Contents:

MARKET OUTLOOK Current market size Unique 5-Year market projections to 2013 Market outlook Comment & rating, covering 8 key areas such as use of generic drugs, intellectual property, pricing and the health systems Market structure Statistical data on imports and exports Market developments, covering recent and impending developments with respect to key issues such as regulation, health facilities, funding and government policy Key national data projections BACKGROUND DATA Population data, including growth trends and age structure Demographic indicators detailing principal causes of death and morbidity HEALTHCARE SYSTEM Organisation & administration Health expenditure - Expenditure by source of funding and type Hospital services - Hospital data such as beds by type, region, specialty, patient admissions and surgical procedures Outpatient care Medical personnel - Data on healthcare professionals covering such areas as doctors by specialty, nursing staff and dentists ACCESSING THE PHARMA MARKET Regulatory environment Distribution and trade fair information Domestic production Company information CONTACT DETAILS For healthcare organisations and trade associations

Summary:

Highlights from the region ARGENTINA The Argentinian pharmaceutical market plummeted in 2002, but has since recovered. Pharmaceutical production, distribution and the market are dominated by the local pharmaceutical manufacturers. In comparison with other Latin American markets, local pharmaceutical production is still very high. Local producers are increasing their export capabilities, with Argentina being the third leading Latin American exporter of pharmaceuticals. Foreign producers of branded pharmaceuticals are recovering from the peso’s devaluation. Small copycat producers, which have traditionally served the public sector, are shaking up the industry. The government is using price negotiations as a short-term cost-containment but drug producers aim to negotiate price rises of up to 10% in 2008. BRAZIL The local currency has appreciated, increasing the pharmaceutical market in dollar values. Despite cost-containment measures, there is considerable potential for growth. The local industry will continue to maximise its opportunities in the generic sector. The public sector is small in comparison to the pharmacy sector, but is growing, representing between 15.0% and 20.0% by value. About one fifth of this is spent on antiretrovirals. Brazil issued its first compulsory licence for Merck Sharp & Dohme’s Stocrin (efavirenz) in May 2007. Since then, the international pharmaceutical industry has been more cautious with investments in Brazil, with a tendency to shift production and clinical studies development to Mexico and Argentina. The implementation of the PAC Saúde programme in February 2008 is expected to strengthen the Unified Health System (SUS). CHILE Protectionism towards the domestic industry characterises the Chilean pharmaceutical market, which ranks sixth in the region. Domestic producers are the leaders in the private pharmacy sector, controlled by three pharmacy chains. The domestic industry relies on raw material imports, whilst exports are restricted to Andean markets due to a lack of quality standards. The industry is slowly meeting GMP practices, with a new deadline in 2008. Domestic manufacturing is expected to shift from copycat products to branded products under licence from multinationals; bioequivalence tests are being performed for selected active ingredients. Most of the international drug companies are importers in Chile. TRIPS-related patent enforcements and the new health reform will increase pharmaceutical spending in the long term. COLOMBIA The Colombian pharmaceutical market is the fifth largest in the region. The healthcare reform programme has been instrumental in boosting consumption of pharmaceutical products, but growth has been largely in volume terms. The majority of the market is supplied by the relatively well-developed domestic industry; most of the subsidiaries of international drug producers have closed their manufacturing facilities. The largest indigenous manufacturers are engaged in the production of generic copycats. The deficit in the balance of pharmaceutical trade has increased since the introduction of intellectual property rights in the mid 1990s. In April 2008, an argument between the US White House and Congress stopped the trade agreement with Colombia being fast-tracked and perhaps delayed it indefinitely; this is a setback for Uribe’s government. CUBA The seventy-five-year-old Raul Castro became President of Cuba in February 2008, after his brother Fidel declined to serve another term in office. The US announced that, although there is potential for change, and despite the new leader, the trade embargo will remain until Cuba becomes a democracy. Cuba has a relatively strong domestic pharmaceutical and biotechnological industry, which supplies both domestic and export markets; Cuba has close health ties with Venezuela. In December 2007 the director of QUIMEFA confirmed that there will be millions of dollars of investments to improve and increase pharmaceutical production, and the plans include seven new plants which will benefit from the latest technology. Domestic GMP-compliant production concentrates on generic pharmaceuticals to treat HIV/AIDS, circulatory diseases & cancer and vaccines; selected pharmaceuticals meet bioequivalence standards. MEXICO Mexico is the second leading Latin American market, behind Brazil. International and domestic producers compete in the internal market, and continue to increase exports towards the USA and Latin America. In recent years, drug prices have risen, particularly in the private pharmacy sector. Monopolistic practices exercised by leading research-based producers and distributors are being targeted by Calderon’s government. The public sector is using its bargaining power to bring prices down and, in fact, launched a commission to centralise drug purchases in April 2008. A renewal process for drug registrations started in February 2008; the Mexican market will only have patented and bioequivalent generic medicines in the market by 2010. Under a new decree published in January 2008, Article 168 of the General Health Law has not been modified; the Secretary of Economy wanted to incorporate the elimination of plant requirements to import drugs. PERU The Peruvian pharmaceutical market is the seventh largest in the region. Historically, growth in pharmaceutical expenditure has been positive but unstable. There are preferential custom duties and product registration towards Latin American countries. Due to a lack of local infrastructure and quality standards, exports are comparatively insignificant. Imports of original drugs are almost exclusively consumed by the private pharmacy sector, whilst locally produced branded and unbranded generics are consumed by the private pharmacy and public sectors. The public sector is making efforts to co-ordinate central drug purchases. The approval of the USA - Peru Trade Promotion Agreement (PTPA) in December 2007 will result in further intellectual property compliance by the pharmaceutical industry. VENEZUELA Recent economic performance has boosted out-of-pocket drug expenditure. The Barrio Adentro Mission, which is the basis of the new national healthcare system, has also increased drug spending, particularly in the public sector. In spite of price controls on around one third of the private pharmacy sector and restricted access to foreign exchange, the pharmaceutical market continues to grow and ranks fourth in the region. Future market expansion will depend on economic performance, the implementation of the Barrio Adentro Mission, exchange controls and import levels. The USTR maintains Venezuela on the Priority Watch List in 2008. Data exclusivity and linkage problems remain. Following its move to join MERCOSUR, Venezuela withdrew from the Andean Community in April 2006, raising questions about the country’s ability to perform its international IP obligations. USTR notes that Venezuela has not issued a patent for a foreign drug since 2003.

Countries Covered

-Argentina -Brazil -Chile -Colombia -Cuba -Mexico -Peru -Venezuela