DATE GENERALE DESPRE GENERICE
About generic medicine
Generic medicines are the therapeutic equivalent to original pharmaceutical products whose patent expired. They contain the same active substance as the original product, being their equivalent in dose, concentration, administration mean, safety, efficiency and therapeutic indications.
A generic medicine is marketed in accordance to international patent laws. The product is identified by Common International Denomination (DCI) or by its own name. Generic medicines are used on large scale in many EU countries for cost-efficient treatment programs. They are prescribed by doctors as efficient alternatives to more expensive innovative pharmaceutical products.
Generic medicine – quality pharmaceutical treatment at accessible prices.
Generic medicines offer the same quality, safety and efficiency as the original products. European or national authorities strictly control them before issuing certificates and approving their marketing.
Usually, a generic medicine is 20% – 90% less expensive than the original one. In addition, the fact that generic medicines are available at lower prices decreases the price of the original medicines by creating competition on the market, which offers access to pharmaceutical treatment to patients.
Generic medicines- tradition in excellence
Generic medicine producing companies meet the international criteria on quality, safety and efficiency of medicines. In fact, all the medicine producing plants are audited and certified with the quality norms Good Manufacturing Practices (GMP) by the National Agency of Medicines and Medical devices (ANMDM).
Generic medicines- strict compliance of bioequivalence.
The key factor in creating a generic medicine is establishing bioequivalence. The bioequivalence implies that, from scientific point of view, the generic medicine and original product have the same rate and biological availability of the active substance in the body when the medicine is administrated in the same quantity. Therefore, the generic medicine and original product must be equally efficient.
Generic Medicines – benefits for society
Whereas all EU countries register more need for medical assistance, the generic medicines play a major role in the society by providing access to quality pharmaceutical treatment for patients at accessible costs.
A real competition between generic medicines and original products is crucial for decreasing the allocated costs for pharmaceutical treatment and also stimulate innovation.
Generic medicine – commitment for future
The aging population and the accelerated increase of medical assistance costs are key factors forcing governments from all over the world to carefully analyze all aspects on supplying medical assistance services. Generic medicines offer a cost-efficient solution for controlling the segment with the largest cost growth–the pharmaceutical treatment.
1.What are generic medicines?
Generic medicines are the therapeutic equivalent of pharmaceutical products whose certificates expired. The generic medicines contain the identical active substances with the original ones, being used to treat the same conditions as the original products.
2.Are the generic medicines different from the original ones?
Generic medicines contain the same active substances as the original products. Considering the dose, concentration, administration means, safety, efficiency and therapeutic indications, they are equivalent to the original ones.
3.Who verifies the quality, safety and efficiency of a generic medicine?
In order to obtain the marketing approval, pharmaceutical companies need to prove that international criteria on quality, safety and efficiency of medicines are met. Al sites of the manufacturing medicine are audited and certified with quality norms Good Manufacturing Practices (GMP) by the National Agency of Medicine and of Medical devices (ANMDM).
4.Are the generic medicines as good as the original ones?
Yes, generic medicines are equally efficient as the original ones. They have identical dose, concentration, administration means, safety, efficiency and therapeutical indications.
5.Are the generic medicines cheaper than the original ones?
The prices for generic medicines are by 20%-80% lower than the original ones. In Romania, by Ministry of Health Order no. 75/2009, the price of a generic medicine cannot exceed 65% of the original medicine’s price whose generic it is. The lower price of the generic medicines provides extensive and equal access to therapeutical first line solutions for all chronic diseases. In Europe, generic medicines play a primary role in providing sustainability and efficiency to health systems. It is estimated that the use of generic medicines leads to annual savings of over 30 billion Euros for patients and the health public budgets.
6.When a generic medicine can enter the market?
A company can develop a generic medicine, for the purpose of selling it, only after the certificates for the relevant original medicine expired.
7.For how long is a certificate for an original pharmaceutical product valid?
As in other industries, the standard certificate is valid for 20 years. In the specific case of the pharmaceutical industry, this term can be extended by up to five years through an Additional Protection Certificate.
8.Can a medicine have more than one certificate?
Yes, pharmaceutical products can have more than one certificate. In addition, one certificate for a new usage (“indication”) or formula can block the registration or market access for a generic medicine in case the primary certificate expired.
9.How long does it take to register a generic medicine in European Union?
Usually, registration for a generic medicine takes approximately 1-2 years but it can take longer. The generic medicine producers invest a lot of time and financial resources for product development. This process, occurring prior to the marketing of the product, can take more years. Moreover, in many EU member states, the market access of generic as well as original medicines is postponed due to the waiting period for price fixing and reimbursement level.
10.Do generic medicine companies have access to original product data?
No. Applications for generic medicine do not use data included in the registration file of the original product. Generic medicine producers cultivate their own research and development activity. Generic medicine developed by producers must then be approved in accordance to the same EU rules used for the original products.