Healthcare, Regulatory and Reimbursement Landscape - Mexico, New Report Launched

The healthcare market of Mexico has significant potential for growth. The increasing elderly population, prevalence of non-communicable diseases, improvements in regulatory guidelines, government support for the healthcare sector, and the North American Free Trade Agreement, which assures its members protection of intellectual property rights, provide the impetus for the growth of the Mexican pharmaceutical market.

The pharmaceutical market was valued at approximately $10 billion in 2008 and is projected to reach approximately $22.5 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 7%.

In 2010, the Mexican pharmaceutical market was the 14th largest pharmaceutical market in the world and second in Latin America after Brazil (Daiichi Sankyo, News Release, August 2, 2011).

The prevalence of non-communicable disease is increasing due to the increasing elderly population, which accounted for approximately 7% of the population in 2013, as well as changes to food and lifestyle habits.

The government has been successful in the implementing steps needed to achieve universal healthcare coverage, such as reforms in the System of Social Protection in Health (Sistema de Protección Social en Salud). In 2012, approximately 56 million people in Mexico were covered by Public Health Insurance (Seguro Popular, PHI) (Bristol, 2014; OECD, 2011). The rest of the population uses either social security coverage for healthcare or private healthcare insurance.

Regulatory regulations have attracted significant investment in Mexico’s pharmaceutical industry. The pharmaceutical sector had a cumulative Foreign Direct Investment (FDI) of $2.9 billion from 2005 to 2012. In 2012, Mexico received a total of $981m in FDI in pharmaceutical sector. The US, Luxemburg, Ireland, Canada and Japan were main investors in the Mexican industry.

The share of multi-national companies in Mexico is high, compared with the share of domestic companies in the total pharmaceutical market. The leading multi-national companies are Pfizer, Merck, Sanofi and Novartis, the leading domestic players are Genomma Lab Internacional and Laboratorios Liomont.

The Mexican medical device market was valued at $2.8 billion in 2008 and is projected to grow at a CAGR of 5.7% to an estimated $5.4 billion in 2020. Ophthalmic devices (15.4%), nephrology and urology devices (14.8%), and orthopedic devices (14.5%) were the major segments in the medical device market in 2013. The key challenges being faced by the medical device industry in Mexico are Mexico’s dependency on the US for the import of devices and low expenditure on R&D by the domestic sector.

The Mexican regulatory authority provides a transparent and strong regulatory environment with a shorter lag time to facilitate the approval of pharmaceutical products and medical devices.

In Mexico, the Federal Commission for Protection against Health Risks (Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), working under the guidance of Ministry of Health (Secretaría de Salud, Salud), is the main regulatory authority for pharmaceutical products and medical devices. Marketing authorization of new drugs and medical devices requires the execution of good laboratory practices and satisfactory compliance reviews for safety, efficacy and quality of drugs by COFEPRIS and Salud. To manufacture pharmaceutical products in Mexico, the major requirement is a Good Manufacturing Practice (GMP) certificate, which is provided by COFEPRIS after inspection of the establishment and review of the relevant documents. COFEPRIS also regulates the exports and imports of pharmaceutical products in Mexico. The regulatory authority provides a transparent and strong regulatory environment with a shorter lag time than the US and EU. However, it is a challenge for the applicant to fill out application forms in Spanish and pay a high amount of fees to the regulatory authorities. Registration of a new molecule (for the first time in Mexico) takes 90 to 180 days, and drugs previously registered in Mexico take 40 to 180 days. The approval process for a molecule already registered in another country takes 60 to 240 days. The approval time period is noticeably less than that of regulatory agencies of developed countries, such as the US Food and Drug Administration (FDA) and the European Medicines Agency.

Increasing access to healthcare facilities through an open, premium-based system is driving healthcare services in Mexico, and high out-of-pocket payment is a major concern.

The Mexican government provides easy access to healthcare facilities to the population through its high number of primary care services, hospitals, and national specialty institutions with highly sophisticated medical care. The primary care centers are prevalent in rural as well as urban areas to provide healthcare services.

In 2012, the share of public healthcare expenditure in Mexico was valued at 52%, while the private expenditure share was at 48% (World Bank, 2014r). The share of healthcare expenditure shows the high Out-of-Pocket (OOP) payment system in Mexico. The Mexican population enjoys public healthcare coverage either through social coverage for healthcare or federal- and state-funded services. The major social insurances are the Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS) and the Institute of Security and Social Services for State Workers (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, ISSSTE). The state-and federal-funded public insurance is covered under PHI and Oportunidades. In 2012, IMSS and ISSSTE covered more than 50% of the population of Mexico (Knaul et al, 2012).

Political stability and government initiatives will act as drivers for the economic growth of Mexico.

The National Action Party (Partido Acción Nacional, PAN) party stepped down after the general elections in 2012 when the Political hegemony of the Institutional Revolutionary Party (Partido Revolucionario Institucional, PRI) won the election.

Mexico is one of the members of the Organization for Economic Co-operation and Development (OECD), due to its healthy economy. The annual Gross Domestic Product (GDP) growth rate was approximately 1.1% in 2013. Subdued activity in the industrial sector, especially in the construction sector, and lower public expenditure growth were the main contributors to the average economic performance. In 2013, the government unveiled a plan to invest in infrastructure projects over the following five years, which could start boosting construction in 2014. Additionally, the recent energy and utility sector reforms will begin to have a positive effect over the medium-term, improving economic projections. On the back of the recent reforms, the economic activity is likely to accelerate in the 2014–2015 period, after an average performance in 2013 (Bank of Nova Scotia, 2014).

Know more about this report at : http://mrr.cm/ZWA