Table 2. Obstacles to the adoption of... | Emerald Publishing

Table 2.

Obstacles to the adoption of personalized medicine – characteristics of the health-care system

Obstacles – health-care system characteristics	Description
Government plan	MP is not a government project; there is no plan or strategy
HTA	The HTA methods are unsuitable for PM HTA is not adequate for oncology and rare diseases because it needs standardized outcomes; it does not have the sufficient quantity and does not have a clear outcome. The “n” is small, and the patients are treated at referral centers
Epidemiological studies	The epidemiological studies are insufficient There must be epidemiological studies (and there must be individual mapping), even though populational studies are not obstacles in the short term
Technology assessment	Technology assessment in large-scale use is an obstacle for SUS and supplementary health There is no panel comparing the different technologies HTA is a recent area in Brazil, and its lack of activity is a barrier
Human resources	The human resources are insufficient and are not prepared for PM In October 2017, only 260 geneticists were registered with the Federal Council of Medicine, concentrated in the southeastern states
Infrastructure	The infrastructure is not prepared for PM. Many of the new medications have dispensing forms that require different physical structures than the ones of current medications
Cost	Technologies are expensive, and the cost of innovation is increasing: the cost grows more than the benefits, compared to preventive methods
Regulation	The way through which Anvisa monitors the new technologies is different from the way it controlled the previous ones. Technology, production process and quality are different for immunobiological products and gene therapies The medications must be released by Anvisa; there are not many drugs for rare diseases, and there are only international studies about them Anvisa and the National Council for Ethics in Research (CONEP) did not recognize studies with few patients as valid. They would have to be multicenter. The degree of certainty is very small, and there are difficulties in obtaining clearer evidence
Clinical and genomic information	Clinical and genomic information must be on an integrated basis with transparency and confidentiality A pillar of PM is the access to clinical and genetic information of the population, “we need information from Brazilians, as there are ethnic issues, many different Human Development Indexes, and several different types of Brazil”

Obstacles – health-care system characteristics	Description
Government plan	MP is not a government project; there is no plan or strategy
HTA	The HTA methods are unsuitable for PMHTA is not adequate for oncology and rare diseases because it needs standardized outcomes; it does not have the sufficient quantity and does not have a clear outcome. The “n” is small, and the patients are treated at referral centers
Epidemiological studies	The epidemiological studies are insufficientThere must be epidemiological studies (and there must be individual mapping), even though populational studies are not obstacles in the short term
Technology assessment	Technology assessment in large-scale use is an obstacle for SUS and supplementary healthThere is no panel comparing the different technologiesHTA is a recent area in Brazil, and its lack of activity is a barrier
Human resources	The human resources are insufficient and are not prepared for PMIn October 2017, only 260 geneticists were registered with the Federal Council of Medicine, concentrated in the southeastern states
Infrastructure	The infrastructure is not prepared for PM. Many of the new medications have dispensing forms that require different physical structures than the ones of current medications
Cost	Technologies are expensive, and the cost of innovation is increasing: the cost grows more than the benefits, compared to preventive methods
Regulation	The way through which Anvisa monitors the new technologies is different from the way it controlled the previous ones. Technology, production process and quality are different for immunobiological products and gene therapiesThe medications must be released by Anvisa; there are not many drugs for rare diseases, and there are only international studies about themAnvisa and the National Council for Ethics in Research (CONEP) did not recognize studies with few patients as valid. They would have to be multicenter. The degree of certainty is very small, and there are difficulties in obtaining clearer evidence
Clinical and genomic information	Clinical and genomic information must be on an integrated basis with transparency and confidentialityA pillar of PM is the access to clinical and genetic information of the population, “we need information from Brazilians, as there are ethnic issues, many different Human Development Indexes, and several different types of Brazil”