Recent media reports rightly point to Canada’s abysmal record when it comes to transparency of pharmaceutical data; this notwithstanding numerous calls and recommendations for urgent action, including in a 2012 Standing Senate Committee on Social Affairs, Science and Technology Report. A recent announcement by Health Canada that it was publishing a ‘summary report’ of data about the controversial acne pill Diane-35 (6 months after it announced it would do so) does little to reassure that we are really catching up with other countries. I will contrast here briefly two very recent European legal and regulatory ‘victories’ for trial transparency, but with some caveats about how industry may already be looking for new ways to limit access to pharmaceutical safety and efficacy data. Both in Canada and Europe, it appears more than ever important to emphasize that access to drug safety and efficacy data is not about weighing two ‘equally valuable’ interests (patient and consumer interest in accessing data against business interest in secrecy), but that these data constitute public goods; that access to relevant health information is essential for the exercise of health-related human rights and for publicly accountable and rational health funding decision making; that industry's request for data secrecy should therefore be firmly rejected; and that states have a human rights obligation to contribute to reliable knowledge production. Canada should follow Europe’s lead with respect to data transparency, but public health and patient advocates here as well as elsewhere should consider consolidating transparency gains with human rights based arguments, in light of undoubtedly continuing efforts to limit data access.
But first the good news from Europe. The European Parliament adopted last week (April 2, 2014) a new Clinical Trials Regulation, which includes obligations to register clinical trials prior to recruiting human subjects and to make the results publicly available. The same day the company Abbvie withdrew two legal challenges of the European Medicines Agency’s (EMA) data release decisions related to its controversial product Humira, which were pending before the European General Court. Both developments are significant victories for a widely supported campaign to promote transparency of drug safety and efficacy data. The transparency provisions in the clinical trials regulation builds on a panoply of earlier measures taken by national and international agencies and organizations to counter epidemic levels of misrepresentation and fraud within pharmaceutical industry controlled science. These industry practices have not only affected the well-being and lives of thousands of patients. It and will contribute to more reliable and independently evaluated drug development and funding. The recent exposure of the lack of convincing efficacy data on the massively stockpiled drug Tamiflu shows yet again how hiding and misrepresentation of data also leads to billions of dollars of waste in public and private health care spending. (See here and here for an overview of developments of trial registration and here for a detailed historical discussion of the rationale for transparency measures and an analysis of legal arguments made in the context of the transparency debate).
AbbVie’s decision to withdraw the legal challenge is also a positive development since it removes a reason for the EMA to be ‘conservative’ with respect to specific data disclosure requests—at least if the other company (Intermune) challenging a data access decision in the European General Court follows its lead. But if Intermune will follow Abbvie’s lead, we may at the same time lose an opportunity to get a judicial confirmation of the public health and human rights-based rationale for transparency and a clear judicial rejection of industry’s perverted use of human rights claims against transparency. AbbVie’s decision may in that regard not just be a public relations effort (it doesn’t look good to continue challenging a policy if a democratically elected body is sending the opposite signal), but also aim to avoid the damage of a potentially negative court decision. Leaving the outcome in limbo is better than having a strong judicial rejection of industry arguments. Industry strategists are now likely putting all their energy in more pernicious behind the scene lobbying. And there is a reason to be concerned about that. As a consortium of civil society groups led by The Commons Network and including Health Action International and the Society of Drug Bulletins recently reported in a Joint Position document, the pharmaceutical industry is putting pressure on European and US trade negotiators to enter an industry wish-list with serious implications for public health protection into the final text of the Transatlantic Trade and Investment Partnership. Reducing clinical trials transparency is only one of the problematic measures that may come out of these trade negotiations, which are conducted in secrecy and with a troubling lack of democratic input. Canada and Europe recently concluded a political still to be ratified agreement on free trade that may contain similar transparency restricting measures. One of the reasons why the recently announced improvements to the Canadian drug regulatory system fail to contain any transparency measure may perhaps be related to this trade agreement.
The European Commission also recently introduced a draft directive on trade secrets in the European Union. It is not clear yet what the implications could be for clinical trials data, and the new Clinical Trial Regulation may provide a buffer against any attempt to capture clinical trials data under those provisions. As many authors such as Jerome Reichman have argued, clinical trials data should be considered ‘public goods’. These data only exist because of a public regulatory requirement that has historically been introduced to strengthen the level of information available prior to regulatory approval. Data with such overwhelmingly clear public purpose should not be treated as trade secrets (even if, admittedly, many clinical trials appear to have become marketing tools rather than a reliable assessment of safety and efficacy).
The secret trade negotiations and ongoing efforts to reclassify clinical trials data as commercial secrets through regulatory and statutory initiatives would make it particularly useful to obtain a legal confirmation of the human rights dimensions of transparency in a European court. A human rights based reasoning in favour of data access, which I developed in two recent papers (see here, and here with Candice Telfer for a more detailed discussion, including of the normative justification), seems even more important because the pharmaceutical industry itself has invoked human rights to make exactly the opposite argument—i.e. that it has some kind of human rights interest in data secrecy—and it has had some preliminary success with this argument in interim proceedings that took place in 2013 in the context of the legal challenges against EMA's data access decisions.
In these interim proceedings, lawyers for the companies challenging the access decisions argued not only that clinical trials data are commercial secrets, and should be protected by governments under the TRIPS agreement (see here again for a rejection of the TRIPS argument), but also that EMA’s public data disclosure violated the companies “right to the protection of private and family life,” a right guaranteed under the European Convention on Human Rights and the European Charter. (The argument was indeed based on the privacy rights of the company in the data, not the privacy rights of patients who participated in the clinical trials—which has also been invoked by industry and industry-supported patient advocacy groups.)
Surprisingly, the president of the General Court appeared impressed enough by the human rights based argument that he agreed in two interim judgments in April 2013 (here and here) to suspend EMA’s disclosure decisions. Framing it as a human rights issue was key for his decisions. Indeed, to obtain a temporary suspension of the data disclosure awaiting the final decision, the companies had to overcome a double hurdle. They had to show that the claims had a reasonable ground in fact and in law. The idea behind this ‘prima facie’ assessment is that frivolous claims should not lead to immediate suspension of governmental actions, which benefit from a presumption of legality. For this ‘prima facie’ assessment, courts basically assess whether there is a reasonable basis for the claim and whether there is a likelihood of success for the party making the claim in the final decision. A second hurdle was that the harm to the ‘rights’ invoked resulting from the regulatory decision (here data disclosure) should be irreparable and irrevocable, so that if a final decision is in favour of the companies, no adequate compensation could be provided. This is where the human rights argument comes in. Lawyers for EMA had reasonably argued that if the court would conclude in the end that EMA’s disclosure had violated the companies’ rights, the court could order financial compensation for the harm suffered. Not so, ruled the president of the court, if it is a violation of a fundamental right to privacy; in that case, he ruled, the harm is inevitably irreparable.
That kind of reasoning makes sense with respect to many violations of human rights, including also a more traditional human-being-associated privacy right. The harm resulting from announcing someone’s HIV status in the media, or publishing intimate details about a person’s private life, are hard to rectify with financial compensation after the facts. Financial compensation also can never truly restore the harm caused by human rights violations such as torture or a violation of the right to life. But the harm suffered by the disclosure of clinical trials data that convey some form of commercial advantage to companies is clearly not in the same league. Yet, the President of the General Court failed to make this distinction.
The interim ruling based on a privacy-rights characterization of clinical trials data secrecy seems even more extraordinary in light of the case-law from the European Court of Human Rights that supports exactly the opposite claim: that access to important health and safety-related information is an essential component of, among others, the right to the protection of private and family life and the right to life. This human rights dimension of data access, which we analyzed in the earlier mentioned papers, was clearly completely ignored by the President of the European General Court. The President simply concluded that the interest of EMA in providing data access could not have been so substantial in comparison with the interest of the companies in the privacy of data, since EMA introduced data disclosure only recently. No discussion is found in the interim judgment about the importance of data access to protect the public.
The President’s suspension of data access was a clear victory for industry. It immediately impacted on data access decisions by the EMA. The agency became concerned that any company could now be inclined to challenge the decision in court and obtain an interim injunction against individual data access decisions. The fact that major trade organizations had obtained intervener status in the case reflected that this was a very likely outcome.
But industry’s victory was short-lived. EMA lawyers emphasized in the appeal procedure in front of the Vice-President of the European Court that the harm to the company could always be compensated should the court conclude in the final decision that the EMA did not have the right to disclose the data. And with a reference to the pharmaceutical governance and human rights paper, they also pointed to the human rights dimensions of data access, rejecting the claim that the company had a commercial secrecy interest in the data that could be qualified as a right to the protection of private life.
In his appeal decision, Vice-President Lenaerts of the European Court stuck to a careful narrow analysis of the legal arguments of the President’s interim decision. He did not have to enter into a discussion of the legitimacy of the companies’ claims and the nature of the rights at stake, but he pointed out that it was incorrect to conclude that if companies have a fundamental privacy right over their clinical trials data, disclosure of these data inevitably creates a risk of serious and irreparable harm. Even if these rights would be fundamental rights, the Vice-President wisely ruled, they are not of the same nature as other fundamental rights, such as the prohibition of torture or inhumane and degrading treatment, and financial compensation could very well rectify the harm. The companies would have to show that it would be impossible to calculate the level of financial harm they would suffer as a result of disclosure in order to have the potential harm qualified as irreparable.
The appeal decision thus rejected the interim suspension, but did not discuss the precise nature of the interests of disclosure versus the interests of the companies. This is something that would have been a key issue in the final decision, which could eventually have ended up in front of the European Court of Justice. The withdrawal of the case thus takes away an excellent opportunity to see how a court would deal in a fully reasoned decision with the in my view human rights perverting argument that the secrecy of clinical trials data deserves protection as a fundamental right to the protection of private life of pharmaceutical companies. We will also miss an opportunity to obtain a strong affirmation in court of the contrary argument put forward by the EMA lawyers that access to clinical trials data should be seen as part of a fundamental right to privacy.
The European interim proceedings highlight why civil society groups should start emphasizing the human rights dimensions in the context of the transparency debate. If they don’t, industry will, and for quite opposite reasons. Human rights claims have been successful both as rhetorical and as litigation tools in the context of access to essential medicines. It is time to move it to the forefront of the debate over access to pharmaceutical data. This may not only be essential in the context of future litigation. It will also help bolster the claim that secretly conducted trade negotiations should not be allowed to undermine the human rights associated interests in data transparency.
