By: Ruth Olivares and Olga Torres.
On September 21 of this year, Decree Number 11-2021 of the Congress of the Republic of Guatemala, National Emergency Law for the Attention of the Covid 19 Pandemic, was published in the Official Gazette, which aims to establish the legal provisions for the acquisition in the national and international market of medicines, goods, supplies, services, medical and surgical material, or others, destined to the control of the pandemic and attention to patients with Covid.
Among the most relevant aspects of this Law, the following should be highlighted:
1. The mandatory use of the GUATECOMPRAS System is established, as well as the agility of the procurement process due to the urgency caused.
2. A Basic List of Goods and Services is established (medicines, hospital equipment, laboratory supplies, hospital services, oxygen, personal protection equipment, among others).
3. Manuals of rules and procedures for procurement and contracting shall be issued by the Ministries and Boards of Directors of the entities involved, in the application of this Law and its Regulations.
4. The following are indicated as procurement and contracting modalities:
– Competitive purchasing with electronic bidding
– Open health contract
5. Imported goods and supplies may be purchased directly from manufacturers and authorized distributors of goods and services included in the basic list.
6. The Ministry of Public Health and the Guatemalan Institute of Social Security is ordered to update their purchasing plan with the new budget allocations.
7. All non-conformities arising from the awards of the present Law shall be submitted electronically.
8. Authorization is hereby granted to hire temporary personnel necessary to comply to attend patients affected by Covid 19.
9. As of the entry into force of the Law, the Ministry of Health and the Guatemalan Institute of Social Security must report at the end of each month on the acquisitions made under the protection of the same.
10. Donations directly linked to the prevention and attention of the Covid 19 disease are declared exempt from import taxes and Value Added Tax (VAT) and customs duties.
11. Information, awareness, and dissemination campaigns on Covid 19 should be carried out, referring to the prevention of Covid 19, symptoms and danger signs, as well as the importance and benefit of the Covid 19 vaccine and the care protocols to treat said disease.
12. The Ministry of Health and Social Assistance, and the Directorate of Attention and Assistance to the Consumer must publish on its website, social networks, and in a newspaper of major circulation weekly the reference prices of the goods of the basic list, as well as the reference prices of the private hospital services oriented to the Covid 19 health emergency.
These price lists will contain the category and qualities of the products, to make a comparison between equals. Weekly monitoring will also be carried out to verify compliance with reference prices.
13. Regarding HEALTH REGISTRATIONS, the Department of Regulation and Control of Pharmaceutical and Related Products will register and authorize new molecules, renewals, and related products, provided that all supporting documents are submitted, which guarantee their quality, safety, and efficacy, demonstrating that they have been authorized in other countries for emergency use and recommended for the prevention, treatment, and care of diseases caused by SARS-CoV-2.
The drugs will be registered within 15 days for synthetic molecules and within 30 days for biological or biotechnological products.
For synthetic products, it is necessary to present the authorization issued by COFEPRIS, ANMAT, ANVISA, FDA, EMA, or WHO.
For biological and biotechnological products it is required that the authorization is issued by FDA, EMA, WHO, ANMAT, ANVISA, or COFEPRIS.
During the processing of the file, the Ministry of Public Health and Social Assistance will require on only one occasion, in a single act, the correction of requirements that are considered necessary to incorporate or clarify to the file, before continuing the processing and resolution of the same.
14. In addition, the Law states that all employers must grant permission to their employees to attend specific vaccination centers, authorizing them the day with pay, for which the employee must present to the employer the card stating such fact.
The employer shall ensure that within one calendar month all workers who wish to be vaccinated are vaccinated.
This Law becomes effective on September 22, 2021, and will have a temporary application until December 31, 2021.