Policies & Legislation
South Korea includes data exclusivity period for paediatric drugs approved abroad
As of 5 May 2021, South Korea has updated the re-examination periods for post-marketing surveillance (PMS) of approved drugs. This now includes a four-year re-examination period for PMS that can now be granted for paediatric drugs approved based on both ‘domestic’ and ‘foreign’ clinical trials.
MERCOSUR: new tariff for biological and biosimilar without Latin equity
Within the pharmaceutical industry, the biosimilars business is growing and consolidating both internationally and locally. It is within this framework that MERCOSUR announced the new tariff to be implemented.
New trade agreement between Mexico, the US and Canada
The new trade agreement between Mexico, the US and Canada, now called the T-MEC entered into force on 1 July 2020.
Use of generic drugs is promoted in Peru
To promote the use of generic medicines in Peru, on 31 October 2019, the Executive Branch published regulations through Supreme Decree No. 026-2019-SA, which established mechanisms to ensure access to lower-cost medicines. The decree recognizes the need to adopt measures that favour the population’s access to essential medicines, biological products, and medical devices.
A new dawn for China’s patent law
China has made changes to its patent law which were enacted on 1 June 2021. The revisions mean China’s new patent law system resembles the US Hatch-Waxman approach and include a patent linkage system and patent term extensions.
Affordable Care Act to stand in USA
On 17 June 2021, the US Supreme Court ruled to uphold the Affordable Care Act (ACA) and Obamacare. This ensures the current pathway for biosimilars to reach the US market will be maintained which will provide access to cheaper versions of expensive biological therapies.
Proposals for the commercialisation of generics move forward in Chile
The project known as the Medicines Law 2, led by a Joint Commission, seeks to settle discrepancies between senators and deputies regarding the sale of bioequivalent and generic medicines in Chile. The project, which is in its third stage, amends the Health Code to regulate generic drugs in order to prevent the vertical integration of pharmaceutical companies and pharmacies. In this way, it seeks to solve some pending issues left by the current drug legislation.
President Biden signs ‘Advancing Education on Biosimilars Act’
US President Joe Biden has signed the Advancing Education on Biosimilars Act of 2021, authorizing the Food and Drug Administration (FDA) to educate patients and healthcare providers about the benefits of biosimilars. This follows the reintroduction of the Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act), which will increase reimbursement for biosimilar drugs.
Teva under scrutiny in EU pay-for-delay investigation
In March 2021, the European Commission opened a formal investigation into alleged anti-competitive – ‘pay-for-delay’ – conduct, by the Israeli generics giant Teva Pharmaceutical Industries (Teva).
EU and Brazil health authorities enter partnership
Health regulatory authorities in the European Union (EU) and Brazil entered a partnership to ensure mutual recognition and regulatory harmonization to improve human and animal health.
