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Global Business Update to strengthen national industrial manufacturing, reduce players in Brazil's generics market are Brazilian companies dependency on product importations, and achieve better Medley, EMS Sigma Pharma, Eurofarma Laboratórios, and control over expenditure. To date, 34 technology transfer Aché Laboratórios Farmacêuticos and Indian multinational partnerships between public and private laboratories have Ranbaxy Laboratories Ltd. been established for the production of 28 drugs (including WHAT DOES THIS MEAN FOR YOUR COMPANY? Pramipexole, Tenofovir, Clozapine, Quetiapine, Olanzapine, In the coming years, the Tacrolimus, Rivastigmine, favorable healthcare enviand Donepezil), and ronment will allow local 3 vaccines. According to Brazil Key Facts companies and generthe Ministry of Health, at ic drug makers to rapleast 20 new partnerships idly increase their marare expected over the ket share and negatively next four years, including impact on international biological products and manufacturers of brandmedical devices. ed products. Moreover, In the medium and key decision makers are long term, stakeholdexpected to adopt stricter ers are not only seeking regulatory, pricing, and internal development, reimbursement regulabut they are also hoping tions to further develop to increase competitiveinternal pharmaceutical ness of Brazilian pharma manufacturing. companies abroad. A furAs a direct consequence, ther step in this direction market access in Brazil will was made early this year become increasingly challenging for international pharmaceutical when the Brazilian president, Dilma Rousseff, announced companies, making it necessary for global businesses to evaluate that the recently created Brazilian Enterprise for Research and adapt their business strategy to local realities. Strategic offerand Industrial Innovation (Embrapii) will be responsible for ings, including technology transfer agreements, will be a key factor promoting partnerships between public innovative research to secure continued market sales growth in the following years. institutions and private companies to create new products and International pharmaceutical companies should also consider processes. financial/outcome-based pricing agreements and other alternative INCREASING GENERICS MARKET SHARE approaches to meet the increasing demand for access to healthGenerics were introduced in Brazil 30 years ago with distrust care without impacting excessively on budget. from both general consumers and prescribers. Nowadays, the Keeping track of legislative, pricing, and reimbursement generics market share in Brazil is still lower than in other changes; foreseeing how competitors' launches will impact markets (e.g. 26 percent in 2012 compared to 66 percent in your portfolio; and linking Brazil to global decisions and Germany and 60 percent in the United Kingdom and U.S.), but international referencing pricing are essential to identifying it is expected to increase to 45 percent by 2020. According to and bending gaps and trends shaping the pharmaceutical the Pro-Generics Association, by the end of this year the market market in your favor. share of generic drugs should increase to 30 percent. Trying to capitalize on this broad and increasing interest from About the Author decision makers, the generic drugs industry is proposing that Davide Zaganelli is senior consultant and global market access manager at Alliance Life Sciences Consulting new generic drugs, such as those whose patents have expired Group. With a keen interest in Latin America, he manages and do not have other generic competition in market, should market access, pricing, and business strategy activities be granted priority by ANVISA (National Health Surveillance in both emerging and established markets, supporting Agency Brazil) in order to decrease regulatory time for pharma and biotech companies in maximizing effectiveness and product potential. authorization and increase access to healthcare. The prominent 58 LifeScienceLeader.com October 2013