Intellectual Property, Developing Countries and the Law and Policy of the European Union : Towards Postcolonial Control of Development

The control of knowledge and information in the 21st century is a battleground. The reason is simple: information has become a ‘prime resource’ in modern economic life. The complex ecosystem of information is encapsulated in legal parlance as intellectual property. Characteristically intellectual property regimes create policy restrictions, in the form of exclusive rights to commercial use, on the otherwise free availability of knowledge and information in order to compensate for the cost of production of the knowledge or information. The exclusive rights, in effect, make access a saleable commodity and create the basis of markets for knowledge and technology. While these exclusive rights enable knowledge and technology markets, they also create social tension over the price of access and the lack of access. We have seen this tension played out in relation to access to medicines and biomedical technologies. This thesis attempted to provide the first integrative analysis of how the EU’s rulemaking on intellectual property, both at home and abroad, impacts the ability of developing countries to utilize the flexibilities flowing from the TRIPS Agreement to promote public health and access to medicines. The EU’s intellectual property policy has been conceptualized as comprising two distinct but intertwined normative regimes – the internal and external. The thesis argues that the EU’s internal and external intellectual property policies have developed in manners that are tightly intertwined and detrimental to developing countries’ ability to promote public health and access to medicines. It problematizes the issue in the context of postcolonial theory, supplemented by other theories. This theory underscores the notion that the overly compliant attitude of most developing countries towards international intellectual property laws – despite their obvious effects on their economies – goes beyond contemporary political and economic circumstances. It can be attributed to the colonial roots and neo-colonial structures of this body of law, perpetrated through the EU’s internal and external policy. The development of this law has been complicit in legitimizing the economic control of developing countries at the expense of their development. The overall finding is that the current EU intellectual property policy making approach, both at home and abroad, does not offer the necessary freedom for development in developing countries. It simply works to protect the EU’s industrial interest, with serious implications for public health. This observation is supported by the findings of five individual essays, which recommends, among others, for the EU to streamline its development, industrial and trade policies in ways that could simultaneously meet the development and health care needs of developing countries and the EU’s economic interest. Externally, it recommends that developing countries should not be forced to adopt the kind of laws discussed in this thesis through Free Trade Agreements. If they are, the following measures should be considered: (1) inclusion of a clause on transitional arrangements for developing countries specific to intellectual property in the Free Trade Agreements; (2) inclusion of a mandatory clause that clearly links the objectives for intellectual property protection and enforcement to a balance between the promotion of technological innovation and access to medicines; (3) framing the provisions on public health in the Free Trade Agreements as mandatory requirements or express exceptions, which will stipulate that the implementation of the Free Trade Agreement cannot lead to derogation from the protection of public health; (4) the inclusion of strong and comprehensive sustainable development chapters in the Free Trade Agreements, which are to be effectively implemented and enforced; and (5) allowing for reservations within the meaning of Article 19, Vienna Convention on the Law of Treaties in future Free Trade Agreements. Finally, the concept of substantive equilibrium has been proposed as a means of delinking the EU’s intellectual property policy from post-colonialism.Informaation ja tiedon hallinta on 2000-luvun taistelukenttä. Syy tähän on yksinkertainen: tieto on nykypäivän talouselämän keskeisin resurssi. Tiedon monitahoinen ekosysteemi hahmottuu oikeuden näkökulmasta pitkälti immateriaalioikeuksien kautta. Tyypillisesti immateriaalioikeudet asettavat rajoitteita informaation ja tiedon muutoin vapaalle saatavuudelle määrittelemällä yksinoikeuden kaupalliseen käyttöön korvaukseksi tietämyksen ja tiedon tuottamiseen liittyvistä kuluista. Tosiasiallisesti tällainen yksinoikeus muuttaa käyttöoikeuden myytäväksi hyödykkeeksi ja luo pohjan tietämyksen ja teknologian markkinoille. Sen lisäksi, että yksinoikeudet mahdollistavat tietämyksen ja teknologian markkinat, ne luovat myös sosiaalista jännitettä siihen, millä hinnalla tietämys ja teknologia ovat käytettävissä, jos ylipäätään ovat. Näitä jännitteitä olemme jo nähneet, kun kyse on ollut esimerkiksi lääkkeiden saatavuudesta ja biolääketieteen tekniikoista. Tämän väitöskirjan tavoitteena oli analysoida, miten EU:n immateriaalioikeuksia koskevat määräykset – sekä EU:n sisäisesti että sen ulkosuhteissa – vaikuttavat kehittyvien maiden kykyyn hyödyntää TRIPS-sopimukseen sisältyviä joustomahdollisuuksia kansanterveyden ja lääkkeiden saatavuuden edistämiseksi. EU:n immateriaalioikeuspolitiikka on käsitteellistetty kattamaan kaksi erillistä mutta toisiinsa kietoutuvaa normatiivista menettelytapaa: sisäinen ja ulkoinen politiikka. Väitöskirjassa argumentoidaan, että EU:n sisäinen ja ulkoinen immateriaalioikeuspolitiikka ovat kehittyneet tiiviisti sidoksissa toisiinsa. Ne vaikuttavat haitallisesti kehittyvien maiden kykyyn edistää kansanterveyttä ja parantaa lääkkeiden saatavuutta. Väitöskirjassa problematisoidaan tätä jälkikoloniaalisen teorian ja täydentävien muiden teorioiden valossa. Tässä teoriassa korostetaan, että useimpien kehittyvien maiden kovin alistuvainen suhtautuminen kansainvälisiin immateriaalinormeihin – huolimatta niiden ilmeisistä haitallisistavaikutuksista kyseisten maiden talouteen – nousee vallitsevia poliittisia ja taloudellisia olosuhteita tärkeämmäksi. Syy tähän on löydettävissä näiden normien koloniaalisista juurista ja uuskoloniaalisista rakenteista, jotka heijastuvat EU:n sisäiseen ja ulkoiseen politiikkaan. Kyseisten normien kehitys on osaltaan ollut oikeuttamassa kehittyvien maiden talouden hallitsemista maiden kehityksen kustannuksella. Johtopäätöksenä väitöskirjassa todetaan, että EU:n nykyinen sisäinen ja ulkoinen immateriaalioikeuspolitiikka ei tarjoa riittävää vapautta kehityksen mahdollistamiseksi kehittyvissä maissa. Se yksinkertaisesti suojelee EU:n elinkeinoelämän etuja, millä on vakavia kansanterveydellisiä seurauksia. Havaintoa tukevat viiden eri artikkelin tulokset, joiden pohjalta suositellaan muun muassa, että EU virtaviivaistaisi kehitys-, teollisuus- ja kauppapolitiikkojaan siten, että ne samanaikaisesti täyttäisivät kehittyvien maiden kehitys- ja terveydenhoitotarpeet ja olisivat EU:n taloudellisten etujen mukaisia. EU:n ulkosuhteiden osalta suositellaan, että kehittyviä maita ei pakotettaisi hyväksymään tässä opinnäytetyössä kuvatun kaltaisia normeja vapaakauppasopimusten kautta. Mikäli näin kuitenkin tehdään, seuraavia toimenpiteitä tulisi harkita: (1) kehittyvien maiden siirtymätoimenpiteitä koskevan lausekkeen lisääminen vapaakauppasopimuksiin immateriaalioikeuksien osalta; (2) pakollinen lauseke, jossa selkeästi yhdistetään toisiinsa immateriaalioikeuksien suojelun ja toimeenpanon tavoitteet ja pyrkimys löytää tasapaino teknisen innovoinnin edistämisen ja lääkkeiden saatavuuden välillä; (3) kansanterveyttä koskevien säännösten merkitseminen vapaakauppasopimuksissa pakollisiksi säännöksiksi tai erityisiksi poikkeuksiksi, joissa määrätään, että vapaakauppasopimuksen toteuttaminen ei voi johtaa kansanterveyden turvaamisen huonontumiseen; (4) voimakkaiden ja kokonaisvaltaisten, kestävää kehitystä koskevien lukujen lisääminen vapaakauppasopimuksiin, joita tulee toteuttaa ja toimeenpanna tehokkaasti; ja (5) mahdollisuus valtiosopimusoikeutta koskevan Wienin sopimuksen artiklassa 19 tarkoitettuihin varaumiin tulevissa vapaakauppasopimuksissa. Lopuksi on ehdotettu aineellisoikeudellinen tasapaino -käsitettä keinoksi tehdä selvä ero EU:n immateriaalioikeuspolitiikan ja jälkikolonialismin välille.Siirretty Doriast

Intellectual Property Ordering Beyond Borders

This chapter examines critically the role of technical assistance in the implementation and expansion of intellectual property (IP) norms in Africa, using the protection of plant variety as an illustrative example. It focuses mainly on technical assistance from the World Intellectual Property Organization and the International Union for the Protection of New Varieties of Plants. Relying on Third World Approaches to International Law scholarship and doctrine, it traces the origins of IP technical assistance and its role in the institution of IP norms and protection in Africa. The chapter further discusses the fragmented and complex regime of IP laws in Africa, and finally, the place of technical assistance in the burgeoning plant variety regime on the continent. The central claim is that technical assistance should be seen as a vector of ideas and practices that have progressively led to the systemic integration of African countries into the international IP system (“adherence overdrive”) and the curious case of countries that inadvertently neglect the flexibilities inherent in the IP system when formulating national laws and policy (“compliance overdrive”).</p

Intellectual Property and the Law of Nations, 1860-1920

This chapter examines the unusual extension of Imperial intellectual property laws to British colonies in Sub-Saharan Africa from the late nineteenth century to the early twentieth century, critically appraising how British dominion shaped domestic intellectual property laws and culture, and its impact on the social and economic development of African nations. It argues that contrary to the narrative that there was no apparent imperial strategy as to the development of colonial intellectual property laws, there seems to have been a certain arrangement regarding Africa, which cannot be merely coincidental. Intellectual property laws were imposed on Sub-Saharan Africa, not borrowed, and there must have been a reason for this. Yet unlike other Crown colonies, the Imperial government did not build local capacity nor institutions for intellectual property in Africa. This led to displaced local knowledge governance and innovation systems, and countries ill-equipped to handle the pressures of the twenty-first-century intellectual property system.</p

Inter-parental conflict and outcomes for children in the contexts of poverty and economic stress: implications aimed at improving outcomes for children

This report provides a review of the evidence on discord between parents (interparental conflict) in the contexts of poverty and economic pressure, and the link to poor outcomes for children and adolescents across emotional, behavioural, social, academic and future relationship domains

Revisiting the Question of Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – The Need to Rebalance

The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU free trade agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. I identify the issue as one of “cross-pollination” of laws and argue that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be too technically difficult. However, to the extent that this regime is simulated in developing countries, implementation would damage the health sectors and economies of these countries. I therefore propose that developing countries should not be forced to adopt such laws through FTAs. If they are forced to adopt the laws after all, there should be a compulsory inclusion of (1) a clause on transitional arrangements for developing countries specific to intellectual property; (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balance the promotion of technological innovation with access to medicines; and (3) a clause on Bolar exemption and a manufacturing waiver.</p

MOSAIC Clinical Trial Statistical Analysis Plan Primary Analysis v1.2

The Myopia Outcome Study of Atropine Treatment in Children (MOSAIC) is an investigator-led, double-masked randomised controlled trial of nightly atropine 0.01% eye drops compared to nightly placebo eye drops. A previously published protocol paper outlines the rationale, objective and sample size calculation for the study.1 A total of 250 participants were enrolled in the study and were randomised 2:1 to active treatment and placebo, respectively. This document outlines the plan for analysis of the 24-month outcomes of the MOSAIC

What works to enhance inter-parental relationships and improve outcomes for children

The review summarises the main research evidence on the importance of the relationship between parents to improve outcomes for children. It also reviews evaluation evidence of international interventions designed to improve relationships between parents and provides an assessment of the evidence for UK based programmes

Predictors of underweight in children under-five years in Ghana

Background: Underweight is a key indicator of malnutrition in children and results in long term effects such as abnormalities in physical and mental health, behavioural problems, and low educational achievement.Objective: Using the conceptual framework for child malnutrition by the United Nations Children's Fund, we examined the predictors of underweight in children under five years in Ghana.Methods: This cross-sectional study made use of data from the 2014 Ghana Demographic and Health Survey. A total of 2720 children were included in the analysis. Descriptive and inferential statistics comprising frequency, percentage, chi-square, and binary logistic regression were used in analysing the data.Results: The prevalence of underweight was 11%. Age, wealth status, mother’s education, region, ethnicity, household toilet facility, the source of drinking water, the incidence of diarrhoea, and subscription to health insurance significantly predicted underweight in the children. The risk of being underweight was higher in females than males (OR=1.04, 95% CI=0.81–1.34). This was, however, not statistically significant. The probability of being underweight also declined significantly with mother’s level of education.Conclusion: Our findings underscore the need for the Ghana Health Service and other health sector stakeholders to apportion interventions with a focus on improving complementary feeding, poverty alleviation, and health status of children.Funding: No funding was received for the studyKeywords: malnutrition, underweight, predictors, children, under five, Ghan

Choroidal Thickness Profiles and Associated Factors in Myopic Children

SIGNIFICANCE: This study addresses the lack of choroidal thickness (ChT) profile information available in European children and provides a baseline for further evaluation of longitudinal changes in ChT profiles in myopic children as a potential biomarker for myopia treatment and identifying children at risk of myopic progression. PURPOSE: This study aimed to investigate ChT profiles and associated factors in myopic children. METHODS: Baseline data of 250 myopic children aged 6 to 16 years in the Myopia Outcome Study of Atropine in Children clinical trial were analyzed. Choroidal thickness images were obtained using swept-source optical coherence tomography (DRI-OCT Triton Plus; Topcon Corporation, Tokyo, Japan). The macula was divided into nine Early Treatment of Diabetic Retinopathy Study locations with diameters of 1, 3, and 6 mm corresponding to the central fovea, parafoveal, and perifoveal regions. Multiple linear regression models were used to investigate determinants of ChT. RESULTS: Choroidal thickness varied across themacular Early Treatment of Diabetic Retinopathy Study locations (P \u3c .001): thickest in the perifoveal superior region (mean ± standard deviation, 249.0 ± 60.8 μm) and thinnest in the perifoveal nasal region (155.1 ± 50.3 μm). On average, ChT was greater in all parafoveal (231.8 ± 57.8 μm) compared with perifoveal (218.1 ± 49.1 μm) regions except superiorly where the ChT was greater in the perifoveal region. Longer axial length and higher myopic spherical equivalent refraction were consistently associated with thinner ChT at all locations in the multiple linear regression models. Asian race was significantly associated with thinner ChT only at parafoveal and perifoveal superior regions after Bonferroni correction (P = .004 and P = .001, respectively). CONCLUSIONS: Choroidal thickness was thinnest in the nasal macular region and varied systematically across all macular locations, with axial length and spherical equivalent refraction being the strongest determinants of ChT. Longitudinal evidence will need to evaluate whether any differences in ChT profiles are predictive of myopic progression and to determine the role of ChT measurements in identifying myopic children most in need of myopia control treatment