June 23, 2017
- Kasznar Leonardos
Recent Regulatory Framework for the Brazilian Pharmaceutical Sector
The pharmaceutical sector in Brazil is mainly regulated by the Brazilian Health Regulatory Agency (ANVISA). The Agency, created in 1999 and linked to the Ministry of Health (MoH), is responsible for the health control of all products and services under health surveillance, such as medicines, food, cosmetics, sanitizers, medical devices and others, including health services control. The Agency’s goal is to promote and protect the population’s health with coordinated actions jointly with the States’ governments by establishing rules through resolutions, guides, ordinances and others. ANVISA inspects, follows and executes policies, guidelines and actions of health surveillance in the country as well in the Brazilian borders, being considered one of the most rigorous regulatory agencies in the world.
Since the Agency’s creation, health surveillance in Brazil has always followed the main international references for the establishment of the Brazilian regulatory framework. However, ANVISA elaborates a national version, with local regulation procedures adapted to the local reality, what sometimes impacted on import or export efforts, international product registration, among other foreign trade processes given differences in some procedures and requirements. This fact, allied to the Brazilian legislative framework, local procedures of border cargo release, or even the amount of professional human resources available to the Agency leaded to some problems such as: costly importation processes of unregistered pharmaceutical products for judicial requirements; long waiting lists for product registration with no expected date grant; or even unavailability of specialty pharmaceutical products in Brazil given the lack of interest of multinational industries in facing a long and onerous registration and importation process.
Pursuing a better alignment with international regulators, at the end of 2016 ANVISA was accepted as member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH gathers regulating authorities and pharma industry associations to discuss technical and scientific issues regarding pharmaceutical products approval. From now on, ANVISA has automatic rights to nominate specialists to be part of working groups, and to contribute actively in the development and approval of ICH guidelines.
The membership decision, made in Osaka/Japan, came after a positive recommendation of the management committee, which recognized that the Brazilian Agency met satisfactorily the requirements for being an ICH member.
ANVISA has being putting efforts towards this membership since 2012, when an internal evaluation was made for the analysis of potential impacts and benefits to the country’s regulation. In addition, the Agency also considered the local industry’s opinion regarding the possible harmonization benefits and challenges. Knowing that the ICH is the main reference in the elaboration of international technical guidelines, and that ANVISA always accounted the ICH’s regulatory framework as basis for its own decisions, the Agency decided to enter with the membership request.
In an interview with Ms. Patricia Tagliari, ANVISA’s Head of International Affairs Office, it was highlighted that the reformulation process that the ICH has passed over the last two years allowed a larger inclusion of additional country regulators, considering new relevant consumer markets and important industries recent performances. These newly included agents are allowed to participate in ICH discussion process for the elaboration of the international references. This reformulation permitted a reengagement with the international initiative, what will possibly favor the local industry and lead to a maturing of the current Brazilian regulation procedures.
In general lines, the regulatory framework of both agencies has important similarities. However, differences in compositions and classifications of these guidelines were observed. Therefore, these differences must be revised, in addition to guidelines implementation, aiming at a better alignment between the organizations requirements. This effort of international best practices adequacy is already being performed, especially regarding Pharmacovigilance, Clinical Research, Common Technical Document (CTD) and Medical Dictionary for Regulatory Activities (MedDRA), and shall be completed in 5 years.
According to Ms. Tagliari, the potential benefits of this membership is the possible increased access to pharmaceutical products by the population, even in less time. The harmonization with the international guidelines makes the registration process easier for national and foreign companies to submit and have their products approved in different ICH countries members. After all, when a regulation is more aligned with international standards, it is possible to predict more easily in medium to long term the entrance of Brazilian products in foreign markets also guided by ICH. Ms Tagliari even pointed that the more aligned regulations are in different parts of the world, the more facilitated it is the decision-making of companies on how and where to invest, especially regarding the safety and efficacy of drugs.
Following the same line of reasoning of Ms. Tagliari, Mr. Anderson Ribeiro, Partner at Kasznar Leonardos Law firm, mentioned that ANVISA’s engagement with ICH is the recognition of an excellent work developed in the last 18 years by the Agency. Mr. Ribeiro pointed that the regulated sector has always stressed the relevance and potential benefits from this international alignment. The opportunity arose with the ICH’s reformulation in 2015 which allowed the organization expansion and gave ANVISA, as well as other countries regulators, the possibility of membership. One of the most expected benefits, according to Mr. Ribeiro, is the improvement of the regulatory deadlines given the harmony among the regulations and rules. In addition, another important change expected is the dossier submission in the country, which should be less laborious and more adapted to local reality. The harmonization process should improve the current mismatch regarding approval deadlines and mitigate the likelihood of judicial orders against Government to supply pharmaceutical products. These orders lead to substantial use of public resources, for instance, with several single demands for innovative therapies, without approval in the country, resulting from the current regulatory gap.
Another recent and important change in the Brazilian regulatory framework for pharmaceutical products is the concept for “Previous Consent” related to industrial property in the country.
In Brazil, patents are regulated by the National Institute of Industrial Property (in Portuguese, Instituto Nacional de Propriedade Industrial – INPI). INPI was established in 1970 and is responsible for the improvement, dissemination and management of the Brazilian system of granting and guaranteeing intellectual property rights for the industry. However, once the patent application in the country relates to pharmaceutical applications, since 2001, ANVISA is also involved in the granting process along with INPI. Thus, this jointly analysis, dependent on ANVISA’s “Previous Consent”, generated a substantial backlog in the analysis process for the pharmaceutical and biopharmaceutical applications. Patent documents were taking over 12 years or more to have a final conclusion. This important delay was mainly due to disagreements and divergences on the analysis criteria between the two organizations. Besides the delay in the analysis, this scenario was generating an uncertain and insecure environment for intellectual property in the country, which was very negative especially in terms of foreign investments.
Aiming to solve these uncertainties, the two agencies published in the beginning of 2017 a joint ordinance, that better allocates the responsibilities of each of these agencies in the patenting process. ANVISA may no longer evaluate patentability criteria, limiting its analysis to product or process risks to human health.
According to Ms. Claudia Magioli, INPI’s General Patent Coordinator, the INPI’s body of patent examiners is currently much more structured and prepared, compared to 2001 when the Previous Consent was stablished for the analysis of pharmaceutical and biopharmaceutical applications. One of the main problems generated by the Previous Consent, beyond the delays in the applications analysis, was the impact of the 10 year guarantee of market exclusivity after patent grant. Since the analysis was taking over 12 years from deposit to final decision, market exclusivity was often extended for 2 or more years. This exclusivity affected the population directly since the access to medBraicines was being hindered when reference products were the only option in the country for a prolonged time. In this sense, the recente joint ordinance between ANVISA and INPI may optimize this system since ANVISA’s recommendations will be made in the form of subside to the INPI, which will have autonomy to fulfill or not accordingly to its internal procedures. Ms. Magioli highlighted that one of the Institute’s goals is to deliver high quality exams, which may generate strong patent titles followed by legal certainty to patent owners. This chain, allied to a more systematized patenting process and following specific guidelines developed jointly with the pharma and biopharma industry, has a considerable potential to attract more investments to the country and lead to further development of the sector.
Ms. Ana Paula Santos Celidonio, partner at the Gusmão & Labrunie Intellectual Property law firm and the head of the Patent Team, also sees the joint ordinance publication positively. The agreement between the agencies may facilitate the patente granting system workflow in a scenario of years of delay and in a sector of fast technological growth such as Biotech. According to Ms. Celidonio, the ordinance may bring more certainties regarding rules and guidelines used to patent applications analysis and decisions in the pharmaceutical field.
In conclusion, the results for this recent regulatory framework may only appear in the following years. However, the perspectives are mainly positive and suggest a possible evolution in important policies for the Biopharmaceutical sector such as sanitary surveillance and industrial property.