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In brief

Law No. 31225, titled “Law promoting the acquisition and provision of the Sars-Cov-2 Coronavirus vaccine as a vaccination health strategy to ensure timely access” has been published in the Official Journal “El Peruano” on 21 June 2021.


In summary, the law provides the following for private sector companies:

  1. The Ministry of Health authorizes the private sector to import or purchase SARS-CoV-2 coronavirus vaccines.
  2. The deadline for issuing this authorization is seven calendar days.
  3. Private companies must make these vaccines available to the National Center for the Supply of Strategic Resources (CENARES in Spanish) of the Ministry of Health, so that they can be distributed free of charge in accordance with the provisions of Law 310911.
  4. Private companies “will have the priority of immunizing their staff” but within the National Vaccination Plan established by Ministerial Resolution N° 848-2020 / MINSA2.
  5. The Ministry of Health will coordinate with private health entities for the implementation of this vaccination process for private companies.
  6. Vaccines purchased by companies will be considered as an Income Tax deductible expense “as long as the health emergency lasts.”
  7. The Ministry of Economy and Finance will “evaluate” if the tariff on these vaccines is waived.
  8. Finally, this law must be regulated within a period of no more than 10 calendar days.

As can be seen, the regulation will need to clarify some aspects of the law, including the following:

  1. How will the vaccination process itself move forward? If private companies deliver vaccines to CENARES and then request for “priority,” a procedure for accessing such prioritization should be envisaged.
  2. What is the legal mechanism that authorizes private companies to purchase and import vaccines (permit, license, conditional registration)?
  3. How will this “authorization” procedure operate? Will it be in charge of DIGEMID?

Finally, what will happen if the ruling of the Judiciary declaring the National Vaccination Plan inapplicable to private companies is definitively confirmed should be borne in mind.

We trust that this information is relevant to you and your company. If you need to delve into the subject, please contact us

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1. “Law that guarantees access to preventive and curative treatment of SARS-COV-2 Coronavirus disease and other diseases that give rise to national health emergencies and other pandemics declared by the World Health Organization.”

2. However, by judgment dated 31 May 2021, the Second Specialized Court in Civil Matters of La Molina and Cieneguilla (via amparo action) has declared the following rules INAPPLICABLE to private sector companies: a) article 5 of Law 31091, which establishes compliance with the vaccination scheme with the participation of regional governments and the health sectors to guarantee access and coverage; and b) Ministerial Resolution No. 848-2020 / MINSA, approving the National Vaccination Plan. This sentence has been appealed.

Author

Luis Alonso Garcia has more than 25 years of experience practicing in intellectual property law. Mr. Garcia has been vice minister of Foreign Trade in Peru. He was in charge of the negotiation of intellectual property in the free trade agreement between Peru and the United States. He has successfully led the offices for Peru’s trademarks and patents and has chaired the Court for Intellectual Property in INDECOPI. Mr. Garcia is also an intellectual property lecturer in different universities in Peru.

Author

Rosmery is an associate in Estudio Echecopar. She has a solid background in intellectual property and life sciences. She provides regulatory counseling and advice on pharmaceutical products, medical devices, cosmetics, absorbent products for personal hygiene, household hygiene products, food and beverages, and agrochemicals. Her intellectual property practice includes trademarks, patents and copyright, with emphasis in the management of portfolios and litigation on patents and copyright.

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