Data Protection and Bolar in Peru in light of the EU Pharma Package

Maritza Reátegui
Partner, RODRIGO, Lima, Perú
mreategui@estudiorodrigo.com

Henri Gambier
Associate, RODRIGO Lima, Perú
mreategui@estudiorodrigo.com

Introduction

The European Union Pharma Package is composed of a new Directive and Regulation that will replace the current Directive 2001/83/EC and Regulation 726/2004 that regulate the authorisation and supervision of human medicines. Following the provisional political agreement reached between the Council and the European Parliament in December 2025, the compromise texts published in March 2026 reflect the latest agreed version of the reform. Although the new Directive and Regulation remain subject to formal adoption, the March 2026 compromise texts already define the regulatory architecture currently agreed.

The compromise text of the Directive and Regulation of the EU Pharma Package is at the forefront of the current regulatory landscape regarding the promotion of innovation in the pharmaceutical industry. Two of the regulatory instruments in the EU Pharma Package to promote innovation are data and market protection, and the application of the Bolar exemption. In particular, the EU Pharma Package proposes the modification of the data and market protection regimes, and a detailed and broadened application of the Bolar exemption.

In Peru, both of these regulatory instruments are present, however, in a simpler and more restricted formulation. A comparison of the proposed new data and market protection regime and new Bolar exemption in the compromise text of the EU Pharma Package with the current Peruvian data protection and Bolar exemption will shed light on possible regulatory lessons for Peru and on whether the Peruvian framework is sufficiently equipped to promote pharmaceutical innovation while facilitating timely access to medicines.

Data protection

Data protection is a pharmaceutical regulatory measure to avoid reliance of marketing authorisation applications of generic medicines by third parties on preclinical and clinical data previously obtained and submitted. This protection recognises the effort carried out to obtain pre-clinical and clinical data to support the efficacy and safety of medicines.

In Peru, data protection was introduced with the entry into force of the Trade Promotion Agreement (FTA) with the United States in 2009 and was consolidated by the Legislative Decree 1072 and its regulation approved by Supreme Decree 002-2009-SA. The object of protection is the data from clinical trials and pre-clinical studies that determine safety and efficacy of a medicine which contains a new chemical entity. Although the legislation provides for a five-year term of protection, this period has never been fully applied in practice, because when the Peruvian marketing authorisation is based on a prior approval abroad and is granted within six months from the filing of a complete dossier, the term is counted from the date of the first foreign approval rather than from the date of the Peruvian authorisation. As a result, in practice the effective period is always shorter than the nominal five years. The Peruvian data protection regime is also narrow in scope, because the Peruvian regulatory authority has interpreted it as applying only to small molecule new chemical entities and has not granted data protection to biologics. However, the authority’s own study of new medicines authorised in Peru between 2018 and 2024 shows sustained growth in biological medicines, while the public transparency data protection list shows that the number of products currently benefiting from active data protection is very small. This suggests that the FTA has not produced an optimal model of protection, because it established a protection period that is never fully realised in practice and, at the same time, leaves biologics outside the scope of protection, which are among the most innovative products and should receive this regulatory protection.

In comparison, the EU Pharma Package, regarding data protection, proposes a complex system of protection and incentives for innovation with a broader scope of protection. Firstly, the EU has an additional type of regulatory protection called market protection. This is a period during which generic products cannot be placed in the market, however, during the market protection period generic applications can be processed and rely on test data only if the data protection period has finalised. There are different types of regulatory protection depending on the intensity of the incentives for innovation regarding different types of medicinal products and their purpose.

The general data protection period proposed in the compromise text of the EU Pharma Package is eight years with an addition of one year of market protection. There is the option of obtaining one additional year of market protection when the medicine addresses an unmet medical need, or contains a new active substance with additional requirements that promote quality of clinical trials, and another additional year of market protection when, during the data protection period, it obtains authorisation for more therapeutic indications which bring significant clinical benefit in comparison with existing therapies. The total regulatory protection period cannot be more than 11 years in total. Pediatric Use Marketing authorisations (PUMA) get their own regulatory protection period separate from any adult marketing authorisation for the same active substance.

Also, a special transferable data protection for priority antimicrobials is part of the proposed regulations. When a priority antimicrobial is authorised the applicant upon complying with several transparency measures is granted a voucher that can be used to extend the data protection period of any authorised medicinal product for one year according to financial requisites, but this voucher can also be transferred once to another marketing authorisation holder. The grant of the voucher applies only to an antimicrobial that is effective against a multi-drug-resistant organism, has significant clinical benefit, and its mechanism of action is different from any authorised in the EU or has a new active substance that addresses a serious infection.

The EU Pharma Package also establishes a separate data protection of four years for evidence of new therapeutic indication (repurposed medicinal products) not previously authorised in the EU for an active substance that proves significant clinical benefit, and they have not previously benefitted from data protection or 25 years have elapsed since their initial authorisation.

The EU Pharma Package further provides data protection of one year for supporting evidence of an authorisation for a change of prescription of a medicinal product.

In addition, the EU Pharma Package establishes a special market exclusivity period for orphan products. This market exclusivity consists of not granting marketing authorisation of products that have a similar active substance and the same therapeutic indication. This exclusivity has a duration of nine years in general, but it can be of 11 years for breakthrough orphan products, or four years for orphan products with active substances that have a well-established medicinal use. There exists a special derogation of this market exclusivity when a third party proves the similar orphan product is safer, more effective or otherwise clinically superior. The exclusivity of nine years and 11 years can be prolonged by one year with each new therapeutic indication for a different orphan condition to a maximum of two years. The compromise text adopts a global orphan marketing approach, so later orphan marketing authorisations for other orphan indications of the same medicinal product and active substance do not trigger fresh orphan exclusivity periods, instead, they may only prolong the existing period under limited conditions.

Peru’s regime for data protection has a much narrower scope, while the EU Pharma Package proposes a differentiated system that generates various specific incentives for innovation according to public health needs. In Peru, pharmaceutical regulatory protection is a five-year data protection regime applicable to medicines that contain a new chemical entity, with no market protection layer and with a scope centred only on small molecule new chemical entities. In contrast, the EU Pharma Package keeps a dual layer of regulatory data protection plus market protection, with a baseline of eight years of data protection and one year of market protection, possible additional market protection rewards, a separate four-year repurposing data protection route, a transferable antimicrobial voucher, a special orphan market exclusivity regime, and a PUMA data protection.

In light of the EU Pharma Package, Peru could learn that regulatory protection should be more differentiated to promote innovation according to public health policies, rather than tied exclusively to small molecule new chemical entities. Instead of a narrow scope, Peru could consider a broad system of differentiated incentives for biologics, orphan products, repurposing, pediatric uses, or priority public-health products.

Bolar exemption

Traditionally, the Bolar exemption is a patent infringement exemption where any party can use a patent of a pharmaceutical product only to carry out necessary activities to obtain the marketing authorisation for a pharmaceutical product. In essence, this exemption seeks to avoid the regulatory processes delay post patent expiry entry of generics and become a de facto extension of the monopoly of the patent holder by enabling the use of the patent before it expires to conduct the necessary preparatory regulatory activities that permit generics to be offered into the market immediately after the patent expires.

In Peru, the Bolar exemption is established in the Industrial Property Law (Legislative Decree 1075) in accordance with the Andean Community Decision 486. A third party can manufacture, use, sell, offer for sale, import or export a pharmaceutical product protected by patent exclusively to generate the information necessary to support the application for regulatory approval to market a pharmaceutical.

In the compromise text of the EU Pharma Package, the Bolar exemption is more detailed and broader. It establishes that patent rights over pharmaceutical products are not infringed upon when:

1. the necessary studies, trials and other activities are conducted for the purposes of obtaining a marketing authorisation of medicinal products;
2. conducting health technology assessments;
3. obtaining pricing and reimbursement approval;
4. complying with practical requirements referred to activities in points (1) to (3); and
5. submitting an application on procurement tenders that do not entail the sale or offering for sale during the patent protection period.

Peru’s Bolar exemption is narrower than the proposed regime in the EU Pharma Package. In Peru it mainly allows use of patented matter to generate the information needed for regulatory approval. The proposed EU Pharma Package maintains this purpose but makes the exemption broader and more detailed, extending it beyond marketing authorisation to health technology assessments, pricing and reimbursement, and procurement tender activities.

In light of the EU Pharma Package, Peru could learn that a Bolar exemption should reflect how medicines actually reach patients in practice. A Bolar exemption should protect all the preparatory regulatory steps that matter in practice for actual access after patent expiry, not just the generation of the information necessary to support the marketing authorisation application. In Peru, mass access to pharmaceuticals also depends on health technology evaluations and public purchasing. The EU Pharma Package shows that a Bolar exemption limited to preparing the registration file may still pose obstacles to effective entry to market of generics once a patent expires.

Conclusion

The comparison between Peru and the EU Pharma Package shows two different regulatory models. Peru has adopted a more limited model, under which data protection is confined to a five-year period for medicines containing a new chemical entity, and the Bolar exemption is essentially restricted to acts necessary to obtain marketing authorisation. By contrast, the EU Pharma Package moves toward a functional and public-policy oriented model, in which regulatory protection and exceptions to patent rights favour therapeutic value, unmet medical needs, antimicrobial resistance, pediatric development, orphan conditions, and the practical steps required for effective market entry. Considering the EU Pharma Package, a more functional and public-policy oriented Peruvian framework could better utilise regulatory incentives to align the market with public health priorities.