The article reflects on the state of play as regards access to non-summary clinical trial data in the EU. In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information – the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs and the interests at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA’s policies.
Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted? by Daria Kim :: SSRNFebruary 6, 2017
The market for pharmaceuticals is not perfect. But competition and public opinion generally ensure that high prices and profits don’t persist for long. The recently enacted 21st Century Cures Act should help by speeding up FDA drug approvals, making competition even more effective.
Biologics, the most effective medications used to treat chronic debilitating autoimmune diseases such as Rheumatoid Arthritis, are also the most expensive, even for those with top shelf insurance. Biosimilars, which replicate biologics through the use of similar living organism extracts, will impact biologics’ American sales — biosimilars are generally much cheaper than biologics. Legal scrutiny in the biologic/biosimilar arena has focused on the Amgen versus Sandoz litigation, market share, and the biosimilar FDA approval process, established through the Biologic Price Competition and Innovation Act. Less coverage has been devoted to state-level battles over biosimilars. States have considered how biosimilars should be named, even though there is FDA guidance on the issue. Many state laws impose patient and physician consent requirements on insurance companies or pharmacists that seek to substitute biosimilars for biologics, even though the FDA does not require any additional action once an interchangeable biosimilar is exchanged for a biologic. This essay will consider whether state laws are impeding biosimilar market access, addressing how the laws have been marketed as “patient-friendly” legislation. Finally, it will propose how to involve patients at the state legislative level so that patient needs are heard and met.
High Prices in the U.S. For Life-Saving Drugs: Collective Bargaining Through Tort Law? by Paul J. Zwier :: SSRNJanuary 25, 2017
Sudden exorbitant price hikes to patients who have long taken life-saving drugs are more and more common in today’s pharmaceutical market. The anxiety caused to patients who have been prescribed these drugs by their doctors is predictable and severe. Even when initially covered by insurance or through government programs, patients and their families can soon be made destitute by the high copays or caps on payments. This Essay argues that those who buy up life-saving drugs and decide to raise their prices, despite their knowledge of the consequences to patients, are committing the torts of intentional infliction of emotional distress and negligent infliction of emotional distress.
Despite challenges presented by class certification law, these patients should be allowed to qualify as a class for purposes of pursuing a price reduction in these drugs. Through class action collective bargaining, courts can avoid the pitfalls of waiting for piecemeal legislation for consumers of individual drugs and still receive the advantages of free market principled pricing through collective bargaining. And, in combination with legislation, patterned on statutes designed to address bad faith insurance practices, the courts can most effectively moderate high pricing and curtail pricing practices that may otherwise soon bankrupt our-healthcare system.
Theory and Methods in Comparative Drug Policy Research: Response to a Review of the Literature by Scott Burris :: SSRNJanuary 21, 2017
Comparative drug policy analysis (CPA) is alive and well, and the emergence of robust alternatives to strict prohibition provides exciting research opportunities. As a multidisciplinary practice, however, CPA faces several methodological challenges. This commentary builds on a recent review of CPA by Ritter and colleagues to argue that the practice is hampered by a hazy definition of policy that leads to confusion in the specification and measurement of the phenomena being studied. This problem is aided and abetted by the all-too-common omission of theory from the conceptualization and presentation of research. Drawing on experience from the field of public health law research, this commentary suggests a distinction between empirical and non-empirical CPA, a simple taxonomic model of CPA policy-making, mapping, implementation and evaluation studies, a narrower definition of and rationale for “policy” research, a clear standard for measuring policy, and an expedient approach (and renewed commitment) to using theory explicitly in a multi-disciplinary practice. Strengthening CPA is crucial for the practice to have the impact on policy that good research can.
This study examines the patterns and causes of shortages in generic non-injectable drugs (e.g., tablets and topicals) in the United States. While shortages for injectable drugs have garnered more attention, shortages of other forms of prescription drugs have also been on the increase. In fact, they follow a strikingly similar trend with a number of important tablet drugs having recently been affected by shortage. This poses important questions about the root causes of these trends since most explanations found in the literature are specific to generic injectable drugs. Using a simple heuristic framework, three contributing factors are explored: regulatory oversight, potential market failures in pricing/reimbursement, and competition. This paper features an empirical examination of the contribution of changes in regulatory oversight to drug shortages. A pooled dynamic regression model using FDA data on inspections and citations reveals a statistically significant relationship between FDA regulatory activity (inspections and citations) and drug shortage rates. This result cuts across both injectable and non-injectable drugs, and could reveal a transition in equilibrium quality that should be transitory in nature, but it should also be interpreted with care given the other factors likely affecting shortage rates.
Drug prices are in the news. “Pharma Bro” Martin Shkreli increased the price of Daraprim, a treatment for fatal parasitic infections, by 5000%. Mylan found itself on the hot seat for raising the price of the anaphylaxis-treating EpiPen 15 times in 7 years, resulting in a 400% increase to more than $600. Politicians rail about the harms of high drug prices.
What can the next Administration do? A lot. This article shows how — even without directly regulating price — it can use antitrust law to reduce prices by challenging an array of anticompetitive behavior. It can target settlements by which brand drug firms pay generics to delay entering the market. It can go after “product hopping,” by which a brand firm switches from one version of a drug to another to forestall generic competition. It can target distribution restrictions that brands have instituted to block generics. And it can challenge other conduct in the industry. In short, antitrust law has a vital role to play.
Antitrust is about competition, which lowers prices and increases choice. Consumers in the pharmaceutical industry suffer harms as directly in this setting as anywhere. High drug prices have resulted in patients not being able to take vital medicines or splitting pills in half. To add insult to injury, this anticompetitive behavior typically is not justified based on innovation or patents. The agencies in the next Administration have important tasks ahead of them in targeting conduct in the pharmaceutical industry.