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by P. H. Campbell

Created on: March 26, 2008

Inasmuch as the profit motive in the medical field raises the hackles of those who believe it should be motivated purely by altruism - especially in times of emergency as would be the case in an epidemic - a patent protects not only the intellectual rights of a product, but the investment in creating that product or process. Vaccinations are not developed for free. As is evidenced by the recent cessation of two promising AIDS vaccine trials due to an increased risk of acquiring the disease if 'vaccinated', there is a lengthy and expensive process needed to get a product from the idea stage to the market. Not all products (medications, vaccines, etc.) intended for human use make it through this process. The time, effort and investment in that line is wasted, but something can be gleaned from that waste in the form of proprietary processes that are, in fact, unique and patentable. Drug industry statistics report it takes anywhere from three to ten years to get a drug from idea to market. Three to ten years during which that drug, medication, vaccine, etc. is not earning an income through sales or use.

Nor are these medicines developed in isolation. The processes for creating a Bird Flu vaccine for example are basically the same as for producing any vaccine involving a viral vector - the regular flu, viral meningitis, Ebola, etc. Many rival companies are attempting to develop vaccines and medications for similar problems, creating a rivalry which, once the medicine IS taken to market, may turn out to be less effective than a competitor's similar drug. Further, once a medication is released for public use, other effects not seen or documented in the trial phase can result in a recall, limiting sales and earnings. Patents, either for processes or for the drugs themselves, ensure that a medication can be made at least somewhat profitable even if the drug itself is never approved for public use.

But to just give up the patents on developing a vaccine, even one as needed as one in a pandemic (such as the much-touted but yet to materialize H5N1 'Bird Flu') means a company gives up all rights to recouping any and all investment made in creating that process. While few drug companies are in danger of insolvency, patents ensure that a drug company retains the RIGHT to license that process. It doesn't necessarily mean they're going to withhold it until their price is met. In fact, doing so could cause a huge reversal in the company's fortunes through bad publicity or the possibility of their company being nationalized or the patent seized due to the urgency of the situation.

Many people believe that drug companies would rather make a profit than actually help the people who use their products. Hollywood reinforces these misconceptions with conspiracy theory kinds of movies portraying drug manufacturers as heartless behemoths only interested in making a buck at the expense of an ignorant public. Some past actions on the part of some drug companies who have had their released products removed from the market due to discrepancies in the safety of the product between the trial and the release tend to reinforce these misconceptions. But while a drug company is in the business of making money, inasmuch as it needs to keep the shareholders happy, the fact is any negative publicity impacts the bottom line.

From a more practical point of view, what happens if a drug company withholds its efficient, vaccine-making process in the event of a pandemic in order to make more money? People die. If people die, who buys the drugs? Businesses are often accused of being short-sighted in profit projections, but removing thousands or millions of potential customers from the market is hardly the way to maintain company solvency, let alone earn profits. Patents only ensure that once the emergency is over, the company will be reasonably recompensed for its efforts or methods.

A patent also allows the company to quickly license its processes to be used by other companies, thus increasing the rate of production. Giving up the patents means that all other drug companies - the competition - will be able to use these processes without compensation for the time, effort and cost of developing them in the first place. Further, releasing the patents means a government entity would be in charge of assigning who does what, creating a bureaucracy outside of the normal business practice channels, which could easily result in delays and deaths.

Businesses are in the business to make money. This much is evident. But businesses are also in the business of STAYING in business. Giving up patents for processes they developed, and knowing this will happen, is a huge disincentive for a company to create those processes in the first place. The profit motive makes companies try to minimizing costs in creating the products they have a chance to develop into a money-making product. The profit motive also ensures that patentable processes will help defray the costs in developing new drugs and vaccines, spurring innovation and efficiency. Processes in creating drugs are trade secrets and part of the investment in creating these drugs.

But drug companies knowing they have no chance to reap any profits means fewer resources will be devoted to the effort of developing the patentable, efficient, proprietary processes necessary to make a bigger profit, resulting in less product being made available. Innovation will be stifled and less efficient, but well known, processes to develop vaccines will be used instead. In the end, vaccines desperately needed may not be available because no one developed a more efficient method of doing it.

Drug companies need a to make profits. They do this, in part, by patenting and licensing their production processes to help defray the huge costs of getting that product to market. They are interested in selling their product, not killing people. Withholding processes that can increase the efficiency of vaccine production in the face of a global pandemic is a huge PR black-eye for any drug company. Governments would intervene and the company may not survive the crisis.

They understand the need to move fast in an emergency and leaving the normal business channels intact means fewer hassles in ramping up production since licenses, permissions, fees and costs can be negotiated quicker through established business practices and means. It maintains solvency for companies that may otherwise be forced out of business by heavy-handed government practices and allows them to be solvent after the emergency to continue to produce the drugs upon which we've come to depend. It strictly limits the licenses involved in allowing other companies to use previously patented methods to develop vaccines for their own gain and profit. It keeps everyone honest and doesn't give an unfair advantage to other, less innovative companies by giving them a windfall in learning secret, more efficient processes upon which they could potentially reap an undeserved profit once the emergency has passed.

If any legislation is needed, it is to put in place an efficient means of quickly determining how licenses for vaccine-making process patents will be assigned, used and paid for in the event of an emergency so that multiple companies can begin churning out vaccines as quickly as possible. If the plan is set in advance, letting the companies know in advance of who will do what, who gets paid what and what happens after the emergency has passed, then at least the emergency can be met without by existing businesses and organizations without the need to be overseen by wasteful government bureaucracies or threatening the post-emergency solvency of drug companies who actually developed the life-saving processes in the first place.

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