AsianScientist (Jun. 27, 2012) – Many of us may recall our childhood trips to the doctor’s clinic to receive a routine immunization on the arm. These visits – however unpleasant – were important: experts estimate these injections help to prevent two to three million childhood deaths each year.
But while vaccines are still the least expensive way of controlling the spread of infectious diseases, with limited distribution channels and the lack of a lucrative market in the developing world, it is more the rule than the exception there for children to die of common childhood conditions such as measles.
According to Dr. Margaret Chan, Director-General of the World Health Organization (WHO), at the 2011 Pacific Health Summit, “a vaccine that is too expensive for the developing world is worse than no vaccine at all.”
Indeed, pharmaceutical companies have heeded the call to make vaccines available to those who cannot afford them. In June last year, leading drug companies announced dramatic slashes in vaccine prices for the developing world, including a 95 percent price cut on the new rotavirus vaccine that can prevent diarrheal deaths.
As with most gifts and concessions, the process is ultimately a non-sustainable one, as the recipient community may still be unable to provide for itself. So who then, besides the drug companies, can a developing country turn to when a vaccine is desperately needed there?
Enter the World Health Organization (WHO) Technology Transfer Initiative (TTI), whose mandate is to promote increased access to health products through the transfer of technology and local production.
Dr. Martin Friede, Program Leader for the Technology Transfer Initiative (TTI), was in Singapore recently as part of a fact-finding delegation to learn more about Singapore’s biomanufacturing model and to find common areas for collaboration.
Friede, who joined the WHO in 2003, received a PhD in biochemistry from the University of Cape Town, South Africa, and is the expert on all things vaccine. Prior to the WHO, he was a Vice President of Development at California-based vaccine biotech, Apovia Inc, and senior scientist at GlaxoSmithKline, where he led a team on vaccine formulation research.
Technology transfer = When + Which + Where + How
Friede describes technology transfer as a four-part series: the team first identifies whether a certain type of technology would improve health (when), before identifying the product (which), and then the recipient and donor (where). Then comes the hardest part: how best to conduct the technology transfer from a technology donor to its destination (how).
“We identified that frequently the best way is to find a non-profit somewhere, undertake a certain amount of development, and then from there give it to multiple centers. This technology transfer hub is wherever possible our preferred model,” he explained.
When a disease burden is identified – and this may vary widely from cardiovascular disease to hearing problems, the team then looks for an effective treatment to the disease. Next, the team looks for barriers to access such as cost, intellectual property situation, and feasibility.
And in most cases, the barrier to access is a policy barrier, Friede says.
“Quite often, the absence of access is policy. The local government has not adopted a policy to using that intervention, either because they are not aware of it, or they have other priorities, or it is just not on their radar screen. And if policy is the barrier, then we do not try to do technology transfer, we try to get other teams to assist the government to develop a policy,” he says.
If the technology is locked up as intellectual property (IP), Friede’s team will look out for when the patents expire, or countries where the product has not been patented in, or negotiate with the patent owners.
In other instances, feasibility may instead be the issue. A device may work very well in a hospital in Singapore, he explains, but not in a hospital in Sudan, because the electricity is failing, or the machines just aren’t maintained properly.
For example, in the event of an influenza pandemic, access to a vaccine may be hindered by absence of local capacity as well as limited global capacity. During a real emergency, governments from countries with local production may choose to store the vaccine as part of its national security policy, instead of sending it to other countries that are unable to manufacture their own.
“In the event of a pandemic, for a vaccine being produced in country A, you can be fairly sure that the government won’t allow it to go out of country A before everybody in country A has been vaccinated,” he says.
One solution for country B, C, and D, Friede says, is to produce their own vaccine, and to draw up a plan to scale up production during a pandemic.
But help does not come knocking to just any developing country. According to Friede, because the WHO is an international inter-governmental organization, member states must first request for help from the WHO team. The team then considers possible actions, inspecting the IP situation to find a licensing structure for that country, and ensuring that the project makes sense from both a health and economic perspective.
Even then, having the legal freedom to make the product isn’t enough, Friede says. Equally critical is the technological know-how and infrastructure to manufacture the product.
“If the manufacturer does not know how to make it, we need to find somewhere or someone to teach the manufacturer how to make it. Ideally we want to go to a country that already has a factory, that has most of the equipment already in place, so that the additional costs are already minimal,” he says.
Technology transfer is a game of push and pull, he explains. To entice local manufacturers to make the drug, the team tries to reduce the upfront costs and financial risks that these companies would have to undertake – this is achieved by various mechanisms such as providing seed funding, providing the know-how, training etc. Pull mechanisms include providing data on the disease burden and markets, but for some products such as vaccines may also include promoting the establishment of market commitments.
After sorting out the IP and manufacturing channels, the team then puts into place a value proposition.
“Because if you cannot, and if you don’t have a business plan, you don’t have a business,” says Friede a matter-of-factly, “and we cannot be promoting these ‘sinks’ where money just keeps getting sunk into them.”
But not all vaccines and health products need to be profitable, with the pandemic influenza vaccine a good example of an exception to the rule.
“In the case of pandemic influenza, this is a national security resource, so some countries have opted to view this as an exception that they will maintain that capacity in case there is a pandemic. That is a national prerogative to decide we are going to take that risk and make that investment,” he says.