IHS Global Insight Perspective | |
Significance | The MoH has announced it is about to send to parliament for discussion the creation of the new Drug Regulator Agency (Anamed) in Chile, setting out drug regulation as a priority in the country. |
Implications | Amongst its different functions, the main impact is going to be seen in the generic drug market, as bioequivalence requirements will come up. Clinical research and developing local and international partnerships are also among the main objectives. |
Outlook | This is positive news for the pharmaceutical sector, especially international pharmaceutical companies, which have been involved in long judicial battles against local manufacturers of "me-too" drugs without bioequivalence accreditation. In addition, the presence of a Chilean counterpart for Anvisa, Anmat and other Latin American agencies can foster co-operation within a regional framework. |
The long-awaited creation of the National Drug Regulator Agency in Chile is about to become a reality, after the Health Minister, Jaime Manalich, announced his organisation was about to present the law to the Chilean parliament, which aims to set up the Agencia Nacional de Medicamentos (National Agency of Medicines, Anamed). The initiative is an old aspiration of the Chilean pharmaceutical sector that incredibly, given the context of its developed economy by Latin American standards, still does not have an independent organisation capable of setting out minimum quality drug standards, such as Anvisa in Brazil.
Currently, the responsibility of drug regulation lies with the Instituto Nacional de Salud Publica (National Institute of Public Health, ISP), which is a high-profile entity, but which in parallel has many other attributions such as to act as a National Reference Laboratory. That situation has caused drug regulation to not be regarded as a priority in the country, with many local pharmaceutical companies manufacturing and commercialising so-called generic drugs which in reality are "me-too" drugs, given the absence of legislation to enforce bioequivalence requirements. This fact has meant that Chile historically has been regarded by the US Commerce Chamber and international pharmaceutical companies as a hot spot of weak intellectual property rights, despite the advanced regulation that exists in other sectors of the economy.
According to the information released by the Minister of Health, the Vision of Anamed is to be a public technical-scientific institution of excellence in health, modern, and recognised by all the Chilean population as the institution which ensures the efficacy, safety and quality of drugs, cosmetics and medical products that are subject to sanitary control in Chile. According to the description of its mission, this vision will be achieved throughout the oversight of the entire development process, from research to marketing. The main strategic areas of ANAMED will be:
- Oversight of Good Manufacturing Practices (GMP);
- Enforcing bioequivalence requirements;
- Set out a new norm for biologics and biotechnology products;
- Increase and strengthen pharmacovigilance;
- Establish the framework for clinical research of drug studies in humans;
- Improve the management and process of the Agency;
- Strengthen relationships with other Latin American drug agencies such as Anmat (Argentina) and Anvisa (Brazil);
- Strengthen relationship with other public and private actors, locally and internationally.
The Chilean authorities have unveiled their priorities for the new agency during the present year, which include accrediting through GMP at least 50% of the laboratories in the country, maintaining a new drug registration time of 152 days on average, maintaining a similar drug registration time of 125 days on average, setting up three new centres of bioequivalence assessment and if possible one more (Universidad de Chile) and introducing bioequivalence as a requirement in the national public tenders conducted by the National Warehouse and Drug Purchaser Cenabast.
Outlook and Implications
The confirmation of the creation of Anamed is good news for the Chilean and Latin American pharmaceutical sector. Chile, even though it is not part of the top Latin American markets in terms of pharmaceuticals (currently ranked sixth in the region in terms of volume sales by IMS 2011) is especially attractive in certain areas, such as oncology and metabolic diseases, due to the lack of price regulation. When drugs have a demonstrated innovative and therapeutic value, companies which manage to include their drugs as part of the national reimbursement scheme can get access to higher prices. The new agency will have the responsibility to increase co-operation between public and private organisations, locally or internationally. Within the country there are expectations that ANAMED could promote engagement between pharmaceutical companies and universities, or other research groups, boosting start-up projects and drug innovation. Internationally, the existence of a Chilean counterpart might open the opportunity to scale up the dialogue amongst Latin American regulators, in order to try to set up a regional framework including big players such as Brazil and Mexico.
International pharmaceutical companies and many political and technical actors have regarded the creation of ANAMED as positive. Given no price regulation is considered, the raise in the standards of bioequivalence will help Chile to comply with international intellectual property regulation, which still regards Chile as part of the black list due to copycat drugs. Most importantly however, it will make sure that Chilean citizens are receiving generic drugs that share the criteria of bioequivalence with their originators. Concerns about the real political independence of the agency have been raised, however, but by any measure, this is positive news for the emerging market sector.