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What is National Drug Struggle Day?
The National Day for the Struggle for Medicines, celebrated on September 8 , is a date created to recognize the struggle of associations and NGOs around the world that came together for one cause: to ensure that people have access to medicines .
People who depend on drugs to survive and who often cannot access it at high cost, can resort to some initiatives that make drugs available free of charge or at a reduced price.
Within this campaign, those most benefited are those who need high-cost (exceptional) drugs, such as HIV- positive patients , for cancer or diabetes treatments .
In addition to programs such as Farmácia Popular and the very availability of some medicines made by SUS, the popularization of generics is also an important step to facilitate obtaining medicines at a lower cost.
Another important achievement in the fight for medicines was the patent break of large pharmaceutical laboratories.
As explained by the pharmacist Dr. Francielle Mathias, the laboratories that develop a new medicine have the patent of this product for a certain time, guaranteeing exclusivity of commercialization.
“This is because these products have a very high cost to be developed, and also to prove their effectiveness, safety and quality” he explains.
According to Dr., these drugs developed first are the reference drugs, and after the patent is broken, generics and the like can be manufactured from the formulation of the reference, which ends up cheapening the cost of the drug for the patient.
What are exceptional medications?
Exceptional drugs are expensive drugs prescribed for patients undergoing treatment for chronic or rare diseases. They are part of the Exceptional Medicines Program, created in 1993.
They are considered exceptional precisely because the majority of these drugs are of high unitary cost or, due to long periods of use (chronic diseases), they represent a high value.
These drugs also receive this classification when they are used to treat diseases that are not uncommon, but that affect a small number of the population.
Therefore, the production of these drugs is lower and ends up reflecting on the price and cost of treatment.
Patients who depend on these substances can count on the help of SUS to have access to them. They are usually discharged in outpatient health units.
However, due to the high value of the drugs, the release process becomes more rigorous.
The patient must present the Report for Request / Authorization for Exceptional Dispensing Medicines (LME) and a legible medical prescription with identification of the patient (two copies) with the name of the active ingredient (responsible substance) at the Health Unit where the service is received. pharmacological effect) and dosage.
In addition, for the drugs to be dispensed (delivered to the patient), it is necessary for the patient to present the National Health Card, consent form, exams and medical report with the other documents.
Among the main diseases in which high-cost drugs must be guaranteed by SUS are drugs for the treatment of hemodialysis, hepatitis C , chronic renal failure, hemophilia , multiple sclerosis, psoriasis , chemotherapies, precocious puberty and transplant patients.
What is RENAME and what is it for?
The RENAME , which stands for National Essential Medicines ratio , is the name given the list of drugs considered as a priority to meet the basic needs of the population.
It is from this tool that SUS pharmaceutical assistance programs must be based in order to meet the demands of patients.
This type of survey is a strategy devised by the World Health Organization (WHO), with the aim of promoting more rational and safer access to medicines.
Basically, RENAME works as a guide, so that the Ministry of Health can orient itself and understand which drugs should be offered, prescribed or dispensed by SUS services.
This list is available on the Ministry of Health’s website and must be updated and revised by Rename’s Technical and Multidisciplinary Update Commission (Comare).
What is the judicialization of health?
This is the name given to lawsuits whose purpose is to claim the right to medicines, surgeries, treatments and tests that are not offered by the Unified Health System (SUS).
Although there is a greater spread of the use of generic drugs and the free distribution of some drugs by SUS, the number of lawsuits to obtain access to medicines and treatments is still high.
In a nutshell, the judicialization of health would be the last alternative for patients who need medicines or treatments that were denied by SUS, either because of a budget issue or due to lack of foresight by RENAME (National Drug List), responsible for predicting the government supply, dispensation and prescription of medicines.
According to lawyer Melissa Kanda, a specialist in medical and health law, patients who cannot afford to pay for a lawyer under these conditions can go to the Public Defender’s Office to get an action to be entitled to the drug.
To do this, he must seek the defense of his state and gather all the necessary documentation.
Medicines not approved by Anvisa
Many patients face an obstacle to Anvisa’s bureaucratic processes for approving drugs that are already released in other countries and not in Brazil.
The rules used to guarantee the safety of the medicines registered in the country, unfortunately, in many cases end up becoming a stone in the way for patients who depend on these medicines to survive.
This product registration process does not have a stipulated time, as it varies according to the medication. There are three main parts to this registration process: pharmacotechnical analysis, effectiveness analysis and safety analysis.
Of these steps, there are still three processes that must be followed. The first one is the queue time that the product or medicine remains, the second is the analysis of the processes and, finally, the time that the company takes to comply with the requirements made by the agency.
According to Melissa Kanda, what the Supreme Court of Justice (STJ) determines is that drugs that have not yet been registered with Anvisa are not provided by SUS. “Even if the person goes to court, the request is likely to be denied,” says the lawyer.
By decision of the STJ, private health plans are also not obliged to supply medicines without registration.
There are, however, measures known as compassionate use or expanded access , which are exceptions to treatment. In compassionate use, the doctor who is aware of a new treatment indicates the patient so that he can receive these drugs without registration by Anvisa, provided by the laboratory he is developing.
In these cases, even without registration, the compassionate use of these drugs is made possible according to the RDC 38/2013 resolution , regulated by Anvisa itself, as the lawyer comments.
Expanded access, different from compassionate use, which is individual, is administered to groups of patients who use the same drug that is still in the development phase.
Distribution issues
In addition to the bureaucratic impasses in the fight for medicines, it is necessary to understand that there is still a distribution problem in the country.
After Anvisa’s approval, the Ministry of Health is responsible for forwarding the medications to the state and municipal spheres, where health units must be responsible for distribution to patients.
This process, which is often slow, ends up harming the treatment of people who need the drugs and are unable to obtain them by other means.
Generic drugs
Generic drugs are drugs with the same active ingredient, dosage and pharmaceutical form as the reference drug, considered the “original”. They are manufactured to have the same safety, quality and efficacy as the reference drugs.
Because it does not carry a commercial name and because it is not necessary to invest time and money in all clinical and non-clinical research processes during development, this type of medicine ends up showing a much lower value.
Thus, because they are as effective and reliable as the reference drugs, generics become a more accessible option for people who need to use them continuously, but who cannot afford to pay a high price.
According to pharmacist Dr. Francielle Mathias, generic drugs are an important milestone in the country in terms of improving patients’ access to the drug.
“These drugs expand the possibilities at the time of purchase, making it possible to purchase drugs with a lower cost in the vast majority of cases, in addition to ensuring quality, efficacy and safety”.
How does the Popular Pharmacy Program work?
Farmácia Popular is a program created to guarantee people’s access to medicines free of charge or at a price lower than the normal cost.
In order to obtain these drugs through the program, the patient must present a document with a photo (containing the CPF number) and a prescription within 180 days after the prescription at the accredited pharmacies .
This period, however, has some exceptions. In the case of contraceptive drugs, it is possible to present a prescription with a validity of up to 365 days, that is, 1 year.
The main drugs that are part of the program are for the treatment of diseases such as hypertension, asthma and diabetes, which can be removed free of charge.
Other medications, such as cholesterol drugs (dyslipidemia), Parkinson’s disease, osteoporosis , rhinitis , contraceptives and glaucoma are offered with a value of up to 90% discount.
The program, in addition to medicines, also allows access to geriatric diapers at a lower price.
Patients can buy through the program every 30 days for medicines for diabetes, asthma, rhinitis, hypertension, Parkinson’s and osteoporosis, and in the case of glaucoma, with an interval of 25 days.
Geriatric diapers can be purchased every 10 days, and 40 units can be removed. To consult which drugs are available through the program, it is possible to access the list made available by the Ministry of Health .
Other ways to save on medicines
All people, whether or not they depend on medicines to survive, can have access to medicines at a lower price.
Some tools make this comparison possible and help people save money when it comes to health.
The consultation remedies , for example, is a platform that helps patients find the drugs at the best price in online pharmacies throughout Brazil, also offering complete information on medicinal products. In addition, it is also possible to check the prices of the Popular Pharmacy program at accredited pharmacies.
The National Day of Struggle for Medicines aims to remember the struggle of people who depend on medicines to survive and who often cannot access them easily due to the cost or unavailability in public health systems.
In addition, the date is important to reinforce the need for programs that help in this process, as health is a fundamental right of people and must be guaranteed. Thanks for reading!
