04/04/2013 02:24 pm ET | Updated Jun 04, 2013

A Developing World Strategy for Personalized Medicines

In 1990, the U.S. National Institutes of Health began an effort to map the human genome. This effort known as the Human Genome Project is considered the genesis of personalized medicine and was successfully completed in 2003. Although the Project was funded by the U.S. government and carried forth by the National Institutes of Health, it was supported internationally in cooperation with the United Kingdom, Japan, Spain and Germany.

Propelled by improvements in technology, software and computing power, personalized medicine is quickly moving from potential to reality. Personalized medicine introduces treatment protocols that indicate the risk of disease on a genetic level before symptoms appear. The ability to identify, track and treat conditions before diseases reach advance stages of development improve the survival rate and quality of life for patients as well as increase the efficiency and affordability of health systems.

Because of its technology intensive platform, personalized medicine is seen as solely benefiting the populations of developed economies. Developing economies and health systems won't have or won't allocate the resources for adopting personalized medicines protocols. But for developing economies, the economics will play a crucial role in how it develops. Treatment protocols for smaller more specific populations might increase initial costs, but the targeted strategy should be more effective, more quickly and with fewer side effects. The benefit in a cost-benefit calculation would substantially increase -- as would the efficacy of the treatment.

Challenges Ahead

Generally in developing economies, half or more of the health services delivered will come from the private sector and the vast majority of the payment will be out-of-pocket. Although progress is being made in microinsurance offerings, it is unrealistic to expect more than a fraction of the population to be able to afford the battery of tests that identify a person's genetic disposition. Even in the richer nations, payer organizations are reluctant to pay for genetic tests because the numbers of tests are increasing with over 2,000 (Physician liability: the next big thing for personalized medicine?," Gary E Marchang, Doug E Campos-Outcal, Rachel A Lindor, Personalized medicin. 2011; 8(4): 457-467) currently identified and there is not a lot of longitudinal data to support or identify which tests are effective and capture long-term savings. Capturing long-term savings also means long-term tracking of the individual.

All health systems face the challenges of containing costs while increasing the access to quality health services. For the foreseeable future, any integration of personalised medicines into a developing country's health system will have to be government mandated, enforced and heavily subsidies/paid for. The calculations of cost benefit, efficacy and cost avoidance will challenge the government officials in developing countries health systems because for the time being, the government will be the only one able to consider bringing forth personalized medicine. The advancement of personalized medicines and their adoption within health systems will force the re-evaluation of policy, education, ethics, laws and the use of clinical information delivering health services.

Second Verse, Same as the First

The divide between the North and the South/rich and poor nations has existed since colonial times. In health care, specifically access to medicines, the clash of perspectives is already being played out in the fight between the supporters of intellectual property and pharmaceutical patents versus proponents of low-cost access to medicines. The point of contention is that providing low cost access to patented medicines has come at the expense of patent infringement -- ignoring the patent. The controversy is not close to a resolution, with both sides firmly entrenched in their positions. The difference and perhaps a saving grace in the case of personalized medicine is that in the nascent stages of personalised medicine, much of the advancement is predicated on computing power, data processing and studies targeting smaller populations.

Public sector officials and ministries in the developing world must carefully consider the public's rights, responsibilities and access to the advancements that they have funded or supported and how that translating to an access strategy. Analogous to rent control and affordable housing programs the blend of equitable access while ensuring market value will be paramount.

A roadmap for developing countries to benefit and contribute to the advancement of personalised medicines would include the following:

• Pooling South -- South research capabilities. Bi-lateral and multi-lateral agreements between ministries of health as well as research and academic institutions.
• Coordinating research efforts and harmonising regulatory agencies agendas and priorities
• Using the joint research efforts to provide the backbone for interoperable systems between ministries, countries and regions.
• Educating and clearly articulating why the investment in personalised medicines, versus directing resources toward more immediate and wide spread disease and health challenges such as HIV/AIDS, malaria, etc