Misinformation about generic drugs can lead us to make the wrong decisions when it comes to using them. The origin, quality and therefore the effectiveness and safety of these medications are commonly questioned. Prices depend on many factors and vary to the same extent.
The Colombia National Food and Drug Surveillance Institute INVIMA administration has been working on the dissemination of information about generic medicines and the demystification of false beliefs, and makes available all the necessary information:
WHAT ARE GENERIC DRUGS?
Generic drugs are pharmaceutical products that are marketed, without a license from the innovative company, after patents or other exclusive rights expire. Generics have the same active ingredients, concentrations, dosage forms, uses, routes of administration, doses in indications as brand name drugs.
DO THEY COST LESS BECAUSE THEY ARE INFERIOR TO THE BRAND NAME DRUG?
Generics cost much less than brand name drugs, in some cases 60 to 85% less, but they are equally effective and reliable. Generics cost less because they do not include research and development costs or patent costs. Additionally, their manufacturers spend less on advertising and promotion.
QUALITY, EFFECTIVENESS AND SAFETY OF GENERIC DRUGS | ARE THEY AS EFFECTIVE AS BRAND NAME DRUGS?
INVIMA tracks products sold in Colombia and has not found significant differences between brand name and generic drugs. These have the same active ingredient, the same mode of action and the same amounts as brand name drugs; therefore, the therapeutic effect is the same.
INVIMA requires that bioequivalence studies be presented in some medicines with special characteristics, to ensure that the same amount of active ingredient is delivered at the same time as the brand name product. In addition, verify that all generics comply with good manufacturing practices before granting a sanitary registration. This includes the use of quality raw materials, appropriate manufacturing facilities and adequate and sufficient tests to demonstrate product quality.
In many cases, companies that manufacture brand name drugs also manufacture generics, under the same quality parameters.
INVIMA requires that all medications meet the safety criteria. Since generics have the same active ingredients and the same mechanism of action as brand name drugs, it has the same safety profile. This entity is the only one in charge of guaranteeing the medicines in our country.
INVIMA expands information on the process of quality assessment and marketing of all medicines, to clarify that a comparison of this process between brand name and generic drugs is unnecessary, because all are subject to the same standards:
All medications are characterized because they are capable of producing a response, this has several ways of being interpreted:
What one expects from the medication when administered (clinical experiment as a requirement to market). The effectiveness implies ideal conditions of use and this should be displayed before the drug goes on the market for the regulatory agency granted permission marketing where it will be sold.
This applies to a small number of selected patients and requires:
- Supply guarantee and adhesion.
- Medication administration education
This means the safety of medications and implies the therapeutic result, but in real conditions of use, in the usual clinical practice.
The drug must face all stages of the disease, takes into account different socioeconomic aspects and is applied in a large number of patients.
- Supply and adhesion
- Information for medication administration
- Poly pharmacy
It tells us how much it costs to produce the result in health and is very useful for the health system. The efficiency is derived / calculated:
- Cost minimization
- Cost effectiveness
- Cost / benefit
- Cost / utility
Theeffectiveness and effectiveness depend not only on the medication but also on the patient : biological, psychological and social aspects.
WHO GUARANTEES THAT THE MEDICINES HAVE QUALITY REQUIREMENTS?
‘Pharmacopoeia’ is the valid international technical document that establishes the requirements that medicines must have to be marketed.
In each country it is the Technical Director (pharmaceutical chemist) who is responsible for the quality of all medications before the law.
In Colombia, INVIMA is the REGULATOR entity.
DRUG USE CHAIN
The prescription of the medication must be: readable, complete, and accessible. Delivery: complete and timely dispensation. Use factors influence: storage, administration, adhesion.
The drug enters the body as a drug and has a series of biological interactions (such as being individual). The use in each individual is different.
The medicine is expected to be effective and safe. If it is not, the pharmacist diagnoses the use chain to identify why it was not effective or safe.
In Colombia, medicines must comply with Decree 677 of 1995, which regulates from manufacturing to marketing and distribution. These conditions are the same for all medications. “The quality of medicines must be unique” (Decree 677).
In order for a generic drug to be manufactured, it is required that the patent that protects the innovator has expired. Each country assumes this policy differently. To Colombia, after the signing of the FTA with the USA. In the US, he was forced to accept these patents for 10 and then for 20 years.
However, there are medications that are very important for public health and when a patent restricts the manufacture of a drug in a certain country, there are some flexibilities in international intellectual property rights treaties:
Compulsory license: allows other laboratories to manufacture generic medicines and make prices cheaper.
Such was the case of Imatinib, in Colombia. Meet the ‘Imatinib Declaration of Public Interest’
Parallel imports: the country does not have the capacity to manufacture the medicine, but it can import it and get it at a cheaper price.
INVESTIGATIONS AND SOME FIGURES
WHO establishes a maximum of 8% of sampled drugs that do not meet quality requirements? Colombia is between 4% and 6%. This shows that the medicines in Colombia are of good quality and that the national industry manufactures quality generic medicines.
The INVIMA program ‘Demonstrates quality’ aims to verify compliance with the technical requirements of the drugs consumed in the country in its marketing stage.
Research and publications show that not all are 100% effective. Post-marketing studies and evaluating the therapeutic results of all products, not only generic ones, but also innovative ones are suggested.
EFFECTIVENESS AND PRICE
Some claim that generic drugs are less effective, less safe or sometimes require a higher dose.
No medication is 100% effective. This depends on factors such as supply, adhesion, storage, administration, among others. Each human being is different, therefore, there are different manifestations of diseases and each individual must be prescribed the appropriate medication. Otherwise we would all use the same medications.
Generic drugs do not cost less because they are of lower quality; Other factors in the cost structure determine the price of medicines.
The price is structured according to what the person or the State is willing to pay.
This denies that when a drug costs less it is because it contains less of its active substance or that it is of lower quality or effectiveness.