TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

Ograniczenia importu równoległego produktów leczniczych. Uwagi na tle wyroku Trybunału Sprawiedliwości Unii Europejskiej w sprawie C-602/19 Kohlpharma

<p>The judgement in case C-602/19 <em>Kohlpharma</em> is another decision of the Court of Justice of the European Union, which sets legal framework for marketing medicinal products from parallel import. By doing so, the Court continues the adjudicative tradition whereby key aspects of the issue of parallel imports of medicinal products are regulated at the level of EU law through rulings that interpret Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU), issued in specific cases referred to the Court by the referring courts of the Member States. In the commented judgement, the Court upheld the interpretation of Articles 34 and 36 TFEU, according to which these provisions exclude the application of national regulations of a Member State, according to which the withdrawal of a reference authorisation in the importing country automatically results in the expiration of the parallel import licence. The Court also defined more precise limits to the exception contained in Article 36 TFEU concerning the protection of human health and life. This is so because it ruled that the objective of pharmacovigilance may be achieved through actions consisting in the cooperation of the competent authorities of the Member States. The commented judgement is of key importance for the assessment of compliance of Article 21a (3a) of the Polish Act – Pharmaceutical Law with the EU law. In the light of the position of the Court, this provision of the Polish law should be assessed as an excessive restriction on the freedom of movement of goods.</p>

Influence of the Principle of Exhaustion of Exclusive Rights on the State of Competition in Commodity Markets

The article about the discussion on the legal meaning of the principle of exhaustion of the exclusive right to a trademark, including from the point of view of its impact on the state of competition in the commodity markets. The analysis of the legal nature of the principle of exhaustion of the exclusive right to a trademark is carried out, its essential and functional significance is determined. The actual application of this principle has been investigated, including practice of the Russian antimonopoly body in cases of unfair competition on the part of rightholders who prohibit the parallel import of their products. Studied judicial practice on the legality of parallel imports. The problem of the balance of interests of copyright holders, “parallel” importers and consumers is considered, the “pluses” and “minuses” of consolidation in the legislation of the national and regional principles of the exhaustion of the exclusive right to a trademark are assessed.

P650 A trend to higher adoption of mesalazine suppository use for UC patients in 15 European countries

Background In a previous abstract (ECCO 2014), we showed geographical differences between European countries in the use of 5ASA suppositories. The updated ECCO guidelines published in 2016 reiterated the importance of mesalazine suppositories in patients with ulcerative colitis: A mesalamine 1-g suppository once daily is the preferred initial treatment for mild or moderately active proctitis, mesalamine foam or enemas are an alternative, but suppositories deliver the drug more effectively to the rectum and are better tolerated [Statement 11A]. We wanted to look at the changes in mesalazine suppositories use and compare it to 2012. Methods We collected the data of suppositories consumption from April 2019 until March 2020 from IMS, the prevalence of UC in 2019 from the Global Health Data Exchange and the estimation of the population for 15 European countries (Czech Republic, Denmark, Estonia, Finland, France, Greece, Germany, Ireland, Latvia, Lithuania, Norway, Portugal, Spain, Sweden and the United Kingdom) from the Eurostat database. For comparison purposes, we assumed that all the patients could receive a 1000 mg daily dose of mesalazine suppository. Results The aggregate sales data from IMS show that 26979 kg of mesalazine suppository were consumed during the full year in 15 European countries. If we exclude Spain from the analysis, 23096 kg were consumed by 14 countries and this is a 1.6-fold increase in comparison to 2012. Assuming a cut-off of 33% of UC patients receiving the maximum daily dose of 1000 mg, 4 countries showed high use of mesalazine suppositories above that cut off: Greece, Ireland, Spain and Portugal. Except for Ireland, those 3 other countries are from Southern Europe. In addition when we compare the data from 2019 to 2012, we see a clear increase in the use of mesalazine suppository in the 14 countries. All countries showed an increase in suppository use that is above 50% except for Czech Republic, Denmark, France and Sweden. The increase in those countries was less pronounced. Sweden and Norway had the lowest rate of suppository use compared to the other countries. Conclusion Despite all the uncertainty around the UC prevalence and parallel import (due to price difference between the different European countries), there is a clear trend toward a higher use of suppositories in all the European countries. A full analysis of the topical use of mesalazine (suppository, foam and enema) would be interesting to evaluate more accurately the adherence to the ECCO guidelines in clinical practice.

Global trade and health: an Indonesian perspective on the asean medical device directive policy

Purpose: Health care equipment international trade could serve a new strategic revenue for Indonesia. Since its implementation in 2015, AFTA has been a very strategic issue in creating export opportunities for its member countries. One of the sectors that becomes a priority for ASEAN integration is in the field of medical devices which is regulated in the ASEAN Medical Device Directive (AMDD) policy. Indonesia itself has officially ratified AMDD policy since 2018, but Indonesia will have been facing the problem of quality, innovation and diversification of medical devices. This study examines the competitiveness opportunities for domestic medical devices in ASEAN Free Trade Area. Method: This study used a qualitative method where information was obtained from in-depth interviews and document review. The informants came from policy makers, implementing officers, and stakeholders. Results: Indonesia has harmonized 26 out of 31 standards mandated by AMDD. Conformity assessment bodies in Indonesia that have been certified by the National Accreditation Committee have received international recognition. Indonesia has many potential exporting innovative medical devices to ASEAN countries. Fulfillment of medical devices is carried out through compulsory licensing and parallel import mechanism.

The Exclusive Rights of Licensees in Parallel Import Practices

Parallel imports are one of the most interesting and unique phenomena of international trade. On one hand, it applies competition law, while on the other, trademark law and the customs law also apply in this activity. Parallel imports occur when genuine goods are imported in parallel (concurrently) to goods imported by a licensee. These parallel imports are then sold at a cheaper price than that of the goods of the licensee. This parallel import activity is inconsistent with the exclusive rights that the licensee receives under the licensing agreement it makes with the owner of the trademark. This exclusive right is essentially monopolistic, entitling the licensee to prevent all parties with the commercial intention of selling the same or similar goods as their own. However, the right to monopoly is limited for the sake of a fair competition. The licensee can sue to get compensation in parallel importation base on unjust enrichment principle. Moreover, parallel importation can be inhabited by enforcing procedural and administration regarding import of goods such as, Indonesian national standard and label in bahasa

South African experience in regulating parallel import of medicines

The article provides an overview of the South African experience in the use and adaptation of parallel imports of medicines, as well as the prospects for the implantation of parallel imports in Russia. The main factors, the economic aspects and legal grounds for the introduction and regulation of parallel imports in South Africa are analyzed. The article provides an assessment of the impact of parallel imports on the formation of prices for pharmaceutical products. The introduction of parallel imports in African countries led to a significant decrease in the prices for pharmaceutical products, which led to a positive trend in the pricing of medicines in national economies, which have significantly lower GDP per capita compared to developed countries. Despite this positive trend, there are still a lot of questions regarding the consequences of the introduction of parallel imports in developed and developing countries, which requires studying the achievements of those nations that obtained considerable expertise in this area.

Specific features of intellectual property rights protection under the crossing of customs border of Ukraine by goods

The paper investigates the problems of protecting intellectual property rights when goods crossing the customs border of Ukraine. The necessity of reforming the national system for the protection of intellectual property rights and bringing it into line with international legislation has been proved. The proposed projects of changes in domestic legislation, contributing to the implementation of the EU mechanisms for the protection of intellectual property rights at customs, and will allow to strengthen the fight against counterfeit and pirated products during their movement across the customs border of Ukraine are considered. Analyzed the main normative legal acts on the research problem, and developed a methodology for customs control and customs clearance of goods containing intellectual property. The paper describes the most common violations in the field of intellectual property rights, among the main authors highlighted the problems of parallel import and patent trolling. It is noted that an important step towards the protection of intellectual property rights was the creation of an appropriate customs register of objects of intellectual property rights as part of the Unified Automated System of the State Customs Service. The specified system includes the established procedure for online registration of the corresponding objects of intellectual property rights, which makes it possible to reduce the time for consideration of applications and their placement. It is indicated that the protection of intellectual property rights provides for an increase in the level of prevention and counteraction to the movement across the customs border of Ukraine of goods that violate such rights, and helps to cleanse the domestic market from counterfeit products. Today, a new Customs Register of Intellectual Property Objects is being formed and a center for operational expertise is being created.