The new regulation highlights the need for companies in the sector to implement robust crime prevention and risk management models.
The healthcare industry faces an increasingly demanding and constantly evolving regulatory landscape. This is evidenced by the entry into force of the Economic Crimes Act, which is redefining compliance policies in the country.
This regulation introduces a special regime for determining penalties for the so-called “economic crimes”, expanding the catalog of crimes for which companies may be criminally liable.
This represents a crucial step forward in the promotion of business ethics in Chile, aligning local practices with international standards.
How does the regulation impact the health industry in Chile?
The regulation now penalizes more severely conduct such as the manufacture or sale of adulterated or spoiled medicinal substances, and sanctions those who use, offer or market patented products improperly.
In addition, strict penalties are imposed for the handling of hazardous waste without the corresponding authorizations.
These changes in legislation highlight the need for companies in the healthcare sector to implement robust crime prevention and risk management models.
Likewise, with public health as a protected legal asset, organizations must comply with strict ethical and transparency standards to avoid reputational risks and sanctions that can range from fines to suspension of activities or even criminal sanctions.
In addition to regulatory challenges, the healthcare sector faces opportunities and risks related to technological advances, such as artificial intelligence, robotics and telemedicine.
These innovations have the potential to significantly improve access and quality of care, but also require constant review and updating of compliance policies to ensure data security and privacy.
In this context, it is essential for companies in the healthcare sector to have effective compliance programs in place, especially in areas such as the provision of pharmaceuticals and medical devices ordered by the public healthcare network.
In addition to these two areas, interactions in tenders, such as those conducted by the National Health Services Supply Center (Cenabast), are of particular interest and require careful management of the inherent risks.
In summary, recent regulatory changes in Chile impose new demands on companies in the healthcare industry, which must adapt their compliance policies and protocols to align with current regulations.
Fostering a corporate culture of integrity and transparency will be key to meeting these challenges and taking advantage of the opportunities offered by this dynamic sector.
For more information on these issues please contact:
Antonio Rubilar | Partner | arubilar@az.cl
Dafne Guerra | Life Science and Competition Director | dguerra@az.cl
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