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Puerto Rico Pharmaceuticals and Healthcare Report Q4 2011
Business Monitor International, Sep 2011, Pages: 81
Business Monitor International's (BMI) Puerto Rico Pharmaceuticals and Healthcare Report (Q4 2011) provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on Puerto Rico's pharmaceuticals and healthcare industry.
Puerto Rico has provided significant opportunities for drugmakers thanks to its strong manufacturing base and close ties with the US mainland. However, recent US policy developments and local tax reforms have threatened the island’s long standing reputation as tax-haven export economy. The changes have left many pharmaceuticals companies deciding whether to turn to domestic sales or simply relocate elsewhere. Despite the local government’s promises to introduce healthcare reform and kick-start a series of biotech incentives, BMI believes Puerto Rico’s macroeconomic indicators remain unstable, hampering its ability to retain foreign manufacturers and develop local demand.
Headline Expenditure Projections
- Pharmaceuticals: US$2.75bn in 2010 to US$2.81bn in 2011; +2.0% in local currency terms.
- Healthcare: US$10.81bn in 2010 to US$11.06bn in 2011; +2.3% in local currency terms.
- Medical devices: US$528mn in 2010 to US$536mn in 2011; +1.7% in local currency terms.
Business Environment Rating: In BMI’s Q411 proprietary Business Environment Rating (BER) matrix for the Americas, Puerto Rico occupies an unchanged third position, after the US and Canada. Puerto Rico’s composite score has been slightly downgraded to 64.1 out of a maximum 100. Its risks and rewards profiles are relatively evenly balanced, although concerns do exist over its economic structure and the extent of bureaucracy. However, in the long term, Puerto Rico will increasingly be challenged by Latin American countries, which are beginning to improve their business environments and increasingly offer the added bonus of massive domestic demand.
Key Trends & Developments
- In June 2011, GlaxoSmithKline (GSK) announced it will pay 37 US states and the District of Columbia a total of US$40.75mn over issues related to its Puerto Rican subsidiary, SB Pharmco. The multistate complaint came a year after a federal whistle-blower suit in which GSK agreed to pay US$750mn for a string of compromised drugs made between 2001 and 2005.
- In January 2011, US pharmaceutical company Bristol-Myers Squibb (BMS) recalled 64mn tablets of its blood pressure oral medicine Avalide (irbesartan-hydrochlorothiazide) from the US and Puerto Rico. The recall followed BMS's concerns over a potential inconsistency in levels of irbesartan, the less-soluble form of Avalide's active ingredient, which could result in slower dissolution. The company said the recall was a precautionary measure. In September 2010, Bristol-Myers recalled 62 lots, or 60 million tablets, of the drug manufactured in Puerto Rico. The latest recall involved 65 lots of Avalide manufactured in plants in Humacal, Puerto Rico and Evansville, Indiana.
- Johnson & Johnson (J&J)’s Puerto Rican manufacturing facility in Las Piedra received two warning letters from the Food and Drug Administration (FDA) over the course of 2010. These were with regard to quality issues, including odours of some consumer medicines traced to a chemical used in storage pallets. J&J recalled more than 300 million packages of OTC brands, due mostly to unsanitary conditions, faulty procedures and other shortcomings uncovered by US inspectors at the now-closed Pennsylvania facility. The company’s Las Piedras plant was also found to have deficiencies and had failed to follow written quality-control procedures.
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