The most important change proposed by the authorities is to make exceptions to the health registration of pharmaceutical products in situations of critical shortage.
After receiving the approval from the Cabinet Council, it is expected that next week, the Minister of Health, Rosario Turner Montenegro, will present before the National Assembly the Draft Law, which seeks to amend Law 1 on Medicines.
In the wholesale pharmaceutical distribution business, it is estimated that Cefa, Distribuidora Farmanova and Compañía Farmacéutica together represent about 65% of the market share.
Data from the report "Company's Corporate System", complied by the Business Intelligence Unit at CentralAmericaData, provides details on company information based on sector, main activity, imports, exports, contracts granted by the government and other data.
Arguing that the expected therapeutic effects were not proven, the Social Security of Guatemala decided to remove 107 medicines from the Basic List of Medicines.
On October 10th the Board of Directors of the Guatemalan Institute of Social Security (IGSS) announced the approval of the new Basic List of Medicines, which excludes some vitamins, antidepressants and painkillers.
Slowness in the procedures for obtaining sanitary permits and technological deficiencies in laboratories are two of the elements that are reducing competitiveness of Dominican pharmaceutical companies.
Entrepreneurs in the pharmaceutical industry in the Dominican Republic are aware that there are several aspects that could be improved in order to achieve growth in the global pharmaceutical market.Lack of coordination and dialogue with the public sector is another point that the union of companies in the sector believes should improve.
Laboratorios Paill has started the brand certification process in the Costa Rican market, and plans to start exporting its products next year.
The manufacturer of oral, injectable and ophthalmological drugs already exports its products to neighboring countries such as Guatemala, Nicaragua and Honduras, and plans to start
In Panama, pharmaceutical companies claim that the demand for a new requirement to participate in the tender could be used to exclude certain suppliers from the process.
In thetenderfor the purchase of various drugs for $241 million, the National Department of Pharmacy and Drugs (DNFD) at the Ministry of Health (Minsa) included a new requirement to participate in the process. Suppliers must submit a certificate of interchangeability for each product they wish to offer.
The Ministry of Health plans to convene, in 2017, an international public tender for the storage and distribution of medicines.
The decision was made because the Health Ministry does not have the storage capacity in its central warehouse, and as this is an activity that requires technology to store some medicines that require special handling, according to the deputy minister of Health, Sandra Pinel.
A new tender will be launched to buy dexketoprofen trometabol, after a contest was annulled due to a suspected collusive agreement between the only two bidders.
The president of the Guatemalan Social Security Institute (IGSS), Carlos Contreras, explained that"... the process was stopped due to suspicion of a collusive agreement, which may have represented unfair competition, documentation is being prepared in order to file the appropriate criminal charges. "
Pharmaceutical companies claim they have limited participation in tenders because of the slowness with which the Ministry of Health grants permits for importing medicines and medical supplies.
Although the Ministry of Health has tried to solve the problem by providing temporary special permits so that pharmacies can keep distributing certain medications, industry representatives believe that this should not be the solution to the central problem, which is the slowness with which the Directorate of Pharmacy and Drugs reviews requests for renovations and new sanitary import permits.At the moment "...At least 71 products, including medicines and hospital supplies, have expired health permits."
Businessmen in Costa Rica recognize the progress made by the government, but are calling for an acceleration in the process to eliminate the duplication of paperwork which still prevails in several institutions.
Currently we have a clear agenda to deal with the Ministry of Agriculture and the Ministry of Economy, Trade and Industry regarding outstanding issues and the reduction in the number of requirements for starting a business and those for established businesses.
In a sector worth $307 million a year, 10% of the market is supplied by laboratories in the Panamanian capital, and the remaining 90% by international pharmaceutical companies.
The biggest challenges faced by domestic enterprises are the obstacles in importing raw materials, skilled labor, and delays in the registration process, among other things. "...
Due to a Union dispute the control area of medicines and related products remains closed, preventing the import of chemicals and drugs.
The National Health Laboratory Services and the Food and Drug counter at the Ministry of Health are also closed. This situation affects the private sector, as there is no ability to complete the paperwork for "... importing of manufactured drugs, affecting not only the chemicals and pharmaceutical industry, but also food, sugar mills, agrochemicals, etc. . Fernando López, president of the Chamber of Industry of Guatemala (CIG), reported that if this situation continues losses could amount to $100 thousand (about Q776 thousand). "
Costa Rica has presented a bill that seeks to eliminate exclusivity in the importation and distribution of medicines.
The deputy leader of the Libertarian Movement has introduced a bill that aims to allow "... any person, natural or juridical to take advantage of medical registrations with the Ministry of Health and import medicines from anywhere in the world."
The healthy resistance of companies against abuses of bureaucracy, has generated an unusual and also healthy reaction from the new authorities who are quickly adopting decisions which reduce paperwork.
Editorial
The Government's decision has set a healthy precedent. The Ministry of Health has announced that it has replaced the obsolete regulations and lengthy formalities for registration of natural products, supplements and foods, with three requirements which must be submitted: "An affidavit where the company assures the characteristics of the product and meets the standards of the General Health Law, on labeling and a certificate of free sale or a health permit, depending on the origin of manufacture." With this it has been found that the state can fulfill its role of protecting the safety of citizens and at the same time establish a legal framework that is friendly to investment.
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