Sanchez-DeVanny Eseverri SC updates

Medical investigations: can regulation keep up with technology?
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 12 December 2018

It is well known that the law often struggles to keep up with new products and activities. In many cases, the legal provisions which apply to regulated activities lose their applicability due to the speed with which technology enables parties to operate outside the scope of the law or the jurisdiction of the relevant authorities. This is particularly true for physical research involving humans, as advancements in communication and the transfer of data have significantly broadened the scope of such research.

The great hemp debate: marijuana or not?
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 19 September 2018

Although Mexico has some of the most stringent regulations regarding the growth, use and marketing of marijuana, this position has recently changed, as evidenced by the amendments to the General Health Law which permit the health authorities to design and execute public policies regarding the use of pharmacological derivatives of marijuana. However, the question remains as to whether hemp constitutes a narcotic under the General Health Law.

Evolution of medical marijuana regulation
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 05 September 2018

Mexico has some of the most stringent regulations regarding the growth, use and marketing of marijuana and marijuana-based products. Over the past few decades, considerable resources have been devoted to combating all activities relating to psychoactive plants. However, the government's position on the use of marijuana from a medical or pharmaceutical perspective has changed in recent years.

Pharmaceutical and medical device company M&A: regulatory and tax implications
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 22 August 2018

What happens to marketing authorisations (MAs) or sanitary registrations for pharmaceutical and medical devices may be one of the biggest questions to consider before, during and after a merger or acquisition of a legal entity active in the pharmaceutical or medical device industry. Parties undertaking a merger or acquisition which involves the transfer of an MA are advised to undertake a comprehensive analysis beforehand, as bundling the MA with other actual assets could trigger tax issues or exposure.

USTR calls on Mexico to improve pharmaceutical and medical device innovation and market access
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 23 May 2018

The Office of the United States Trade Representative recently issued its Special 301 Report. Section I.A.1 of the report, which concerns pharmaceutical and medical device innovation and market access, calls on Mexico to address pharmaceutical and medical device IP-related challenges, lists the steps that it should take in order to open its markets to IP-intensive pharmaceutical products and medical devices and encourages it to recognise the value of innovation in these fields.

M&A, asset sales and spin-offs in pharmaceutical and medical device industries – part two: marketing authorisations
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 02 May 2018

Although it is common for the parties involved in mergers, acquisitions, asset sales, spin-offs or similar activities in the pharmaceutical, medical device and other health-related industries to treat marketing authorisations as assets which are subject to the general negotiation process, this approach is controversial. If incorrect, an allocation of a monetary value to or a transfer of a marketing authorisation could be considered an invalid act between the relevant individuals or legal entities.

M&A, asset sales and spin-offs in pharmaceutical and medical device industries: what you need to know
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 25 April 2018

Mexico is the second largest market for the pharmaceutical and medical device industries in Latin America. Thus, as mergers and acquisitions, asset sales, spin-offs and similar activities in the pharmaceutical, medical device and other health-related industries are often global or at least multinational, they often affect companies that operate in Mexico. Although there have been many unfortunate situations where such activities have been delayed or cancelled, this can be avoided.

COFEPRIS issues new drug advertising guidelines
Sanchez-DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 14 March 2018

The Federal Commission for the Protection against Sanitary Risk recently published new guidelines for the authorisation of ad applications regarding prescription and over-the-counter drugs, herbal remedies and homeopathic medicines. As the guidelines include several provisions that appear to be against the General Health Law and the Health Law Regulations on Advertisements, they may give rise to a number of interesting scenarios.

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