We've all heard bullish predictions about a biotech revolution in the 21st century to rival the commercial success of the IT revolution of the late 20th century. But we know how that ended, and it wasn't pretty. Make no mistake: genomics and related biotech advances have the potential to transform the way medicine is practiced. But they'll need help. Without the right regulatory environment and a concerted effort to work with skeptics and fear-mongers, biotech will fall short of its potential.
Two recent speeches by Britain's Prime Minister Tony Blair have highlighted governmental concerns over whether the ambitious expectations for the industry will be met. Creating wealth from new medical biotechnologies - such as human genetics, stem cells, cloning, gene therapy and animal-to-human organ transplantation - is a priority for the U.K. government, its partners in Europe and North America, and the pharmaceutical and biotech industries themselves. So what can be done to make commercialization a success?
Biotech's advocates can begin by learning valuable lessons from other industries. Nuclear physics, for example, generated analogous concerns, and despite the promise of cheap and unlimited energy, stakeholder worries over this energy source won the day. More recently, the public backlash against genetically modified food has had a similarly profound influence on the agrochemical industry, derailing ambitious plans in this area. However, GM food is merely the tip of the biotechnology-ethics iceberg - medical technologies have huge moral and ethical implications, not just for us but for future generations. How then can the business avoid the risk of a similar controversy derailing commercialization of new medical technologies?
Mr. Blair correctly highlighted the difficulty of the task. Last month, the U.K. government addressed half the equation by launching its strategy for promoting Britain as a base for biotech research. But equally important, the industry needs a license to operate from the general public. To accomplish this, governments and industry need to bear in mind four guiding principles.
First, include the broader stakeholders. Initial GM-seed products offered compelling financial benefits to customers (farmers) but not to consumers, and suffered the consequences. Similarly, animal-organ transplants for terminally ill patients are life-saving. Yet regulators and society balk; the patient benefit is seen as being outweighed by the risk of transferring harmful animal viruses to the human population. To avoid the GM pitfall, all those involved in medical technologies - from government to individual companies - and the increasingly powerful non governmental organizations (NGOs), must build and sustain a dialogue and share decision-making.
One route is to adopt some of the experimental governance models that are emerging in other industries to encourage buy-in from outside stakeholders. The Sustainable Forestry Board, a board of 15 directors comprised of five NGOs, five CEOs from industry and five "others," now sets standards for sustainable practices within the American forestry industry.
But dialogue, even once opened, is not easy. Stakeholder views are driven as much by perception and emotion as rationale. Consider the two technologies of food preservation by irradiation, and mobile phones. Both technologies have benefits; both have been subject to media scares about associated health risks. However, while few European countries have legalized irradiated foods, over 70% of EU citizens choose to have a mobile phone. Perceptions, rather than expert opinion, are driving the current U.K. debate over safety of the measles-mumps-rubella vaccine. Most medical experts are skeptical of the vaccine's alleged link to autism, but the dangers from infant measles are clear. Even so, local outbreaks of measles are increasing in the U.K. as fewer parents agree to MMR (measles, mumps and rubella) vaccinations.
Second, governments must work closely with industry and NGOs - early on in commercial development - to articulate the societal challenges that biotech can help solve and establish broadly agreed perceptions of cost-benefit and risk-reward. Privacy concerns about genetic population screening is one issue that would benefit from this kind of cooperation.
To some, increased and earlier government or NGO involvement may smack of unnecessary intervention. But if government does not take the lead, it risks being seen as unresponsive. In addition, a failure by government to address public perceptions could force their hand at a later date, resulting in regulatory decisions that are less than optimal.
Signs of cooperation are emerging. In 1998 the Single Nucleotide Polymorphism Consortium began to advance medicine through publicly providing a map of human genetic variations. The consortium was backed by corporate members, the U.S. National Institute of Health and was coordinated by the Wellcome Trust. Such collective activity must extend into the commercial arena.
Third, industry must balance the need to compete through innovative use of technology with the need to collaborate in an unprecedented manner in areas that are initially noncompetitive, such as product names. For example, the "genetically modified" tag helped conjure the "Frankenfood" connotations that so scared consumers with GM food. Now the medical industry is in danger of making a similar mistake. Is the best name for a test that optimizes medicine choice to the individual really "pharmacogenetic test" or "theragnostic"? A better label, say, "best-medicine test" - would convey the benefits, instead of scaring consumers with more science they don't understand.
Finally, companies must not overcommit to a predicted future. They need to recognize that new technologies are often profoundly disruptive. Disruption breeds uncertainty, and who knows what animal cloning will be used for 10 or 20 years from now - for food, or organ transplants or drugs? In those areas that remain competitive, companies will need to manage the uncertainties that medical technologies bring. Shell's use of scenario planning, for example, has helped the Anglo-Dutch firm to rise steadily in the ranking of world oil majors over several decades.
Companies using medical biotechnology will need to organize against the major extremes of future uncertainty, with one current extreme being the degree of public acceptance. As illustration, one might expect companies developing pharmacogenetic tests to follow where possible the recent example of DakoCytomation's Herceptest. Although based on underlying genetics, Herceptest actually uses a protein test to judge the suitability of Herceptin therapy for breast cancer. In this way the potential emotive objections surrounding genetic testing are avoided.
Did Sciona consider public acceptance sufficiently when last year it became the first British company to sell genetic tests directly to the public? Perhaps not. After a campaign led by the pressure Group Genewatch, Sciona recently made a commercial decision to stop direct sales, using doctors and professional dieticians instead.
GM foods showed us that the failure of key stakeholders to accept new technology can remove a sector's license to operate, swiftly and drastically affecting even blue-chip firms. Five of the top seven companies involved in commercializing GM-Food technology in 1998 have since divested their agrochemical and seed interests or merged. The possibility of similar scenarios with medical biotechnology should not be underestimated. However, with the right framework in place, although the road to commercialization may still be rocky, we will be far more likely to deliver the tremendous potential benefits of these technologies - drastically improved health care.
