In order to better understand and evaluate the impact of type 1 diabetes treatment in people's life, we developed a research with 12 questions to obtain basic information about the knowledge of patients about diabetes. This survey was published on Facebook pages and more than 200 responses were obtained. The information has been compiled and is presented below.
Age
The first question is about the age of people who answer the survey. We can observe that the most part have about 21 to 30 years.
Diabetes type
The means of survey dissemination were mostly directed to people with type 1 diabetes, showing consistency with the answers obtained in the second question. Insulin use is in agreement with the percentage of type 1 diabetics who answered the survey.
Accessibility to the treatment
The graph below shows that only 15% of people with diabetes receive government aid, even the government taking responsibility for distributing the drugs to the patients. About 20% of diabetics spend over $ 150 on treatment, showing the importance of developing cheaper treatments. To corroborate the high costs of medicines and other treatment materials, 92.6% of participants consider treatment expensive.
According to the information obtaine above and the graph below, it is possible to confirm the government's real deficiency in providing the medicines and materials necessary for patients free of cost, since 67% of the participants consider difficult to obtain them.
Insulin therapy
A great part of the patients use insulin about 3 to 5 times per day, which is a considerable number of applications. The most part of the answers show that people don't known about the number of insulin applications that they use, indicating the banalization of the treatment and the need of more information about.
The result below is very interesting for us. About 80% of the answers show that the usual treatment is invasive for patients and 67% answer that the treatment affects their routine. This indicate the importance of the research and development of new treatments for diabetics, that will improve the quality of their lives.
An interesting conclusion of the graph below can be considered, showing that most people are willing to use genetically modified medicines. In this way, our technology could be well accepted by community of diabetic people.
Conclusions
Public data shows that type 1 diabetes is an emerging public health problem in Brazil. With this survey we could reach people and hear their opinion about the current treatment and how they are supported by the public healthcare in our country. We were able to see that the government doesn't always fulfill all the pacient's needs and there is a lack of information about the disease, how treat it correctly and live well. We decided to go further in this subject: we wanted people to know the disease and how to handle it correctly to have a better life. We noticed that when people are diagnosed, they don't have much information about how their life is going to change completely but still can be a normal and healthy life, mainly for children and their parents. In order to help these people, we put our efforts in collecting and spreading informations about it. To see how our team did that, please see our Integrated Human Practices page.
type 1 diabetes around the world
To get information about the distribution and treatment of type 1 diabetes in other countries and cultures, we asked for the collaboration of other teams to raise data on this. With this we obtained:
In Estonia:
70,000 cases of diabetes, being that 7,000 are related to type 1 diabetes. The frequency of cases is around 10 to 11 cases per 100,000 inhabitants. Most treatments (fast acting and intermediate insulin), lancets and glucose meter used to control blood glucose and monitor the efficiency of treatment are paid at up to 90% of their value by health insurance plan.
In Australia:
About 3.61 million australians have diabetes or pre-diabetes, 10-15% of which are for type 1 diabetes. It is the sixth leading cause of death in Australia. About 6.5 billion dollars a year are spent on diabetes treatments. There is a free app to follow meals, publications and news on the subject.
In the United Kingdom:
There are about 3.8 million people with diabetes, of whom 370,000 are related to type 1 diabetes. It spends about 10 billion pounds is spent a year on treating diabetes. Insulin is provided by the NHS member body, the Oxfordshire Clinical Commissioning Group, the organization responsible for purchasing and supervising health services for more than 700,000 people living in Oxfordshire through a government money.
We would like to thanks the teams Tartu TUIT (Estonia), Sydney Australia and Oxford (UK) for sharing these data with us.
A collaboration with the Manchester Team provided us an opportunity to learn about the laws in our country regarding the research, use and commercialization of GMOs. Manchester Team invited teams from all over the world to look at GMO laws and regulation in their countries related to products containing genetically modified organisms.
This legislation may be established by governmental institutions as is the case in Canada or outside institutions specializing in GMOs where government institutions only apply and enforce laws, as is the case in Brazil and the USA. However, there are countries that do not have a clear control of this, like Chile. These regulations impact the commercialization of products, both in foods and health (biopharmaceutics). In foods, most countries require the labeling of a product with a genetically modified product, as is the case in Brazil and Australia, whereas Canada requires this labeling only if there is a risk to the consumer. For registration and trade of medicines, it is necessary to describe all procedures and risk studies, which will be analyzed by the FDA or Anvisa, in the case of the USA and Brazil, respectively. Being recent, the use of GMOs is still new to the population and governments, which may lead to legal prohibitions due to lack of knowledge.
Here, we present the data we have collected about the questions proposed by Manchester Team, regarding the GMO legislation in Brazil.
1. What institutional body enforces the laws regarding the use of GMMs?
In Brazil, the Biosafety Law (Law 11105/05) sets the safety rules and fiscalization of GMMs and its derivatives in the national territory. The National Technical Committee of Biosafety (CTNBio) is responsible for enforcing the laws and setting the rules for the construction, experimentation, cultivation, manipulation, transport, commercialization, consumption, release and discarding of GMMs and its derivatives.
2. Who regulates the use of GMMs on a case-by-case basis?
The Brazilian Health Regulatory Agency (Anvisa) approves and inspects the use of GMMs and its derivatives in any products for human use (e.g., pharmaceuticals, biopharmaceuticals, cosmetics and food). The Ministry of Agriculture, Animal Husbandry and Supply (MAPA) is responsible for regulating the use of modified seeds and plants. All GMMs must be approved for release by CTNBio.
3. What legal requirements do I have to fulfil in order to be able to use GMMs in my business?
In order to use a GMM in your business, one needs to fulfill numerous requirements. The development of any GMM must be monitored by the CTNBio and the regulatory agencies. If your company is going to start working with GMM, the first step is getting the Certified of Biosafety by CTNBio and create an internal committee of biosafety. Then, you need the approval by the regulatory agency (e.g. Anvisa for human purposes and the MAPA for agriculture purposes). You are going to need to fulfill a lot of requirements in order to get the registry and the permission to develop your research in your lab.
For agriculture purposes, once you have finished your research inside the lab, the CTNBio will evaluate it and emit a position paper that will allow you to do a planned and controlled release. To do that, you are going to need to fulfill the requirements of the Normative Resolution n. 6 of November 6th, 2008.
For medical purposes, once you finished your research inside the lab, you are going to need to ask Anvisa for a registry of biological medication and you are going to need to fulfill all of the requirements stared in the Resolution n. 55 of December 16th, 2010.
Once your product is registered and approved by CTNBio and MAPA or Anvisa, you will be able to release and/or commercialize it.
4. As an employer who exposes their workers to biological agents, what safety measures am I obliged to adopt?
There are no rules regarding specifically the exposure to biological agents; the employers must monitor the exposure levels under the same rules for other substances (Act 3214/1978).
5. As a consumer, how do I know if a product I want to buy contains GMOs?
Currently, if the product is made of a GMMs plant/seed or if the final product contains any traces of a GMM used as an ingredient, the package must have a symbol “T” of transgenic (figure below) on its package and the words “This product contains [name of the organism] transgenic.” However, the Congress and the Senate are currently voting on a project that modifies this law to remove the “T” symbol and leave the words “This product contains [name of the organism] transgenic” only if 1% or more of the final product has been genetically modified.
6. What are the most important documents related to GMMs?
Law 11105/2005 - Biosafety Law: creates the National Technical Committee of Biosafety (CTNBio)
Law 11460/2007 on planting GMMs in unities of conservation
Act 5591/2005 regulates the Biosafety Law
Normative Resolution 2, November 27th, 2006 on the classification of GMMs’ risks and the biosafety levels
Normative Resolution 5, March 12th, 2008 on the commercial release of GMMs and its derivatives
RDC 55/2010 on the registry of biological products (e. g. biopharmaceuticals)
Discussion
Our project is to develop a new treatment for type 1 diabetes using a genetically engineered probiotic bacteria, which means that to this project became a real product someday, it would have to go under several safety assessments and approved to be used in humans.
Over this year, as we worked in our project, we were always worried about the legal requirements for a GMO like ours become a real product and how biosafety laws affect and guide the development of new GMOs. This work was very useful to us to look for and understand the laws of our country, the steps that we would have to take if we wanted our project to became a product. Knowing the informations that we've presented here is important not only for us while developing our project this year, but it is also important of us as biotechnologies students and professionals.
This work was not only useful to understand the complexity of Brazilian laws, but also to identify some aspects in the legislation that could be improved. In general, doing research and using GMOs in our country is not a trivial work. Maybe some deep reflections and revisions in the legislation could make the research and use of GMOs less challenging, easier and faster whereas keeping in mind the citizens' safety.
Another thing that we could notice is that the information about GMOs legislation in Brazil is very diffuse, this means that finding it is a very time-consuming task. An initiative from the government in creating a page where people could easily find all the information would be very useful. We hope this work could help future Brazilian teams and people working with GMOs to have a guideline and an easy way to find the information about the laws and institutions that guides the work with GMOs.
