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The purpose of this study is to highlight the absence of specific provisions on public health under Article 31bis of the TRIPS Agreement, that were not incorporated into the Patents Act 1983 in Malaysia. The main research question of this study is; why should Malaysia immediately amend its Patents Act 1983 to incorporate these flexibilities? Malaysia must develop effective strategies to implement policies, law and governance in managing the country's public health system. This is to ensure a balance of rights between intellectual property owners and the public, at all times. This study employs a qualitative research methodology that is based on primary sources such as the TRIPS Agreement and the Patents Act 1983, and is further supported by secondary sources such as journals and the contents of authorities' websites. This study is limited to the issues related to public health and patents. This study includes a discussion on the provisions related to patents and public health, proposed amendments to the Patents Act 1983 that should incorporate the provisions from Article 31bis, and a conclusion on the importance of immediately amending the Patent Act 1983 to incorporate these provisions, especially during the current Covid-19 pandemic. This study proposes that the amendments be made to Section 84 of the Patents Act 1983 in relation to Rights of Government, and not through the compulsory licence mechanism under Part X of the Patents Act 1983. Thus, this study concludes that currently, Malaysia is unable to implement the provisions under Article 31bis, unless the Patents Act 1983 is amended.

In this article, the author analyzes the effectiveness of the Compliance Programs, as a condition to exempt the legal entity from criminal liability, in view of article 31 bis of the Spanish Penal Code. In this line, it approaches the content of the term from a focus on prevention and management of criminal risk, in light of the elements and quality criteria proposed by comparative legislation and international standards of compliance and good corporate governance. ; En el presente artículo la autora analiza la eficacia de los Programas de Compliance, como condición para eximir de responsabilidad penal a la persona jurídica, de cara al artículo 31 bis del Código Penal español. En esa línea, realiza un acercamiento al contenido del término desde un enfoque de prevención y gestión del riesgo penal, a la luz de los elementos y criterios de calidad propuestos desde la legislación comparada y de los estándares internacionales de cumplimiento normativo y buen gobierno corporativo.

Global justice theorists have widely discussed how the international intellectual property rights regime (i.e., the TRIPs regime of the World Trade Organization) makes it more difficult to achieve the goal of universal access to generic (and more affordable) vital COVID-19 treatments (including potential COVID-19 vaccines). This article argues that while patents can impose certain barriers to universal access to generic COVID-19 treatments, the TRIPs regime itself is an integral part of an equitable global solution to the pandemic. More specifically, it argues that article 31bis of the TRIPs, in allowing for a cooperation strategy predicated on complementary importing and exporting of vital COVID-19 generic treatments, is key for successful pandemic suppression. By providing a normative interpretative analysis of article 31bis in light of the ethical requirements of global justice, and by responding to possible objections to its core argument, this article substantiates the ideal of multilateral solidarity among nations. In times of crisis—not only a crisis of global public health, but also a crisis of multilateralism—this complementary cooperation strategy that article 31bis allows for shows a way forward in upholding the global common good that the international legal order seeks to safeguard.

This entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified 'free riding.' Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address the priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against the restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a 'net benefit' for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in production and distribution of medicines. The authors doubt that the international political environment would support renegotiation of an 'improved' solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale.

AbstractThis article is a critical legal analysis of the proposed TRIPS waiver under World Trade Organization (WTO) law. It reviews the existing TRIPS flexibilities and the "August 2003 TRIPS waiver", highlighting the obstacles to achieving the goals of these legal instruments. It demonstrates that numerous critical TRIPS flexibilities, notably TRIPS Article 31bis, are ineffective, prompting some countries to submit a new waiver proposal to the WTO. It highlights several WTO rules that are also quite ambiguous. This paper argues that a WTO clarification might be an alternative to the new TRIPS waiver proposal if it is ultimately rejected due to a lack of consensus among WTO members. Finally, this article emphasises the importance of adopting a balanced approach that may simplify complicated TRIPS rules, decrease the risk of trade-based retaliation and improve collaboration in knowledge transfer and scaling up the manufacture of and access to lifesaving vaccines, pharmaceuticals and healthcare equipment.

ABSTRACT
The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that may be achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment of Regional Pharmaceutical Supply Centers (RPSCs) for the collective procurement of products, and the need to coordinate the issuance of necessary compulsory licenses for production and/or importation, depending on relevant circumstances. The authors envisage that centralized coordination by RPSCs should assist in overcoming difficulties individual countries may encounter in addressing administrative and technical issues in procuring supplies, as well as creating improved bargaining leverage with potential suppliers. The authors finally address the problem created by the decision of various high-income countries to 'opt out' as eligible importing countries under the World Trade Organization TRIPS Agreement Article 31bis amendment that addresses the predominant export of pharmaceutical products under compulsory licenses.

In December 2005, the WTO responded to the HIV/AIDS pharmaceutical crisis in the least developed world by voting to make the first permanent amendment to the WTO Agreements since their original negotiation during the Uruguay Round. New Article 31bis will amend the TRIPS Agreement to permit compulsory manufacturing licenses in order to facilitate supply of needed pharmaceuticals to those countries lacking the technological capacity to produce these drugs themselves. The amendment reflects a substantial shift in the essential TRIPS bargain, constituting a significant give-back to those developing countries that specialize in the generic production of pharmaceuticals. To date, however, there has been no significant utilization of this facility (which was provisionally established in August 2003). Rather, patent holders have determined - perhaps under the threat of these newly authorized compulsory licenses - to supply these markets directly with HIV/AIDS drugs at prices much lower than those prevailing in developed country markets. As a condition of doing so, both the pharmaceutical industry and those WTO members that champion their interests have sought and obtained limitations on the parallel trade of drugs subject to differential pricing. This shift away from TRIPS' prior neutrality on parallel trade may well spill-over into additional areas beyond the particular context in which the amendment developed. We make the following observations: 1. TRIPS was previously neutral on the permissibility of parallel trade. Until now, WTO members were free to either permit or prohibit the import and sale of intellectual property ("IP")-covered goods that had been placed into commerce in foreign markets. That is, IP-right holders may or may not be provided with an ancillary right to block the importation and sale of grey-market goods. 2. Parallel trade has not been a solution to assuring the supply of needed drugs to AIDS-stricken regions of the least developed world. Quite simply, there has not been an adequate source-of-supply at prices that the afflicted Least Developed Countries (LDCs) are capable of paying. 3. Compulsory licensing now has a clear legal basis as a result of the TRIPS amendment (and the provisional rule in place since August 2003), yet virtually no countries have resorted to compulsory licensing. 4. HIV/AIDS drug prices in LDC markets have fallen significantly, which suggests that pharmaceutical manufacturers have determined to supply LDC markets directly, instead of permitting LDC demand to be met by generic producers utilizing the amended TRIPS rules on compulsory licensing. Their determination to do so may have been motivated, at least in part, by the threat of compulsory licenses. 5. Both the WTO community and the pharmaceutical industry have embraced a policy of differential prices: high prices in developed markets and dramatically lower prices in LDC markets. There has also been significant differentiation in products supplied. 6. Effective controls on parallel trade are necessary to attain effective differential pricing. Without limits, low-priced drugs supplied to LDC markets would flow back, by operation of arbitrageurs, into high priced markets. This would undercut the economic returns in the high priced markets and starve LDCs of their supply. Thus, at least within the drug sector, TRIPS formal neutrality as applied to parallel trade cannot stand. 7. The European Union and the United States have non-IP restrictions that sharply reduce the likelihood of parallel trade in pharmaceuticals. The observed positional shift in TRIPS from neutrality on parallel trade to opposition may well spill-over from the HIV/AIDS pharmaceuticals context into a larger rethinking of the appropriateness of IP-holders engaging in price discrimination.

I would like to thank dr hab. Marek Świerczyński prof. UKSW for his comments and suggestions, which helped me considerably to improve the article. ; A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, first of all towards the re-granting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder). ; This article was written based on the performance of the scientific research project no. 2017/25/N/HS5/01505 named: Legal model of biosimilars, financed by National Scientific Center. ; z.wieckowski@uksw.edu.pl ; Assistant at Law and Administration Faculty on the Cardinal Stephan Wyszynski University in Warsaw. ; Cardinal Stephan Wyszynski University in Warsaw, Poland, Law and Administration Faculty ; Bashaar, M., Hassali, M. A., & Saleem, F. (2017). 40th anniversary of essential medicines: a loud call for improving its access, GaBI Journal, 6(4), 174-177. ; Beyer, P. (2013). 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