care costs, are an “easy target” for cost reduction measures and their business practices have been closely analyzed in recent EC inquiries. The desire to reduce costs while keeping a strong, innovative pharmaceutical sector may hasten much-needed changes in the EU’s patent and competition laws and its civil litigation mechanisms. These moves will benefit consumers in many areas beyond access to affordable medications.
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