You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

October 3, 2016

Data Exclusivity for Biologics in Vietnam: Present and Future Regulations

Subscribe to Updates

Biologics are composed of complex, large molecules, as opposed to the small molecules that make up conventional chemically derived drugs. Because of the complex nature of biologics, clinical trials and data collections are expensive to produce and require a heightened level of data exclusivity protection beyond those of a patent to incentivize biologic producers to continue research on new biologics.

Vietnam has a period of data exclusivity for all drugs including biologics; however, this period does not consist of complete data exclusivity, rather only the protection of physical data from the assessment of other generic companies. In practice, such data protection periods do not help to prevent the granting of Marketing Authorization for generics, including biosimilars.

Under current legislation in Vietnam, biologics are broadly defined as medicinal products of biological origin used for the purposes of prophylaxis, therapy, and the diagnosis of human diseases. Consequently, both biologics and biosimilars are considered to be biologics and have the same data exclusivity management by competent authorities. Accordingly, both biologics and biosimilars must have clinical data to apply for a Marketing Authorization; therefore, biosimilar companies do not need to use the clinical data of biologics companies for regulatory submissions. Because of this, the “data exclusivity” period in Vietnam is not practical in practice.

The National Assembly of Vietnam passed the new Law on Pharmacy, which provides different definitions and management measurements for biologics and biosimilars. Consequently, biosimilars manufacturers may not be required to provide clinical data because they can rely on the clinical data of innovative biologics producers to prove the safety and efficacy of the drugs. Overall, Vietnam’s increased level of involvement in trade agreements, such as the Trans-Pacific Partnership (TPP) and the European Union-Vietnam Free Trade Agreement (EVFTA), and the new Law on Pharmacy will require slight (but important) changes  in Vietnam’s current data exclusivity protections of biologics.

Current Protections

Currently, Vietnam does not have any specific regulations enacted that protect data exclusivity for biologics; however, biologics are subjected to the same data protection as small molecule drugs. There are two different Vietnamese regulations that address data exclusivity for drugs:

  1. Article 128 of the Law on Intellectual Property (Art. 128 of the IP Law) requires that when applicants for a license for trading in or circulating pharmaceuticals is required to supply test results or other data that the applicant requests to be kept secret, the licensing body must not grant licenses to subsequent applicants who use the secret data without the prior applicant’s consent.
  2. Circular No. 05/2010/TT-BYT (Circular 05) allows for a five-year period of data exclusivity from the granting of marketing authorization for drugs that are new chemical entities (NCE). Parties who file their registration dossier by referring to the data of a previous party that is protected under Circular 05, will be denied marketing authorization by the DAV if they file the data without the permission of the previous party and without proof that the NCE was created independently of the previous party’s data.

There is some debate in Vietnam as to whether Art. 128 of the IP Law and Circular 05 are in conflict. Circular 05 only prevents the DAV from granting marketing authorization to parties who refer to the data in the dossier of a previous party. To get around this regulation, subsequent parties can simply not refer to the previous party’s dossier and have marketing authorization granted.

Under Circular 44/2015/TT-BYT, all biologics, including biosimilars, are required to have their trial data submitted in registration dossiers for marketing authorization. In practice, however, the data protection regulations are of little help in protecting biologic reference products for the following two reasons:

  1. By their nature, biosimilars are not identical copies of their originators. In addition to a thorough analytical assessment, head-to-head clinical studies against the originator are needed to establish comparability to the originator; therefore, biosimilars are often required to have their own trial data for regulatory submissions. Consequently, there is no need to use the protected data of the originator.

  2. Vietnam has no definition of biosimilars or specific regulations about requirements for trial data for biosimilars; therefore, some biosimilars with very limited trial data may be approved for marketing authorization.

Expected Challenges in Protection: TPP

Article 18.50 of the TPP protects undisclosed tests and other data submitted as a condition for granting marketing approval for a new pharmaceutical product. This is accomplished by not allowing third parties to submit the information in the undisclosed tests and other data, without the consent of the party that submitted the data, in order to market the same or similar product.  In the TPP there is a specific provision that applies the protection afforded by Article 18.50 to biologics. In particular, Article 18.51 of the TPP provides effective market protection for new biologics through either:

  1. Data protection as indicated in Article 18.50 for at least eight years from the date of first marketing authorization; or, alternatively
  2. Data protection as indicated in Article 18.50 for at least five years from the date of first marketing authorization, combined with other measures. 


The main difference between the TPP and Vietnam’s current regulations is that for biologic drugs, the TPP provides an extended term of data protection, eight years as opposed to five years, or alternatively, five years combined with other additional measures. It is anticipated that the corresponding provisions of the IP Law and the Pharmacy Law of Vietnam will likely be amended to provide measures to prevent generic drug producers from applying for marketing authorization, instead of only maintaining confidentiality of the clinical data of innovators. The five-year duration of data protection is likely to be preserved. Actually, the DAV had plan to build a legislation to provide measures to prevent generic drug producers from applying for marketing authorization.

Expected Challenges in Protection: EVFTA

In Article 9 of the EVFTA, the agreement requires the parties to issue the legal framework for protecting “undisclosed test[s] and other data” against unfair commercial use. The agreement also requires that the period for protection shall not be less than five years from the date on which the Party grants approval to the patent owner that produced the data. In Vietnam, only undisclosed tests and trade secrets are currently protected, while the EVFTA requires that the parties open their scope of protection to include not only undisclosed tests, but also “other data.”

In response to Article 9 of the EVFTA, the DAV should consider amending domestic regulations to protect all data that applicants of new drugs submit to the DAV while requesting marketing authorization, not just the submitted trial data.

Conclusion

Overall, biologics manufacturers, both internationally and domestically, can expect to see no increase in the amount of time the DAV will grant data exclusivity for biologics. In comparison to data exclusivity protections in countries like the U.S., where the period of exclusivity is granted for twelve years, biologic manufacturers are at a bit of a disadvantage in Vietnam due to the lessened time of protection; however, biosimilar producers will be able to release their products in much shorter periods of time, thus allowing for biologics to be available at lower prices.

If Vietnam does decide to not grant biosimilar manufacturers marketing authorization within the period of data exclusivity, biologic manufacturers will stand to benefit by being the sole producer of the biologic during that period. Biologic manufacturers will also benefit from the potential increase in the type of data protected under the EVFTA, as protections may extend from just trial data to all types of data submitted.

Related Professionals

Industries

Life Sciences

Practices

Intellectual Property

Regulatory Affairs

Location

RELATED INSIGHTS​ 

February 21, 2023
On December 28, 2022, the Ministry of Health of Laos issued Decision No. 3789/MOH on the Control of Hemp for Medication and Products (the “Decision”). The Decision approves the regulated cultivation, extraction, production, processing, storage, distribution, utilization, import-export, and transport of hemp. The Decision also authorizes the use of hemp and hemp-related products by the general population, although use of certain products is limited to those with medical prescriptions. Background In 2019, the Lao government established an ad hoc committee to consider the legalization of cannabis, as reported previously. The government permitted certain local companies to grow cannabis in specific zones under pilot programs, although it continued to strictly prohibit the use and commercialization, as well as consumption, of cannabis-related products, regardless of the level of psychoactive tetrahydrocannabinol (THC) in the products. Overview of the Decision The Decision was issued by the Ministry of Health (which led the ad hoc committee) and permits authorized companies to engage in certain activities involving the use of hemp and the consumption of hemp and hemp-related products. The Decision defines hemp (“porkeo” in Lao) as a “plant that belongs to the same family as ganja and bears the scientific name Cannabis Sativa L. (Cannabis sativa L. subsp. sativa var. sativa) which is a subspecies of ganja (Cannabis Sativa L.).” This definition aims at differentiating hemp from the general definition of ganja or marijuana, which continues to be listed as a prohibited narcotic in Laos. The Law on Narcotics (2007) and the Penal Code (2017) still prohibit the production, trade and use of all types of cannabis. These laws will need to be amended to ensure that they are aligned with changes set out in the Decision.  Authorized Hemp Activities The Decision allows approved companies to engage in the cultivation, extraction, production, processing, storage,
Read More
February 9, 2023
Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the
Read More
January 27, 2023
The opening weeks of 2023 have already seen a sharp increase in enforcement against violations of product labeling and advertising rules in Cambodia, in line with a notice issued by the country’s Directorate-General for Consumer Protection, Competition, and Fraud Repression (CCF) last year. Since the Law on Consumer Protection was adopted in 2019, a major legislative push has been seen, with general rules coming out focusing on providing consumers with sufficient information on products and services, for example via product labeling or advertising rules. Then, more detailed regulations were adopted for specific product categories, for example for food products and cosmetics. Khmer language requirements have been a key feature of the recently adopted rules on advertising and labeling. Despite the Khmer language mandates in consumer protection laws and regulations, enforcement and compliance was low. Most products on the market—especially imports—did not comply with the language requirement. In line with the revamped regulatory framework, the CCF has increased its enforcement, enabled by recent substantial budget increases. They have adopted clear implementing regulations for their officers to enforce in a practical yet effective manner, and they have been issuing notices reminding companies to comply with the new rules. A September 2022 notice announced that increased CCF enforcement of product labeling rules would start on January 1, 2023. As noted above, this has already proven to be true, and enforcement is now proceeding in earnest. Companies should take heed of this notice and ensure compliance with the Khmer language requirements (detailed below), as the CCF has shown that it readily acts against violators, from small retailers to large conglomerates. Khmer Language Requirement A sub-decree issued November 4, 2022 requires all commercial advertising of products and services—by any channel—to use Khmer as the primary language. If foreign-language text is used in advertisements, it
Read More
January 10, 2023
On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.
Read More