Upcoming regulatory reforms in Mexican pharma. Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
INITIATIVE BIOTECHNOLOGY MEDICINES (amends article 222 Bis of the General Health Law)
Public health institutions should establish an effective differentiation mechanism to ensure adequate pharmacovigilance and continuity of medical treatment, thus preventing an automatic substitution of biotechnology / biocompatible drugs, without due medical prescription.
INITIATIVE SELF-PRESCRIPTION (amends articles 112 and 310 of the General Health Law)
The aim of the initiative is to avoid self-medication. In order to do this, it proposes: 1) to indicate that health education should include within its objectives the orientation and training of the population on the risk of self-medication and self-prescription; and, 2) establish that the advertising of over the counter products and herbal remedies should: I) include the legend –self-medication can aggravate the disease; and (II) disseminate the general characteristics of secondary reactions.
INITIATIVE MEDICAL DEVICES (reform various regulations of the General Health Law)
The initiative aims to regulate the use of medical devices. Among the proposed, it is worth noting: 1) considering the medical team, prosthetics, diagnostic agents and supplies of dental use as such devices; 2) to replace the term “essential nutrients for health” with “medical devices”; 3) indicate that for sale or supply, as well as for importation, they must have sanitary authorization; and, 4) to emphasize that the indications of its use will be detailed in the instructions of the corresponding product, in printed or electronic form.
INITIATIVE TELEMEDICINE (amends article 77 Bis of the General Health Law)
The initiative aims to implement telemedicine through electronic means. For this purpose it suggests: 1) to specify that the medical prescriptions will be issued in digital form; and; 2) determine that this modality may be implemented by the public and private agencies and entities of the National Health System, subject to Mexican regulatory and official regulations issued by the COFEPRIS.
Recently, the Mexican government approved several amendments to the Tax Law. In summary, digital health platform providers could be taxed even though the medical service itself is exempt from tax. Agreements between Telemedicine providers and digital platforms can help to determine whether these entities fall within the scope of the law.
INITIATIVE CANNABIS REGULATION (New General Health Law Regulation on Sanitary Control of Cannabis)
On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives was published in the Federal Official Gazette.
The new Cannabis Regulation is intended to regulate, promote, and monitor the use of cannabis and its derivatives for medicinal use. The regulation includes provisions regarding primary production, research, manufacturing of pharmacological derivatives and medicines, distribution, advertising, prescription, and commercialization. This regulation come into force on January 13, 2020.
INITIATIVE PRICE REGULATION
The aim of this eventual regulation is to regulate the prices of drugs in order to ensure the proper access, the prices of drugs would be reviewed and evaluated every year or at any time if necessary, based on the economic, technical or therapeutic conditions.
INITIAL HEALTHCARE STRATEGY
The goal of this strategy is providing universal and free coverage for medicines and medical care. And would be eventually implemented as follow, involving reforms and changes in the corresponding regulation. The following are the key goals outlined in the strategy by the current Mexican President:
- Federalization of the health system through the gradual signature of agreements with the 32 States, which will surrender their faculties to govern over health matters to the federation.
- The Mexican Social Security Institute (IMSS), the Mexican Civil Service Social Security and Services Institute (ISSSTE) and other State Social Security entities will provide equal and non-discriminatory services to all persons, regardless of social security status.
- The Federal National Formulary will be abolished.
- The United Nations will observe the public bids for acquisition of medicines, equipment and medical devices.
- Preference of national public bids over international (open to international companies or products).
- Increase of the health budget by 50 billion pesos but in the general national budget there was no significant increase to the health sector.
2. When are they likely to come into force?
It is worth mentioning that rules and practices are changing almost on a day by day basis, yet it is also uncertain when and how the relevant proposals would be decided and enacted. At this point in time, considering the recent change of government there are a lot of proposals for reform including many other fields, other than health. Thus, the proposals concerning health are being carefully reviewed and often discussed and may conclude this process of evaluation in an average time of 6 months since this government is very active in these matters.