BACKGROUND RESEARCH

Secteur

Impact social

Informations générales

What is the current issue?

THE WORLD TRADE Organization’s waiver is in response to globally equitable health care and, under certain circumstances, will see member countries set aside patent rights for a vaccine in response to a public health emergency. At the time of writing, this waiver is now proposed to extend to medical technology and medicines.

Een uitbreiding van het akkoord naar therapeutische middelen en diagnostiek is

At a global scale. In essence was WTO & trips a delicate balance to foster global trade. The Agreement provides ample room for members to strike a balance between the long-term benefits of incentivising innovation and the possible short-term costs of limiting access to creations of the mind. Each country has its own patent system, but there is a degree of mutual recognition by the operation of a number of treaties.

Trade-off concerning instruments de concurrence verschillende wereld regio’s: (i) marchandises, (ii) services, (iii) IP.

IP niet te onderschatten belang voor onze Europese regio (zie studies: https://euipo.europa.eu/ohimportal/nl/web/observatory/ip-contribution#ip-contribution_1, Econometrische analyse van het gebruik van systemen voor de bescherming van intellectuele eigendom in België) 3 : Les droits de propriété intellectuelle promus par l’accord tendent à protéger le savoir-faire, la technologie et la créativité qui est l’instrument de concurrence des pays du Nord. En bref, l’accord adpic et le gatt de 1994 sont supposés s’équilibrer en rencontrant les besoins respectifs des pays du « nord » et du « sud » dans le cadre du groupe d’accords de marrakech. Harmonisatie laat toe om meer vrij verkeer van goederen en diensten met een intellectueel toegevoegde waarde te hebben.

What do we want to achieve and why is this not the way to do it?

Intellectual property fuels the entire innovation system, helping researchers from universities, small biotechs and pharma companies, deliver more health breakthroughs

Intellectueel eigendom was een stimulans om jarenlang onderzoekswerk om te zetten om zo COVID-19 te kunnen aanpakken #IPMakesItHappen

Intellectual property (IP) spurs on researchers and companies to pursue new medicines by providing a framework that helps manage the risks, costs and time involved in developing them

Patents 101

A cornerstone of the patent system is that it recognises and rewards the distinct contribution of the inventor(s) to society; for example, the patent document must publish the technology in a way that allows it to be used by others, and the patent cannot legally claim any aspect of the technology that was already known. The difficulty with any IP right is that it is intangible. It cannot be physically handled, identified or handed over. In order for IP rights to be treated as property, their scope must be as clear as possible, and this scope should not be capable of being changed arbitrarily. In this way, when an IP right is sold or licensed, the buyer or licensee can be confident that what they have bought or licensed won’t disappear or be compromised easily. A robust patent system incorporates characteristics that mean decisions about patents are not arbitrary.

How do patents facilitate drug development?

Drug development is a long journey; it requires diverse skill sets and significant resources to take a drug from the initial drug discovery step through the clinical trials and other requirements for market authorisation, and then to distribute the drug to patients. To have all of these skill sets in a single organisation is impractical. For example, many of the ideas for new pharmaceuticals come from the basic research carried out by universities and medical research institutes; however, it is unfeasible for universities to build the infrastructure to develop these new pharmaceuticals through to market authorisation and then to full life-cycle commercialisation. Ultimately, this means that a number of groups can participate in the drug development process, with each group being able to contribute what they specialise in. The patent system allows the baton of the technology to be passed from group to group, in order to bring life-saving and life-enhancing technologies to patients. . Moreover, patents are available not just to inventors of breakthrough technologies, but also to those who improve existing technologies incrementally or find novel ways to use them in other applications.’

The operation of the patent system in encapsulating the technology relating to TLX101 into a tradeable and investable asset means that a bright idea supported by successful exploratory experiments at a prestigious university has the opportunity to be transformed into a potentially life-saving pharmaceutical product

Niet innovatie in het gedrang brengen / inruilen voor de belofte van gelijkere toegang die in de realiteit afhangt van zeer andere – meer run of the mill en minder sloganeske obstakels

What can we do and what will we do:

Biotech’s biggest lobby, the U.S.-based Biotechnology Innovation Organization (BIO), the Developing Countries Vaccine Manufacturers’ Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have agreed to jointly endorse the so-called Berlin Declaration, drawn up by IFPMA in July, outlining how the industry would respond to a future pandemic. The agreement was reached on Sunday at a meeting in Pune, India, on global equity and timely access; COVID-19 and beyond.

What’s the promise? They pledge to reserve an allocation of real-time production of vaccines for priority populations in lower-income countries for future global pandemics. It outlines their support for further collaborations to develop a global, sustainable manufacturing network.

What’s the demand? For these pledges to work, they need open borders for export and the removal of regulatory hurdles, the declaration says. They also call on governments to ensure countries have robust health systems and pandemic plans to deliver vaccines at scale.

Despite voluntary global agreements, and more collaboration and partnerships in biotech than ever before, a misguided understanding of equitable access remains, and the waiver will not overcome the real barriers: bottlenecks and shortages in the global supply chains, as well as strained healthcare systems in low- and middle-income countries, particularly. Research and development is complicated, and few organisations around the world can do it at scale, at low cost, and in compliance with the strict standards and public expectations of manufacturing safety.

While the support in some quarters was undoubtedly wellintentioned, it ignored the important role of IP as a means for incentivising groundbreaking research and facilitating investment into innovative biotechnology companies; IP was pilloried by some parties as a barrier to equitable distribution of vaccines and the technology transfer process to enable their manufacture.

This agreement has the potential to affect and harm small biotech companies the most as SMEs account for 307 of 357 COVID-19 therapeutics in development (86%), and most of these therapeutics potentially have other indications, which Biotechnology Innovation Organization (BIO) described in a letter to US President Joe Biden that it “may be their only path to financial viability and sustained investment to fund future R&D initiatives.”

L’accord adpic (1994) fait ainsi partie d’un ensemble d’accords uniformisant les règles du commerce international en matière institutionnelle, de marchandises, de services et de propriété intellectuelle.

Déclaration de doha (2001) permet d’attenuer les exigences de l’accord adpic à l’égard des pays les plus pauvres.

Deel van een groter geheel van akkoord binnen wto tussen pays industrialises et pays en developpement re accords multilateraux sur le commerce des marchandises (accord omc – annexe trois accords sur (i) marchandises, (ii) services, (iii) IP.

The Uruguay Round achieved that. The WTO’s TRIPS Agreement is an attempt to narrow the gaps in the way these rights are protected and enforced around the world, and to bring them under common international rules. It establishes minimum standards of protection and enforcement that each government has to give to the intellectual property held by nationals of fellow WTO members.

In fee trade : eilandjes van monopolie. Maar via trips op een geharmoniseede manier: idereen volgens dezelfde regels (relations entre les pays industrialisés – nord/nord).

TRIPS agreement

Article 7

Objectives

 The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 8

Principles

1.  Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2.  Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

Ontneemt niet de mogelijkheid om te kopieren (cfr contract with society)

Article 30

Exceptions to Rights Conferred

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Article vague qui parle d’un équilibre entre les intérêts légitimes des tiers et ceux du breveté. Quid lien avec intérêt général (art 8) dans des domaines essentiels comme la santé publique, l’alimentation et l’environnement.

L’effectivité d’une licence obligatoire dépend de multiples facteurs tels que le secteur industriel concerné, la durée de la procédure, la capacité et la volonté de transmission de savoir-faire lié à l’utilisation du brevet, et l’importance du risque commercial encouru par le licencié.

La licence obligatoire a toujours un caractère précaire. (art 31 g trips - authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur.)

31(c)  the scope and duration of such use shall be limited to the purpose for which it was authorized, 

(f)  any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; <<>> no domestic manufacturing? à exc: Doha licence

https://euipo.europa.eu/ohimportal/nl/web/observatory/ip-contribution#ip-contribution_1

This study is the latest update in a series which provides an assessment of the combined contribution to the economies of the EU from industries that make intensive use of the different types of intellectual property rights (IPR). The study confirms the economic benefits for Europe of trademarks, designs, patents, copyright, geographical indications (GI) and plant variety rights.

Main findings:

IPR-intensive industries generated 29.7% (61 million) of all jobs in the EU during the period 2017-2019.
39.4% of all employment in the EU (81 million) can be attributed, directly or indirectly, to IPR-intensive industries
47% of the total economic activity (GDP) in the EU is attributable to IPR-intensive industries, worth EUR 6.4 trillion
The contribution of IPR-intensive sectors to employment and economic activity has increased compared to the previous 2019 study
IPR-intensive industries pay significantly higher wages than other industries, with a wage premium of 41%

IPR-intensive industries accounted for most of the EU’s trade with the rest of the world and generated a trade surplus, thus helping to keep the EU's external trade balance in surplus
IPR-intensive industries also account for the bulk of trade among EU member states; such intra-EU trade exceeds EU exports to the rest of the world
Industries involved in climate change mitigation and in marketing goods and services related to sustainability and environmental protection play an important role in EU’s economy

Belgie:

Het belang van intellectuele eigendom ter bescherming van innovaties

Interessante studie in opdracht van de dienst intellectuele eigendom door IDEA consulting - Econometrische analyse van het gebruik van systemen voor de bescherming van intellectuele eigendom in België
Findings:

Uit de studie is gebleken dat de ondernemingen die IER aanvragen worden gekenmerkt door:

Hun leeftijd: hoe hoger de leeftijd van de onderneming, hoe groter het aantal en het bereik (verschillende soorten) van IER;

Hun omvang: Kmo’s hebben gemiddeld genomen minder IER (90 % van de kmo’s met 1 IER);

Hun productiviteit: meer IER geeft een hogere productiviteit;

Hun activiteit: meer IER voor bedrijven uit de groot- en detailhandel;

Daarnaast hebben ondernemingen met IER een hogere groei in tewerkstelling en een hogere productiviteit (bruto toegevoegde waarde van een bedrijf per werknemer)

De samengestelde groeivoet van bedrijven met IER is 2,5 % hoger dan bij controlebedrijven zonder IER. Bij kmo’s bedraagt dat 0,4 %.

Wat de productiviteit betreft is er gemiddeld gezien een hogere productiviteit bij bedrijven met IER, al zijn er wel verschillen afhankelijk van bijvoorbeeld de grootte en soort van IE-rechten. Zo is de productiviteit bij bedrijven met IER bijvoorbeeld 13,9 % hoger dan bij controlebedrijven zonder IER. Tegelijk is de productiviteit van grotere bedrijven hoger dan bedrijven zonder IER, maar enkel voor bedrijven die zowel octrooien als merken bezitten.

RAADPLEEG DE STUDIE EN HET ALGEMEEN OVERZICHT

GLOBAL PHARMA CEMENTS POSITION: Biotech’s biggest lobby, the U.S.-based Biotechnology Innovation Organization (BIO), the Developing Countries Vaccine Manufacturers’ Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have agreed to jointly endorse the so-called Berlin Declaration, drawn up by IFPMA in July, outlining how the industry would respond to a future pandemic. The agreement was reached on Sunday at a meeting in Pune, India, on global equity and timely access; COVID-19 and beyond.

What’s the promise? They pledge to reserve an allocation of real-time production of vaccines for priority populations in lower-income countries for future global pandemics. It outlines their support for further collaborations to develop a global, sustainable manufacturing network.

What’s the demand? For these pledges to work, they need open borders for export and the removal of regulatory hurdles, the declaration says. They also call on governments to ensure countries have robust health systems and pandemic plans to deliver vaccines at scale.

Now what? They’re calling on the G7 and G20 (November 15-16) to take up industry’s proposal as an integral part of their future pandemic planning.

Sinds 2020 vragen Zuid-Afrika en India om intellectuele eigendomsrechten op medicijnen tegen corona tijdelijk te mogen omzeilen. Zo zouden ook arme landen gepatenteerde vaccins kunnen namaken. Dat voorstel, de trips-waiver, ligt op tafel bij de Wereldhandelsorganisatie (WTO). Het zou de zelfgecreëerde schaarste van vaccins (DS 27 januari) oplossen: er staan zeker honderd productiebedrijven klaar in arme landen die snel mRNA-vaccins kunnen maken, mochten ze de exacte receptuur ontvangen. Arme landen steunden het voorstel massaal. Tegenstanders waren de VS, Europa en Zwitserland. Zij wilden de belangen van hun farmaceutische industrie niet schaden.

‘Een uitbreiding van het akkoord naar therapeutische middelen en diagnostiek is essentieel’, vult Europarlementslid Katleen Van Brempt (Vooruit) aan. ‘Nieuwe behandelingen die nu op de markt komen, zijn erg duur. Vaccins zijn slechts een onderdeel van een veel bredere strategie tegen het virus.’

Er is een levendige gemeenschap van artsen, onderzoekers en activisten die zich uitspreekt tegen vaccinapartheid. Daarmee wordt bedoeld dat rijke witte landen soms al aan hun vierde coronaprik beginnen, terwijl arme landen met zwarte of bruine bevolkingen amper spuitjes hebben. Ondanks alle wetenschappelijke argumenten pro wereldwijde vaccinatie, blijven regeringen van rijke landen de tijdelijke opheffing van patenten tegenwerken en boosters reserveren die naar groeilanden konden gaan. Covax, het initiatief dat arme landen aan spuitjes zou helpen, is klinisch dood. Dat lijkt in die landen zelfs geen gespreksonderwerp.