Category: Intellectual Property

Big Data, Predictive Analytics, Health Care, Law, and Ethics

I. Glenn Cohen Leave a comment

Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper in the volume entitled “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care” that has just been released. Ironically the article is behind a paywall (while data wants to be free, I guess big data is different!) Here is the abstract.

Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.

I will also have a related paper on mobile health coming out later this summer that I will blog about when it comes out…

REGISTRATION OPEN: 9/18 conference on post-trial access

The Petrie-Flom Center Staff Leave a comment

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014

Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.

This event is free and open to the public, but due to limited seating registration is required. Please register online.

Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.  Areas that currently lack clarity include:

  • What types of interventions or resources should be included within post-trial responsibilities?
  • What is a reasonable duration for post-trial responsibilities to extend?
  • What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?

This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.

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Profits or Drugs?

rbohrer Leave a comment

By Bob Bohrer

Cross-post from Pharmaceutical Policy

There were two stories in The New York Times that, although not directly related, are the basis for today’s post. The first, by Andrew Ross Sorkin, Do Drug Companies Make Drugs, or Money?,appeared in the Business Section on page B1 on June 3, 2014. The second, by Andrew Pollock, New System for Treating Cancer Seen as Hopeful, appeared on the same page of The New York Times on the same day. Sorkin’s provocatively titled article focused on Valeant Pharmaceutical International’s takeover bid for Allergan and on Valeant’s strategy, which Sorkin characterized as buying pharmaceutical companies with revenues produced by active and successful pharmaceutical research programs and then increasing profits by cutting back on R&D. Sorkin’s article, as the title indicated, posited a tension between focusing on rewarding investors with increased profits and investing in the development of new and innovative therapies. My purpose in highlighting Sorkin’s article alongside Pollock’s is not to take issue with Sorkin’s analysis of Valeant’s business strategy, but to respond to the article’s title question.  Read More

SCOTUS Embraces Regulatory Synergy in POM Wonderful

diwinter Leave a comment

By Diana R.H. Winters

While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful sued Coca-Cola under the Lanham Act, alleging that the label on Coca-Cola’s pomegranate blueberry juice was false and misleading, and that this deception caused it to lose sales. Coca-Cola argued that because its label complied with the Food, Drug, and Cosmetic Act, POM’s Lanham Act claim should be precluded. The district court and the Ninth Circuit agreed. Read More

Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

The Petrie-Flom Center Staff Leave a comment

By Timo Minssen

In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.

In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).

Following an invitation for public comments on this document, the EMA received more than 1,000 submissions from stakeholders. Based on these comments the EMA recently proposed “Terms of Use” (TOU) and “Redaction Principles” for clinical trial data disclosure.

In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. Read More

SAVE THE DATE: 9/18/14, Post-Trial Access to Medicines: Responsibilities and Implementation

The Petrie-Flom Center Staff Leave a comment

pills_genericvariety_slide

Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area.

Key questions include:

  • How should post-trial access be defined?
  • What type of interventions should be included in post-trial access obligations?
  • What are the responsibilities of various stakeholders?

More information, including the developing agenda, will be posted on the Petrie-Flom Center’s website as it becomes available.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

PFC_Logo_300x300MRCT

Summer Course for Professionals in “Pharma Law & Policy” at the University of Copenhagen

Timo Minssen Leave a comment

Stay abreast with recent developments and trends determining the legal and regulatory framework of the European pharmaceutical industry.

What are the most significant current issues shaking and shaping the pharmaceutical industry today? The business environment and legal framework relevant to the pharmaceutical industry continues to change rapidly in the face of constant challenges posed by competition, politics and technological innovation. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.

This course provides a broad and practical understanding of the ‘hot topics’ and will present and analyse these topics from scientific, legal and policy perspectives.

Further information about the course is available here.

Course content

The course begins with a general overview of the current scientific and legal trends in pharmaceutical R&D, organisation and policy. This is followed by a review of the hot topics through a combination of lectures, discussions, group work and case studies. The course is designed to allow room for the issues and challenges crucial to the participants’ daily work and practice.

Participants

The course is designed for professionals working with legal issues and/or regulatory aspects of drug development, decision-makers, administrators and health care practitioners within both the public and private sectors, e.g.:

  • Legal departments in the pharmaceutical industry.
  • Law firms dealing with patent and competition law in the pharmaceutical industry.
  • Branch organizations in the pharmaceutical sector.
  • Health care professionals and decision makers.
  • Bank and finance consultants working with risk and investment in the pharmaceutical industry.

Credit – especially for lawyers and trainee solicitors

This course meets the Danish requirements for compulsory supplementary training for lawyers and trainee solicitors.

Course dates

5 days, 18 – 22 August 2014, 9:00 – 17:00 at the University of Copenhagen, Frederiksberg Campus.

Course director

Timo Minssen, Associate Professor, Dr., LL.M., M.I.C.L., Centre for Information and Innovation Law, Faculty of Law, University of Copenhagen

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A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

Timo Minssen Leave a comment

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

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On Patents, Patients and the Public Interest

michaelyoung Leave a comment

By Michael Young

Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent.  After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards’ valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014).  Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.

While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.

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WEDNESDAY, 4/23: Reforming Brazilian Pharmaceutical Patent Policy

The Petrie-Flom Center Staff Leave a comment

Reforming Brazilian Pharmaceutical Patent Policy: Lessons from the Past and the Road for the Future

April 23, 12:00pm 

Wasserstein Hall 1010, Harvard Law School, 1585 Massachusetts Ave.

In this lecture by Pedro Paranaguá, he will discuss the report issued by the Brazilian House of Representatives in 2013 as part of an effort to revamp the country’s patent law. Brazil does not want to be a mere exporter of commodities, neither does it want to be a simple consumer of knowledge goods. Brazil wants to be at the cutting edge of innovation; it wants to innovate to compete. Paranaguá’s presentation will introduce the current state of affairs of the Brazilian patent system, with a focus on pharmaceuticals. He will present the main findings and recommendations of the 2013 report, including the tabling of a bill to fix the mistakes of the 1990s.  The talk will be followed by discussion with a panel of experts. Panelists include:

  • Brook K. Baker, Professor of Law, Northeastern University School of Law; Policy Analyst for Health GAP (Global Access Project)
  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

Pedro Paranaguá has been a Lecturer in Law at the LL.M. in Business Law at Fundação Getulio Vargas (FGV), Brazil, since 2007. Mr. Paranaguá is also the lead Advisor to the ruling Workers Party at the Brazilian House of Representatives for Internet, copyright, patent, data privacy, cybercrime, and related matters. He is responsible for drafting the Brazilian Internet Framework Bill (“Marco Civil”) for the rapporteur, including provisions on net neutrality, ISP liability, and privacy. He coordinated the 350-page report, “Brazil’s Patent Reform,” for the Brazilian House of Representatives. He has been an invited instructor at Duke University School of Law (2011), lecturer in law at FGV Rio, and has held numerous other lectureships in Brazil and abroad (Lecturer in Brazil and abroad (Brazil’s Supreme Court and Senate, Yale, UCLA, UNESCO, UNCTAD, WIPO). He was Director of the A2K Brazil Program at the Center for Technology and Society (CTS-FGV), and co-representative of Creative Commons in Brazil (2005-2010). He produced commissioned studies on copyright and technology for the country’s Culture Ministry, and served as FGV-delegate at the World Intellectual Property Organization (WIPO) in Geneva (2005-2009). He has also served as a member of the Brazilian Free Software Project. From 2001 to 2003, he was an IP lawyer at Gusmão & Labrunie, where he was Project Manager on patents and access to medicines. He is the author of the books Copyright Law (Portuguese) (with Sergio Branco) andPatent Law (Portuguese) (with Renata Reis). Mr. Paranaguá holds a LL.M. (cum laude) in Intellectual Property, Internet and Policy (London) and is a Doctoral candidate (S.J.D.) at Duke University School of Law, where he is finalizing his thesis, “Brazil’s Copyright Law Reform: Tropicália 3.0?”, under the supervision of Professor Jerome Reichman.

Sponsored by the HLS Brazilian Studies Association, with support from the Petrie-Flom Center.