Intergroup

Official Intergroup related publications.

Open Letter to the Members of the Board of the WTO

To the attention of Mr. Tim Yeend,
Chef de Cabinet and Principle Advisor to Director-General
World Trade Organization

Bruxelles, 16 September 2020


Subject: On the risk of TRIPS to create regulatory barriers to medical innovation

Dear Mr. Tim Yeend,

In light of the “vaccine nationalism” and buy-outs of the broad-spectrum antiviral medication “Remdesivir”, much of the emphasis on intellectual property issues revolved around coronavirus has focused on immunizations and medicines, and we couldn’t stand aside from
this timely discussion.

Earlier this month, South Africa issued a communication titled “Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach to TRIPS Flexibilities.” It was pointed out that the COVID-19 response required looking beyond patents towards a more “integrated approach to TRIPS flexibilities that include other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets” (IP/C/W/666).

“TRIPS flexibilities” that are usually used to refer to exceptions allowing countries to override global IP rules for public health reason have been used mainly in regard to patents. However, as the communication argues, the scope of the flexibilities should also be extended
to other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets. As such, the recommendations submitted by South Africa are cross-field as they also touch upon the production and distribution of essential medical devices such as masks, ventilators, and personal protective equipment.

The risk of TRIPS is to create regulatory barriers that go well behind the pharmaceutical industries. Some examples of innovations that are supposed to be shared but face regulatory barriers go beyond pharmaceuticals to AI algorithms for apps and 3D-printed ventilator valves.

As a quick reminder, this can include so-called compulsory licensing when a government authorizes a manufacturer to copy another’s patented medicine. There are other grey areas still to be addressed over compulsory licensing as well as there are many ways to make easier access to vaccines: for example, a mutual recognition of FDA and EMA and other agencies and fast-tracking procedures for some type of medicines.

During tough times, decision-makers are requested to restore certainty to the greatest extent possible. Moreover, this crisis compels us to be one step ahead and anticipate issues.

Looking forward to your swift reaction,
Gianna GANCIA MEP
Anna BONFRISCO MEP
Fulvio MARTUSCIELLO MEP
Massimiliano SALINI MEP
Matteo ADINOLFI MEP
Salvatore DE MEO MEP
Antonio Tajani MEP
Hermann Tertsch MEP
Marlazy Aguilar MEP
Ivan Stefanec MEP
Stefania Zambelli MEP
Fred Roeder, managing director of the Consumer Choice Center

Think of the children! How to find cures for rare and children diseases.

The European Commission just published a working document assessing the EU’s orphan and pediatric drug strategies. Read here why incentives for research are key to extending patients’ lives:

A rare disease is a medical condition that meets the criteria defined in Article 3 of Regulation (EC) No 141/2000; a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU. Although so-called rare diseases affect a limited number of people per disease, collectively they affect one person in every 17 people within Europe. There are over 7,000 different rare diseases patients suffer from.

Regulators see an ‘imbalance of risk and reward’ for the industry to find cures and treatments for those diseases. Hence US, Japanese and EU regulators increased options for longer market exclusivity for drugs tackling diseases in children and rare diseases. In 2000, Regulation (EC) No 141/2000 and  2006 Regulation (EC) No 1901/2006 were adopted by the European Commission. The ‘standard’ incentives provided by the general legislative framework for pharmaceuticals in the EU are 10 years of market protection and 20 years of patent protection. For pediatric and orphan drugs manufacturers can apply for extended market exclusivity.

The purpose of this strategy is to improve and expedite patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. Adding prolonged exclusivity worked: A massive increase in orphan drugs could be seen in the last 20 years! Between 2012 and 2017 over three times as many orphan drugs entered the EU compared to 2000-2005. The EU Commission estimated that between 200,000 and 440,000 additional quality-adjusted life years were gained thanks to more incentives for these drugs.

Added IP Protection for Orphan Drugs correlates with more drugs entering the market

Voices who call now for less protection of orphan and pediatric drugs want to undo the successes of the last two decades. The 142 orphan medicines authorized between 2000 and 2017 have helped up to 6.3 million patients in the EU to either cure or cope with their health conditions.

But there are still millions of patients waiting for a breakthrough that can help to treat their rare or pediatric disease – For this, we need to have incentives and not populism. Intellectual property is key in allowing the inventor and her investors to reward them for their massive risk they undertook in trying to find a cure or treatment for a rare disease. The EU’s approach to orphan and pediatric drugs by increasing incentives for inventors and manufacturers has worked. The successes of the past 20 years should not be undermined by populist calls to nationalize research and IP. If we care about patients with rare diseases, we should not question the importance of protecting intellectual property but see it as a precondition for future innovations.

To sum it up: Think of the children and allow medical innovation to take place!

Licensing laws in the public health sector

On June 17th 2020, the Innovation, Brands and Intellectual Property Intergroup sent an open letter Commissioner for Trade Phil Hogan about the COVID-19 crisis and the risk of Licensing Laws to the production and supply of essential goods to the population.

Under licensing laws, a government has the power to revoke patent rights from innovators or companies if a discovery they made would provide vital treatment or protection related to a national health emergency. Under these laws, another organization can also reproduce and distribute the product without prior consent from the patent-holder. If the patent owner does not comply, they may face heavy fines from the government.

“If European and third-countries’ companies are prevented from retaining their patent licenses, this could hinder furtherly the production and supply of essential goods to the population.”

“A compulsory licensing bill could place even more barriers for pharmaceutical groups trying to make a profit, which could further discourage these kinds of companies from registering in any EU Member State.”

Compulsory licensing is threatening to move the goalposts on how intellectual property rights are protected; it should only be used in a state of national emergency. However, the interpretation of the notion of “health emergency” can be fuzzy.

“There are other grey areas still to be addressed over compulsory licensing as well as there are many ways to make easier access to vaccines: for example, a mutual recognition of FDA and EMA and fast-tracking procedures for some type of medicines. During tough times, decision-makers are requested to restore certainty to the greatest extent possible. Moreover, this crisis compels us to be one step ahead and anticipate issues.”

The letter was signed by:

Gianna GANCIA MEP
Fulvio MARTUSCIELLO MEP
Lucia VUOLO MEP
Massimiliano SALINI MEP
Patrizia POIA MEP
Ivan STEFANEC MEP
Anna- Michelle ASSIMAKOPOULOU MEP
Lukas MANDL MEP
Radan KANEV MEP
Fred ROEDER, Managing Director Consumer Choice Center

FULL LETTER CAN BE SEEN BELOW:


World Intellectual Property Day 2020

On Sunday, April 26th 2020 the world celebrates the Intellectual Property Day.

On the occasion, the Innovation, Brands and Intellectual Property – The Future of Europe Intergroup led by MEP Gianna Gancia sent a letter to Ms Margrethe Vestager Executive Vice-President and Ms Mariya Gabriel Commissioner for Innovation and Research European Commission stressing the importance of safeguarding intellectual property rights.

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