Tagged with M

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from the Civil and Criminal Codes, and it is personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Any sign distinguishing goods and services on the market shall constitute a mark. Signs capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging, or wrapping may…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred.   2. When are they likely to come into force? Uncertain.

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point…

Global In conversation at ESMO 2024 in Barcelona, Astellas Chief Medical Officer Tadaaki Taniguchi lays out some of the company’s most promising recent oncology data, his hopes around how Astellas’ modality-based strategy will ultimately bring “meaningfully differentiated” therapies to patients, and why next-generation treatments stand to reshape the cancer care paradigm.…

Mexico Hernán Porcile, General Manager of Takeda Mexico, discusses the company’s innovative therapies, regulatory strategies, and the integration of ” “Takeda-ism” within the Mexican cultural context. He emphasizes Takeda’s commitment to sustainability, diversity, and collaboration with local healthcare ecosystems.   Respecting our legacy as a Japanese company while adapting to the…

Switzerland Hans Peter Borger of Spirig HealthCare discusses the company’s integration with the STADA Group and its focus on generics, consumer healthcare, and specialty markets, including Parkinson’s and rare diseases. He emphasises the importance of a growth mindset and a value-driven culture in navigating Switzerland’s regulatory landscape.   We are committed…

France In conversation at ESMO 2024, Pierre Fabre’s R&D Head Francesco Hofmann outlines some of the key data readouts for the company’s oncology portfolio from this year’s conference, how it is looking to expand its R&D portfolio via business development deals and biotech partnerships, and the spaces in which a mid-sized…

Mexico Oswaldo Bernal explains how Mexico is BMS’ top-performing market in Latin America (outside of Brazil) and plays a significant role in the company’s global growth strategy. He also discusses how Mexican patients face hurdles in accessing new treatments due to low health investment and lengthy regulatory approval processes, as well…

USA Troubled gene sequencing firm Illumina has announced a new strategy to accelerate growth. Under the leadership of CEO Jacob Thaysen, Illumina hopes to turn the page on a recent history marked by antitrust issues following its decision to acquire former spin-off company Grail.   Illumina’s ambitious new strategy comes after…