VII. Dealing with the bureaucracy

Government Laboratories are run on the basis of rules known as Government Regulations. Further, these regulations are evidently written under the assumption that government employees are of questionable character and cannot be trusted. Therefore, one finds that nearly all the regulations spell out precise activities which are prohibited. Since the number of ways that one could imagine to cheat the government are essentially without limit, so are the regulations. Therefore, it makes no sense to set out to study "the regulations". Rather, when one conceives of a plan to follow in order to accomplish Technology Transfer (TT), it makes sense only to try to determine whether there is a specific regulation forbidding such action or any part thereof. Also, keep in mind that (1) it is easier to apologize than to obtain permission; and (2) there are many ways to accomplish any given goal.

In most government agencies, there are many layers of authority that are expected to sign off before one can take any meaningful action. This has a direct effect on trying to accomplish TT, particularly since so many of the questions that arise are legal questions. Thus, within the Department of Veterans Affairs (VA), for example, any inquiry to District Counsel must be in writing and must go through regular channels. That generally means that your written inquiry must go through and be signed by the Director (and lesser officials) of the Medical Center in which you work. Consequently, there are not only time delays, misunderstandings, and a lack of interaction, but if District Counsel is involved, they will very likely refer your question (by letter or memo) to General Counsel (at Central Office in Washington, D.C.). This will involve further delays. But worst of all, the final written answer will be sent to the Medical Director, not to you! Therefore, there is no guarantee that you will ever get an answer at all.

In my own experience, I once tried simply calling District Counsel on the telephone for some kind of information to assist me in doing TT. I did not get an answer to my question, but I did receive (a few days later) a written reprimand from the Director of my own Medical Center for not going through the proper channels. Following that experience, I decided that for verbal questions relating to TT, I would simply call someone in the General Counsel's office in Washington. I discovered that once you find the right individual for the particular topic, their office is generally both cooperative and helpful. Of course, if you are seeking a legal ruling rather than a simple answer to a question, that must be in writing and must go through channels. But I believe you will get a faster and more reliable response if you write directly to General Counsel rather than to your District Counsel. Also, in writing the letter (to be signed by the Director of your Medical Center), be sure to include a paragraph asking that any questions regarding the letter be directed to you, giving your position and your business phone number. Further, I have found it invaluable to have an outside (i.e., non-government) attorney with whom I can discuss such questions. This can be accomplished by the formation of a TT Advisory Board (serving on a voluntary basis without charge), and finding a qualified attorney who will serve on your Board. Such an attorney should ideally be an experienced patent attorney with experience in (or knowledge of) Federal Laboratories, Federal Regulations, and TT, particularly negotiating license agreements.

In a memorandum dated September 17, 1996 to all VA employees, it has been stated that the entire VA healthcare system is currently undergoing a sweeping reorganization under which the District offices are being eliminated and field treatment facilities become part of new management and operational structures called Veterans Integrated Service Networks (VISNs). Just how this new reorganization will affect Technology Transfer is not yet clear, especially since VA headquarters in Washington has also been downsized and reorganized. Therefore, the comments in this section referring to District counsel may no longer be applicable. Much will depend on how Technology Transfer is to be treated within the new structures. Nevertheless, it should be borne in mind that any intermediate structures through which Technology Transfer matters must go means more possibilities for misunderstandings and delays.

After the passage of the Technology Transfer Act of 1986 (PL 99-502), which actually amends the Stevenson-Wydler Act of 1980 (PL 96-480), each Agency of the Federal Government was to issue guidelines for implementation. In so doing, the VA issued a lengthy document (VHS&RA Manual M-3, Part 1, Chapter 13 - see Appendix G) which illustrates some of the difficulties within the bureaucracy. For example, there is no mention of a Technology Transfer Officer (although one is required by the Stevenson-Wydler Act for Laboratories with more than 200 scientific engineering and technical employees). Rather, it is assumed that the only person on the technical staff involved in entering a Cooperative R&D Agreement with a company is the Principal Investigator (PI) on the project. All of the other people involved, and through whom everything must pass and be approved, are administrators! The result of such procedures is a document constructed by the PI, the Associate Chief of Staff for Research, and the Medical Director (or their delegates). In all probability, none of these has any experience in TT, let alone in negotiating and entering such agreements. Further, the PI (who may also have no experience in TT) may have little or no interest in spending his/her time in such an endeavor.

In reality, such activities are best carried out by a TT Officer (if there is one), but none of the official correspondence (usually written by that officer) goes through him/her, nor is there any mechanism for the TT Officer to receive any copies! (This situation stems from the underlying assumption that there is no such person.) Clearly, this system leaves many possibilities for delays, misunderstandings, omissions, oversights, and other undesirable consequences in dealing with industry. The fact that the rules and regulations are often written by people with little or no experience in TT does not help.

But perhaps the biggest lesson here is that, unless there is one person solely responsible for getting the job done on schedule (an absolute necessity in TT), it probably will not happen. In my opinion, this is the single biggest problem in a bureaucracy like the VA. Both the structure and the function of the organization are hierarchical, which means that one person is responsible for everything. (In reality, this means that no one is responsible.) When signatures on a piece of paper say more about a persons status than about who to call with questions, then quality and performance suffer. Therefore, if you are a PI or an inventor at a VA Medical Center where there is no one person in charge of TT, and you want your invention to be successfully commercialized, then you must act as if you personally have been assigned that responsibility (i.e. the responsibility of a product "champion"), or it will not happen. In other words, behave as though this document is written for you.

For the situation where there is a TT Officer, I have been following a somewhat different process for negotiating and entering CRADA's, which is given in Appendix H.

A suggestion that might be helpful in this environment is: If there is a choice, do not leave anything to chance. This means, for example, when there is a choice of using the phone or the mail or memos, use the phone! When there is a choice of sending something through local channels by memo or hand carrying it to get the necessary signatures, hand carry it! But this is touchy, since some people are either offended or threatened by being rushed (especially in the government). One must combine pragmatism with a little diplomacy. If you know that one person is like that, don't rush into that office for a signature, but leave it (personally) with the secretary. If things do not seem to happen in a timely manner, often the case in government, make discreet inquiries. But make sure that your job gets done as quickly and efficiently as you can make it happen. One of the best ways to do this is to know the key people, whether they be secretaries, confidants, assistants, or whatever, and establish a good working relationship with them. Get them to keep you informed as your paperwork passes through the system and ask whether you can help to speed things up.

An example of unnecessary (and sometimes unacceptable) delays by the bureaucracy is the procedure for the hiring of consultants. Not only must the consultant fill out all of the same application forms as a regular Federal employee, but the process goes through all the people in personnel involved in the hiring process. In dealing with TT issues and with industry in general, delays can be costly or downright disastrous. In a recent instance, I had a most enthusiastic and eager consultant come talk to us about transferring technology from Federal Laboratories. I was so impressed with his presentation that I discussed hiring him, and the group agreed that he had a unique and worthwhile contribution to make to our program. I attempted to get him working ASAP. (He was even willing to give us a surprisingly low hourly rate, far below his usual charge rate.) But about a month later, I found he had still not received a notice of his appointment as a consultant to our Lab. He called in my absence, and explained that he could no longer afford to reserve time for us without assurance of being paid, since he had a long list of waiting, paying customers. After checking around, I found that the appointment letter had a typo in it and was waiting on someones desk for correction. No one was willing to give us an estimated date of mailing, although we had been told two weeks before that he was officially approved for hiring.

This is an instance in which the problem might be resolved by using an account in the nonprofit foundation on your VA station if you have one. That is, while the administration is getting its act together, one might pay the consultant from such an account provided you have one into which that activity fits. (See Appendix I for the Federal Law which authorizes the establishment of such private, non-profit research corporations at VA Medical centers.)

One important point to bear in mind about the Bureaucracy is that for many Federal employees, the telephone is a course of last resort. That is, if there is a problem with anything that you have ordered, requested, or written a memo or letter about, the person spotting the problem will most likely not simply call you on the phone and talk with you. Instead, that person may write a memo (not necessarily to you!), or put it on the bottom of the pile, or simply return to the office that sent it. This can easily result in delays of days or weeks. This is why it is so important, particularly if you deal with industry, that you stay on top of every important thing you send out to make sure that what you have promised actually happens within the expected time frame. If it doesnt, it is both wise and courteous to let your counterpart in industry know what is happening.

Because of the numerous delays mentioned above in the processing of official documents, we have initiated here at Palo Alto a special system for the handling of TT documents such as a negotiated CRADA requiring official approval from General Counsel or requiring official signatures for execution. Such documents are first prepared here in the RR&D Center with the cover letter typed up in the very specific format and style required by our Medical Center Director. The cover letter is sent by fax to the Center Directors secretary, she then faxes necessary corrections, we make the corrections and assemble the package in the usual brown folder covered by a special Dark Green transparent folder, with both a green routing slip and pink Expedite slip attached. This package is then hand-carried to the Associate Chief of Staff (Research) for signature, then hand-carried to the secretary of the Chief of Staff and left for signatures, with instructions to call me when it is ready for mailing. The package is then picked up (yes, get up and go there to retrieve it) and mailed from here (i.e., the RR&D Center) so that we can retain copies and a record of when it is mailed. It is also highly advisable to use overnight mail if at all possible. This too will avoid unnecessary delays.

All of this may seem extreme, but the result has been a saving of one to three weeks of unnecessary delays while the document might otherwise sit on someones desk or in an in-basket waiting for action (e.g., correction of format or typos, affixing of a signature, or waiting for the internal mail system). Needless to say, this extent of expediting is to be reserved for very important, legal documents involving private companies. Over-use would of course render the special green cover meaningless, and the request for special handling would be ignored.