Final hours! Save up to 55% OFF InvestingProCLAIM SALE

EU plans easier access to generics in potential blow to big drugmakers

Published 11/23/2020, 10:54 AM
Updated 11/23/2020, 02:16 PM
© Reuters. FILE PHOTO: European Union flags flutter outside the European Commission headquarters in Brussels, Belgium

By Francesco Guarascio

BRUSSELS (Reuters) - The European Commission wants to make it easier for patients to access cheaper, generic medicines, a draft EU document seen by Reuters shows, in a move that could cut the revenues of big pharmaceutical firms.

The EU executive outlines its strategy for the sector in a document due to be published on Wednesday, with the goal of making drugs more affordable and preventing the dramatic shortages seen in the first phase of the COVID-19 pandemic in the spring.

"The Commission will consider targeted policies that support greater generic and biosimilar competition," the document says.

Generic versions of medicines are effectively cheaper copies of patented drugs and are based on the same active substances. They can only be marketed by manufacturers after intellectual property rights to the original drug expire.

The proposal says EU antitrust rules will be applied more strictly to stop patent-holding pharmaceutical companies that "hinder the entry or expansion of the more affordable medicines of their generic and biosimilar competitors".

Among the EU's possible actions, expected in 2022, are the removal of barriers that delay the entry of generics to market, increased uptake by health systems and clearer provisions for the conduct of trials on patented products to support generic marketing authorisation applications.

The Commission also says that incentives and obligations for pharma firms may be reviewed by 2022 to link them more closely to requirements for wider distribution and greater competition.

This could require drugmakers to make their patented drugs available in all EU 27 states or risk shorter period of intellectual property rights. Smaller countries are often not on the radar of big drugmakers because they are less profitable.

Amid medicines in short or no supply in the bloc are antibiotics and drugs for children and rare diseases. The Commission estimates that 95% of the more than 7,000 known rare illnesses have no treatment to date.

Shortages in the bloc were made worse in the first phase of the pandemic, amid export bans and other trade restrictions and when India curbed the export of paracetamol, the painkiller temporarily disappeared from shelves in many EU countries.

© Reuters. FILE PHOTO: EU flags flutter outside the EU Commission headquarters in Brussels

The document says measures will be introduced in 2022 to boost the EU's "strategic autonomy", including earlier notification of shortages and enhanced transparency of stocks.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.