The recommendations resulting from the recent review of VA technology transfer practices have just been released for publication.  NAVREF members will recall that last November Acting General Counsel Paul Hutter and Acting Under Secretary for Health Michael Kussman, MD, ordered the review which was conducted by Associate General Counsel Renee Szybala and Margaret Hammond, MD, chief consultant for the Spinal Cord Injury and Disorders Service within the Office of Patient Care Services at the Puget Sound VA Health Care System and professor at the University of Washington.

The recommendations are posted on the NAVREF web site at http://navref.org/newsletter/pdf/OGC_Decision_Memo.pdf along with a cover memo by Mr. Hutter and a joint Office of General Counsel (OGC)/Veterans Health Administration (VHA) “decision memorandum” to implement the recommendations.

NAVREF greatly appreciates the commitment of Dr. Kussman and Mr. Hutter and their staffs to work together to improve VA technology transfer program functions and the extraordinary effort Ms. Szybala and Dr. Hammond put into their review.  Ready acceptance and implementation of their recommendations attests to the effectiveness of this OGC/VHA partnership.

Many of the Review Team recommendations have already been implemented or are in process.  Key elements include:

1.       Reassignment of legal responsibility for technology transfer from OGC Professional Staff Group (PSG) IV to PSG Group III.  As noted in a previous NAVREF email, Ms. Szybala and Staff Attorney Patricia Watts are now responsible for technology transfer legal matters.

2.       Reconsideration of VA interpretation of the CRADA statute as the basis for re-examining and possibly revising VHA policy on intellectual property management. At this writing, the reconsideration is nearly complete and review of VHA policy will begin shortly.

3.       Increased Technology Transfer Program (TTP) staffing through temporary details and permanent new hires.  Assignment of personnel is in progress at this writing.

4.       Delineation of clear communication channels and processes among OGC, Regional Counsel and TTP as evidenced by the email sent last week regarding submission of CRADAs.

5.       Weekly PSG III and TTP staff meetings until tech transfer is back on track.  These have been occurring since January and have proven effective in fostering a productive working relationship.

6.       Clear delineation of TTP and OGC roles and responsibilities in regard to tech transfer.  This entails pending revision of the regulation delegating authority for tech transfer matters.

7.       Reconstitution of the CRADA Work Group, including TTP, OGC and NAVREF representatives, which has been meeting almost weekly since early February.  To date, the WG’s priorities are 1) developing a more user-friendly model CT CRADA that will be the basis for a bank of models for various situations; and 2) executing the first master CRADA with a major pharmaceutical company.

During the CRADA WG meeting this afternoon, the group decided to hold longer and more frequent meetings as needed to accommodate Mr. Hutter’s direction to quickly finalize key models and masters.   Everyone is pitching in so please stay tuned for updates!

Pasted below is the OGC email disseminating the decision memo to VA attorneys.  It is our understanding that a separate communication is being sent to VHA personnel.

From: Hall, Walter A., OGC
Sent: Thursday, March 22, 2007 3:48 PM
To: OGC RC's & Asst. RC's; OGC Nonprofit Corporation Panel
Cc: Hutter, Paul; Thompson, Jack H., OGC; Szybala, Renee (OGC); Hogan, Michael R. (OGC); McCallum, Deborah
Subject: Decision Memorandum to Implement the Recommendations of the Review of the Office of Research and OGC Working Relationship

From:   Assistant General Counsel  (023)
Subj:   Decision Memorandum to Implement the Recommendations of the Review of the Office of Research and OGC Working Relationship
To: Regional Counsels and OGC Nonprofit Corporation Panel Attorneys

1.  Attached is the Decision Memorandum that documents the decision of the Acting General Counsel and Acting Under Secretary for Health to adopt the recommendations of the review conducted by Dr. Margaret Hammond and Renée L. Szybala of the working relationship between VHA’s Technology Transfer Program (TTP) and Professional Staff Group IV (PSG IV).  (I’ve also included a copy of the cover memo from Paul Hutter to Dr. Kussman.)  On December 15, 2006, Dr. Hammond and Ms. Szybala reported their findings and recommendations to OGC and VHA management.  At the meeting, the Acting General Counsel and the Acting Under Secretary agreed to adopt their recommendations.  Attached are the memorandum memorializing this decision and a copy of the recommendations.

2.  As you can see, the recommendations are extensive.  They are largely the responsibility of the program, but OGC, both in the field and CO, will be called upon to provide assistance and support.  The Acting General Counsel has previously communicated his decision to realign responsibility for OGC support for TTP in CO from PSG IV to PSG III.  Both PSGs are now working to make that transition successful.  Within PSG III, the Technology Transfer subject matter has been added to the jurisdiction of Renée Szybala (023C).  We have had the good fortune be able to bring Patricia Watts on board to be our lead staff attorney on this issue.  Pat will be backed up by Jane Gutcher, another attorney new to PSG III.  A number of your offices have already dealt with this new team on ongoing CRADA and other tech transfer issues.  We will be fully engaged and responsive. Technology Transfer Program issues are now a high priority for our staff group.

3.  A decision memo on OGC’s reconsideration of the law of tech transfer will be issued in the near future.  New policy decisions may result and require implementation through revised guidelines and models.  The drafting and implementation of new written procedures to govern the process is also called for by the recommendations.  These tasks will require OGC support and input to TTP, and full collaboration between our PSG and your offices.

4. We look forward to working closely with you on the implementation of these recommendations and on technology transfer issues.   Please contact Renée if you have any questions.

Walter A. Hall
Assistant General Counsel (023)
Department of Veterans Affairs
(202) 273-6334
walter.hall@va.gov