The focal point of the Ministry of Health (MoH) is to increase people’s access to specific types of drugs in a well-adjusted way for the country’s economy, especially regarding medicines for highly prevalent diseases in the population or high cost treatments. To achieve this goal, the Productive Development Partnership, (in portuguese, Parceria para Desenvolvimento Produtivo – PDP), was created in 2008. The purpose of this government instrument was not only the cost savings in the drugs’ purchase, but also the industrial development of health sector in Brazil, that a long has revealed behind of international trends. The PDPs are made up through partnerships between public laboratories and private pharmaceutical companies, and they intended not only technology transfer but also allow an intra and extra-governmental environment for discussion, establishing a new form of relationship between the stakeholders.
According to data disclosed by Department of Industrial Complex and Innovation in Health (DECIIS) in October 2015, currently Brazil has 90 ongoing partnerships. It is important to highlight that in 2014 there was an update of criteria and guidelines for definition of the list of strategic products and others aspects related to these partnerships. In that way, this reorganization led to the exclusion of some PDPs that were not in line with the new rules. Of these 90 ongoing PDPs, only one is already in the process of full technology transfer, which is the vaccine against influenza, produced by the Butantan Institute in partnership with Sanofi. Additionally, 57 PDPs are in phase of project’s implementation (Phase II), and 26 are in fact beginning production steps (Phase III). Other six PDPs, focused on Research, Development and Innovation, complete the total number of ongoing agreements. Regarding the type of products, medicines are the target of most partnerships, being 77 PDPs for the production of them and the remaining 13 aimed the production of health products, which include equipment and other materials.
When looking at therapeutic areas of all existing PDPs, the vast majority are directed to oncology, viral infections and autoimmune diseases. There are 12 PDPs for the production of antiretroviral drugs, which target patients with HIV and viral hepatitis. The submission of proposals for PDPs in relation with these technologies began in 2009 and has grown over the years, achieving a significant number in 2012. An important finding is that the latter date coincides with the decline period of deaths by HIV in number and also with the falling of disease incidence rate, as reported by MoH.
Regarding oncology, eleven are the PDPs directed to the treatment of many types of tumors, such as breast, head and neck, lymphomas and others. However, the submission of proposals was more expressive in 2013, together with research advances in the field of monoclonal antibodies. With a larger number of patients using this therapy, more robust are the results related to safety and efficacy, contributing to greater indication of such treatments. Another important relevant area is that one related to autoimmune diseases, such as rheumatoid arthritis. Ten proposals were approved, with requests from 2011, with a notable increasing in number in 2013. In this context, one plausible explanation for the increase in proposal applications for biological products may be related to the drop of about a dozen patents between 2012 and 2015. Consequently, big pharmaceuticals companies, responsible for the production of these drugs, such as etanercept and rituximab, have been mobilizing and investing in these partnerships, so ensuring market share.
Currently, there are 34 partnerships involving biological products (vaccines and biopharmaceuticals) and other 43 including synthetic drugs. It worth mention that especially in 2013, when there were a boom of proposals for biologicals, national companies, such as Bionovis, Orygen and Cristália have partnered with international pharmas, aiming the submission of proposals together. This fact demonstrates the interest of Brazilian companies in acquiring new and complex technologies, which is the case of biological production, once it requires specific infrastructure and trained team.
According to the approved list of PDPs, disclosed by MoH, from 2009 to 2014, 63% of the partnerships were made exclusively between public laboratories and national private companies. In the other hand, PDPs between international companies and public laboratories correspond to 20% of the total agreement. Notably, the majority of partnerships that include international companies are for the production of biological directed to treat rare diseases or immunobiological used in vaccines. The main feature of biopharmaceuticals is that they are expensive, so the assurance of exclusive sales for the government can generate an increased demand, once more patients can have access to the treatment.
Public laboratories, in the PDPs context, have specific characteristics that define the type of products that the institution is able to receive and replicate. For the production of biological products, there is clearly a preference for institutions like Bio-Manguinhos (Fiocruz), Vital Brasil Institute and Butantan Institute. The listed institutions have, respectively, 13, 8 and 7 signed PDPs. Regarding the production of non-biological drugs, FURP-SP (Foundation for the Popular Medicine) and Farmanguinhos (Fiocruz) stand out with 18 and 12 signed contracts respectively.
The new regulatory framework published by the government in 2014 was extremely important to consolidate the PDP program, once it details the responsibilities of all involved actors and previously defines the list of strategic products. However, the supervision of each agreement must be done with great caution, so the process can be effective not only in the provision of more products to the population, as well as in the acquisition of all knowledge involved in the tech transfer.