Ministry of Health: New Provisions for Purchases of Medicines in Ecuador
The Ministry of Health has issued new regulations to authorize purchases of medicines not included in the current National Chart of Basic Medicines (“CNMB” by its Spanish initials). The regulations are mandatory upon all institutions comprising the Public Health Network (“RPIS”) and the Complementary Private Network that provides health care services to patients from the Public Network. The major aspect of the Regulations are: Application:The Regulations establish a procedure to request, assess and authorize the purchase and use of medicines not included in the CNMB in the case of emergencies and for treatment of catastrophic and rare diseases and other scarcely prevailing diseases for which it may not be possible to utilize all the therapeutic alternatives available at the CNMB.Medicines in the event of emergencies:Health care facilities that by reason of an emergency need a medicine not included in the CNMB, that is, in the event of a critical situation in a patient’s life requiring imminent actions in the next 24 hours – as long as there are scientific arguments in that the existing alternatives at the CNMB are not efficacious for the pathology concerned – may acquire and/or use the medicine immediately under responsibility of the physician who issues the prescription and of the Pharmacotherapy Committee upon the previous approval of the facility’s highest authority- Within 15 days after the emergency, official notification must be given to the National Health Under Secretary about the purchase of the medicine due to an emergency, attaching a copy of the medical history, confirmed diagnosis, the resolution from the Pharmacotherapy Committee including the advisability of the prescription, duration of treatment, the patient’s progress, and the tests made. A copy of the invoice evidencing the purchase must be also attached. - In the case of the Complementary Private Network, the notification must be sent to the highest health authority in each RPIS institution to which it renders its services.The authorization issued in an emergency should be specific for each patient. If the medicine acquired for an emergency does not meet any scientific criteria demonstrating real benefits for the case concerned, administrative sanctions will be applied. Medicines not included in the CNMB may be prescribed in emergencies as long as they are not for continuous use, chronic treatment, or for treatment with exclusively palliative purposes and not related to the critical situation menacing the patient’s life.Medicines in cases not considered emergenciesHealth care facilities requiring a medicine not included in the current CNMB in such cases not considered an emergency must deliver a request to the highest health authority of each RPIS institution. The Complementary Private Network will submit the request through such highest authority in the institution to which its provides its services. The request must include the following information, among others:- Name of the laboratory that manufactures the medicine requested and name of the company that registered the medicine with the National Health Regulation and Control Agency. - Justification for not continuing or beginning with one or more medicines included in the current CNMB.The National Directorate for Medicines and Medical Supplies will issue a report on efficacy and safety in the following cases: (i) new medicines, (ii) medicines that are part of WHO’s list of essential medicines, (iii) expansions of pharmaceutical form or concentration of essential medicines included in the current CNMB, (iv) medicines already authorized and requiring continuity, and (v) others not considered a public health priority. The resolution for authorizing or not authorizing the purchase of medicines not included in the current CNMB will be issued by the committee in charge of authorizing or not authorizing medicines not included in the CNMB. The minimum criteria to be taken into account for authorizing the purchase of medicines not included in the CNMB are, among others, the following:- The medicine must have demonstrated a minimum 5% improvement on the global quality of life measured according to a scale duly recognized for that purpose. - In the case of medicines for oncological indications, those medicines must have demonstrated a subsequent condition free from the disease during more than three months.Once the purchase has been authorized, a document following up the use of the medicine and a list of patients must be submitted from time to time. The medicine will be subject to inventory control by the health care facility. The authorization will be valid during two years and will be subject to review.Other provisions:Authorized medicines will be considered strategic medicines and will be included in the Regulated Pricing Regime. Authorized medicines may be taken into consideration for a process known as corporate inverse auction of medicines. Ministerial Decree 158 – Ministry of Health. Published in Official Register No. 160 dated January 15, 2018.
What payments should employers make to employees under Ecuadorian Law?
The following infographics includes information relating to payments to the workers and how much they represent in 2018. http://www.pbplaw.com/lo-que-debe-saber-salario-digno Warning: This newsletter by Pérez Bustamante & Ponce is not and cannot be used as legal advice or opinion since it is merely of an informative nature.
Reminder of February 2018 obligations
We remind our subscribers that the following obligations must be met in February 2018:Corporate: Submission of list of foreign companiesDomestic legal persons with foreign legal individuals among their partners or shareholders are obligated to submit the following to the Superintendency of Companies by February 5: 1.- A certificate of the legal existence of the foreign company that is a shareholder of the Ecuadorian company. This certificate must be apostilled or authenticated by an Ecuadorian consul. A complete list of all the shareholders of the foreign company, signed and certified before a Notary Public, up to the last natural person owning such rights, with an indication of the complete first and last names, the nationality and domicile of each partner, shareholder or member disclosed. 2.- If the foreign company that is a shareholder of the Ecuadorian stock corporation was listed in one or more foreign stock exchanges, it must submit an affidavit regarding this listing and the fact that the entirety of its capital is exclusively represented by registered shares, interests or securities. 3.- Powers of attorney granted by foreign shareholders or partners in Ecuadorian companies in favor of representatives domiciled in Ecuador. Foreign companies in the capacity of partners or shareholders with no permanent domicile in Ecuador must appoint an attorney-in-fact. This power of attorney must be apostilled or authenticated by an Ecuadorian consul, if it is issued in the place of domicile of the company. Tax:Submission of Personal Expense AnnexNatural persons whose deductible personal expenses exceed 50% of the basic non-taxable allowance of the valid income tax for the declared fiscal period are obligated to submit the information regarding their personal expenses corresponding to the immediately preceding year. The personal expense annex shall be submitted in the month of February pursuant to the following calendar:Ninth Digit of the Tax Identification Number (RUC for its initials in Spanish) or the Ecuadorian Identification Document Deadline for Submission1 February 102 February 123 February 144 February 165 February 186 February 207 February 228 February 249 February 260 February 28If required, a taxpayer has an obligation to submit the sales receipts reported in the personal expense annex.Submission of Annex of Shareholders, Equity-holders, Partners, Members of the Board of Directors and ManagersCompanies, branch offices of foreign companies that are residents in Ecuador and permanent establishments of non-resident foreign companies are obligated to submit the Annex of Shareholders, Equity-holders, Partners, Members of the Board of Directors and Managers (the “Shareholder Annex”) The Shareholder Annex must be submitted through the web page of the Servicio de Rentas Internas (SRI for its initials in Spanish), in general, during the month of February of the fiscal period following the one to which the information relates. Without prejudice to the relevant sanctions provided in the valid tax legal framework, failure to submit or incomplete submission has consequences in regards to the applicable tax rate for the obligated subject. In the event of any changes to the list of partners or shareholders, the Shareholder Annex must be submitted by the 28th of the following month in which the incorporation or change took place.Submission of 2014 Information regarding Foreign Monetary AssetsPersons obligated to submit information regarding monetary assets held in foreign financial entities must submit the information corresponding to 2014 by February 28, 2018. We remind of the obligation to submit this information when at least one of the following conditions is met: - The monetary assets held in foreign financial institutions register, within the fiscal period to which the information corresponds, individual or cumulative transactions equal to or greater than US$ 100,000.00 or its equivalent in foreign currency; - At any time during the fiscal period to which the information corresponds, an average monthly balance has been registered for the monetary assets held in foreign financial institutions equal to or greater than US$ 100,000.00 or its equivalent in foreign currency; - At the end of the month, the balance of the monetary assets held in foreign financial institutions is equal to or greater than US$ 100,000.00 or its equivalent in foreign currency, or - As of December 31 of the fiscal period, the balance of the monetary assets held in foreign financial institutions, individually or cumulatively, is equal to or greater than US$ 100,000.00 or its equivalent in foreign currency.  http://www.pbplaw.com/sri-obligacion-reporte-activos-monetarios-exterior/  http://www.pbplaw.com/sri-amplia-fecha-presentacion-informacion-activos-monetarios-en-extranjero/ Warning: This newsletter by Pérez Bustamante & Ponce is not and cannot be used as legal advice or opinion since it is merely of an informative nature.