AMERICAS: EL SALVADOR
NEW MEDICINES ACT IN EL SALVADOR
Author: Marcela Mancía Dada, Romero Pineda & Asociados
The "Medicines Act" was passed by Legislative Decree No. 1088, dated February 22nd, 2012, enacted by the President of the Republic on March 2, 2012 and came into force on April 2, 2012.
This New Medicines Act is intended to regulate and lower drug costs (branded or generic), improve quality control of medicines, unite various existing regulations related to pharmaceutical products, cosmetics registration and substances with therapeutic action, create the National Drugs Division (NDD) as the governing body to ensure and verify compliance with the law and regulate pharmacies, pharmacy employees and their relationships with doctors.
The National Drug Division will be responsible for the registration process and post-registration control of pharmaceutical products, any other pharmaceutical products, cosmetics and substances of therapeutic action. The Medicines Act will also generate big changes by including matters previously covered under the Code of Health Laws and Regulations.
Some of the most significant aspects arising from the new Medicines Act are:
When prescribing medicines, doctors must include the brand name of the drug and its generic name. This requirement was also established in the Health Code (Art. 14, paragraph 2).
It prevents pharmacies from instructing doctors that work for them to write prescriptions.
The Act prohibits drug peddling, except for drugs sold over the counter or without medical prescription.
The manufacture, import, export, distribution, marketing, storage, transportation, dispensing, prescribing and promotion of drugs, raw materials or medical equipment must be authorized by the NDD. We have underlined this since it is noteworthy because there is no mention of the other substances for therapeutic purposes or cosmetics.
Labeling and Advertising Technical Requirements will be established by the NDD and for their creation, it will be important to respect the Technical Regulations for Labeling Pharmaceutical Products (RTC71.01.36: 03) and Cosmetics (RTC 11.01.02:04).
Within the prohibitions of the Act applicable to pharmacies (Art. 57, paragraph f) it is noteworthy: "Use labels, coupons and gift certificates, as a business strategy for prescribing, dispensing or selling drugs to the public preferentially, and any other form of incentive that seeks to obtain the prescribing, dispensing or sale to the public for their drugs preferentially.” This means that benefit programs to consumers are not permitted if consumers are incentivized to buy a particular product through promotions that offer an equal product, benefits of medical examinations or other activities used by most laboratories to achieve preference for their products by consumers.
Promotion and advertisement can only be made for Products sold over the counter or without medical prescription with previous authorization from the NDD.
Advertisements of all pharmaceuticals have to be regulated and approved by the new National Drugs Division. However the regulation of advertisements can only be applied to the pharmaceuticals that are not sold under medical prescription.
No products sold under medical prescription can be associated with any kind of promotion or advertising. Therefore, any promotional or point of sales materials, such as brochures, flyers, promotional merchandise or signage relating to these medicines, must be removed from drugstores and pharmacies.
The Medicines Act provides that prices for any referenced medicines should be in line and consistent with costs provided in Central America and Panama. Specifically: the highest price in El Salvador cannot exceed the regional average price, [and] which may not exceed three to five times the international reference price set by the World Health Organization (excluding free sale products). In this provision, businesses will have to wait for the issuance of regulations for specific pricing guidance. 20. The penalties for not complying with the law will be fines, suspensions, revocations of authorization granted by the NDD and cancellation of the products' registrations. Fines will depend on the type of offense ranging from 10 to 200 times the minimum wages for the urban trade and services sector. Oral and written warnings previously regulated in the Health Code (Art. 287) no longer apply since the regulated minimum penalty will be a fine.
A 6-month period is given to NDD to prepare all necessary regulations for implementation of the Act.
At present, we are waiting issuance of the regulations necessary to implement the Medicines Act. In addition, there are possible changes being discussed in various sectors of the economy that would propose amendments to the Act. Any amendments would require submission to and approval by the Legislature. We will keep you informed of developments upon their occurrence.