EVALUATIE VAN OCTROOIBESCHERMING BIJ COVID-19 VACCINS EN DRUGS

Year 2022, , 143 - 166, 30.06.2022

Meltem Karatepe Kaya , Serkan Kaya

https://doi.org/10.55027/tfm.973422

Abstract

De uitbraak van COVID-19 werd op 11 maart 2020 door de Wereldgezondheidsorganisatie (WHO) uitgeroepen tot een wereldwijde epidemie (wereldwijde pandemie). Met deze aankondiging waarschuwde de WHO landen dat de epidemie een ongekende wereldeconomie en gezondheidscrisis vertegenwoordigt. Hoewel landen deze pandemie proberen te voorkomen met restricties en maatregelen zoals avondklokken op verschillende niveaus, thuiswerken, het sluiten van de grenzen of het toepassen van quarantaine voor buitenlanders, kan niet worden onderschreven dat deze maatregelen erg goed hebben gewerkt vanwege de maatregelen die de landen hebben genomen. beëindig de epidemie niet, maar vertraag het proces alleen. Als de epidemie een tijdje aanhoudt, zal het resultaat niet alleen de menselijke gezondheid aantasten, voornamelijk fysiek en psychisch, maar zal het ook schade veroorzaken op verschillende gebieden zoals economie, industrie, onderwijs en toerisme. Om de COVID-19-epidemie te voorkomen, die de wereld begin 2020 korte tijd heeft getroffen maar al lang aanhoudt, is de meest effectieve remedie die we op dit moment hebben de COVID-19-vaccins. Vanaf eind december 2020 zijn sommige landen die schoten kunnen bereiken begonnen met het vaccineren van kwetsbare groepen. Vanaf 18 juli 2021 blijkt dat er wereldwijd 3,66 miljard vaccindoses zijn gemaakt.
Enerzijds, terwijl sommige landen proberen om twee vaccindoses te bereiken, zijn sommige andere landen in sommige regio's, zoals in ons land, overgestapt op vaccinatie met een derde dosis. Aan de andere kant is in sommige onderontwikkelde landen, zoals Haïti, zelfs geen enkele dosis vaccin toegediend. Gezien het snel muterende karakter van het coronavirus, ligt het voor de hand dat de pandemie niet zal eindigen zonder gelijktijdige vaccinatie wereldwijd. De negatieve impact op de sectoren zal nog jaren aanhouden. Om deze reden zijn er met de verklaringen van de Wereldhandelsorganisatie en enkele wereldleiders discussies ontstaan ​​over de vraag of het voor farmaceutische bedrijven mogelijk zal zijn om af te zien van hun octrooiverplichtingen voor COVID-19-vaccins en -behandelingen. Want in deze uitzonderlijke periode waarin we ons bevinden, moet een evenwicht worden gevonden tussen de rechtsbescherming die het octrooirecht biedt aan farmaceutische bedrijven in het kader van het TRIPs-verdrag en het recht op toegang tot geneesmiddelen, een van de grondrechten van mensen. Daarom zal deze studie bespreken of een vrijstelling van de farmaceutische octrooiverplichtingen voor COVID-19-vaccins mogelijk is of niet door soortgelijke voorbeelden in de wereld te beschouwen.

Keywords

COVID-19-uitbraak, COVID-19-vaccins, opheffing van de farmaceutische octrooiverplichtingen, TRIPS-overeenkomst, dwanglicenties

PANDEMİ AŞILARI VE İLAÇLARINDA PATENT KORUMASININ DEĞERLENDİRİLMESİ

Abstract

COVID-19 salgını, Dünya Sağlık Örgütü (DSÖ) tarafından 11 Mart 2020 tarihinde dünya çapında bir salgın (küresel pandemi) olarak duyuruldu. DSÖ, bu duyuru ile ülkeleri, salgının küresel ekonomide ve sağlıkta benzeri görülmemiş bir krizi temsil ettiği konusunda uyardı. Her ne kadar ülkeler çeşitli seviyelerde almış oldukları sokağa çıkma yasakları, dönüşümlü ya da evden çalışma, sınırların kapatılması ya da yabancılara karantina uygulanması gibi kısıtlama ve tedbirlerle salgını önlemeye çalışsalar da bu tedbirlerin çok da işe yaradığı söylenemez. Zira alınan tedbirler salgını sona erdirmeyip sadece süreci yavaşlatmaktadır. Salgının bir süre daha devam etmesi halinde ise sonucu en başta fiziksel ve psikolojik olarak insan sağlığını etkileyecek; bununla da sınırlı kalmayıp ekonomi, sanayi, eğitim ve turizm gibi alanlarda telafisi yıllarca mümkün olmayacak zararlara sebebiyet verecektir. 2020 yılı başlarında kısa bir süre içerisinde dünyayı etkisi altına almasına rağmen etkisini uzun süredir devam ettiren COVID-19 salgınını önleyebilmek için şu an elimizde bulunan en etkili ilaç COVID-19 aşılarıdır. Aralık 2020 sonu itibarıyla aşıya erişebilen ülkelerde öncelikli gruplardan başlanmak üzere aşılama başlamıştır. 18 Temmuz 2021 tarihi itibariyle dünya genelinde 3.66 milyar doz aşı yapıldığı görülmektedir. Bazı ülkeler iki doz aşı hedefine ulaşmaya çalışırken ülkemizde de olduğu gibi bazı bölgelerde üçüncü doz aşılamaya geçmişlerdir. Yemen, Mali gibi ülkelerde bu oran oldukça düşükken Haiti gibi bazı gelişmemiş ülkelerde ise henüz tek doz dahi aşı uygulanmamıştır. Koronavirüsün hızlı mutasyon geçiren yapısı göz önünde bulundurulduğunda dünya genelinde eş zamanda aşılama uygulanmadan salgının bitmeyeceği ve sektörler üzerindeki olumsuz etkisini daha yıllarca sürdüreceği ortadadır. Bu nedenle Dünya Ticaret Örgütü ve bazı dünya liderlerinin açıklamalarıyla birlikte COVID-19 aşıları ve tedavileri için ilaç şirketlerinin patent yükümlülüklerinden feragat etmesinin mümkün olup olmayacağı hususunda tartışmalar gündeme gelmiştir. Zira, içinde bulunduğumuz bu olağanüstü dönemde TRIPS Anlaşması kapsamında patent hakkının ilaç şirketlerine sağlamış olduğu yasal koruma ile insanların temel haklarından olan ilaçlara erişim hakkı arasında bir denge kurulması gerekmektedir. Bu çalışmada, COVID-19 aşı ve ilaçlarından patent korumasının kaldırıp kaldırılamayacağı hususu benzer örnekler dikkate alınarak analiz edilecektir.

Keywords

COVID-19 salgını, COVID-19 aşısı, patentin kaldırılması, TRIPS Anlaşması, zorunlu lisanslama

EVALUATION OF PATENT PROTECTION IN PANDEMIC VACCINES AND DRUGS

Abstract

The COVID-19 outbreak was declared a worldwide epidemic (global pandemic) by the World Health Organization (WHO) on March 11, 2020. With this announcement, WHO warned countries that the epidemic represents an unprecedented global economy and health crisis. Although countries try to prevent this pandemic with restrictions and measures such as curfews at various levels, working from home, closing the borders or applying quarantine to foreigners, it cannot be supported that these measures have worked very well due to the measures taken by the countries do not end the epidemic but only slow down the process. If the epidemic continues for a while, the result will affect not only human health, primarily physically and psychologically, but it will also cause damages in various areas such as economy, industry, education and tourism. In order to prevent the COVID-19 epidemic, which has been affecting the world for a short time at the beginning of 2020 but has been continuing for a long time, the most effective remedy we have at the moment is the COVID-19 vaccines. As of the end of December 2020, some countries which can reach shots has begun to vaccinate vulnerable groups. As of July 18, 2021, it is seen that 3.66 billion vaccine doses have been made worldwide.
On the one hand, while some countries are trying to reach two vaccine doses, some other countries have switched to third dose vaccination in some regions, as in our country. On the other hand, even a single dose of vaccine has not been administered in some underdeveloped countries such as Haiti. Considering the rapidly mutating nature of the coronavirus, it is obvious that the pandemic will not end without simultaneous vaccination worldwide. Its negative impact on the sectors will continue for years. For this reason, with the statements of the World Trade Organization and some world leaders, discussions have arisen about whether it will be possible for pharmaceutical companies to waive their patent obligations for COVID-19 vaccines and treatments. Because, in this extraordinary period we are in, a balance needs to be struck between the legal protection provided by the patent right to pharmaceutical companies within the scope of the TRIPS Agreement and the right of access to drugs, which is one of the fundamental rights of people. Therefore, this study will discuss whether a waiver of the pharmaceutical patent obligations for COVID-19 vaccines is possible or not by considering similar examples seen in the world.

Keywords

COVID-19 outbreak, COVID-19 vaccines, waiver of the pharmaceutical patent obligations, TRIPS Agreement, compulsory licencing

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