What are the Main Changes You Expect in the Regulatory Framework?Wed, 06/26/2019 - 13:54
2018 was a year of change in Mexico due to federal and state elections. A new government is implementing changes at all levels as newly appointed representatives take charge to achieve their objectives in healthcare. During this period, national and international companies will require a solid understanding of the regulatory environment, which only legislative experts can provide. Mexico Health Review spoke with lawyers, legal experts and consultants on the coming changes in the regulatory landscape and what companies must do to adapt to them.
Several factors impact the local healthcare environment. Changes have been made to public tenders of pharmaceuticals, imposing new requirements that do not encompass the health and the pharmaceutical industry systems in Mexico. For instance, the Mexican government now forces participants to have marketing authorization, which means only the manufacturer and not the licensee or distributor may participate in the public tender. Most manufacturing companies do not have the infrastructure to participate in the tenders themselves, causing shortages and uncertainty in tender processes. There is also a fear that players from countries with no free trade agreement with Mexico will enter the bidding process with products that may not fulfill regulatory standards. The public and private sector must work together for tenders to run smoothly and to ensure universal coverage.
Companies must be fully aware of the regulatory and economic changes in Mexico brought by the new administration and the new USMCA so they can react accordingly. This is a challenging time but also one of many opportunities for businesses. USMCA will extend copyright protection for biotechnological medications, which will impact biosimilars. Considering Mexico’s economy and its small budget for healthcare, these changes in patent law might have an impact on the health sector’s budget. The president is already developing a strategy to negotiate and pay for medicines. Hogan Lovells can capitalize on its experience to support clients as business models become increasingly complex, but also in the launching of innovative medications, M&A, compliance and foreign trade.
The country’s epidemiological transition allows us to know which diseases are more prevalent and those that are increasing in incidence. This will continue to be an important factor in the state of public health, together with the need for the industry to contribute with more products and services. Although it is unfortunate that there is prevalence of such complex diseases in Mexico, this opens the door for the pharmaceutical sector to develop increasingly innovative therapies that improve people’s quality of life. We see an opportunity to improve hospitals and clinics that already have a staff, equipment and facilities of the highest quality. Opportunities will arise as different sectors generate incentives to attract investment. KPMG sees the greatest growth potential in the hospital sector, especially with the boom in medical tourism.