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Chanllenge and Impact after LDC Gradution-11-Oct,21 -Final.pptx

  1. Challenges & Impact in Pharma Sectors After Graduation (2026) from LDC Mohammad Mozammel Hossain Deputy Director Directorate General of Drug Administration
  2. Background ¯^‡ívbœZ †`k n‡Z Dbœqbkxj †`k wnmv‡e DËi‡Yi d‡j evsjv‡`‡ki m¤¢ve P¨v‡jÄ †gvKv‡ijvi Rb¨ cÖ¯ÍwZ, cwiKíbv MÖnb, ev¯Íevqb Zv gwbUwiq msµv‡šÍ cÖavbgš¿xi gyL¨ mwP‡ei †bZ…‡Z¡ MwVZ KwgwUi 13/06/2021 wLªt Zvwi‡Li mfvi wmØvšÍ welqwfwËK wb¤œiæc 6wU Dc-KwgwU MVb Kiv n‡jvt D³ Dc- KwgwU¸wji g‡a¨ 2q Dc-KwgwU n‡jv Sub Committee on Intellectual Property Rights (IPR)– Lead by Secretary, Ministry of Industries Co-Lead: Secretary, Ministry of Commerce. Members: Total Member-09.
  3. As a member of the WTO, Bangladesh has been getting some benefits from the TRIPS Agreement for its LDC status since its inception. These benefits will be no more after graduation from LDC. Hence questions arise what will be the impacts and how Bangladesh will cope. For the accomplishment of said assignments, the TRIPS Agreement should be discussed. As an LDC member, Bangladesh enjoys some benefits from the TRIPS Agreement and simultaneously loses few potential. Introduction
  4. 1. articles 3, 4, and 5. This exemption has been extended till 01 July 2034 recently*. The authority of such extension is the council for TRIPS (article 66.1 of the TRIPS Agreement). 2. LDC countries are also exempted from patent protection for pharmaceutical and agricultural chemical products. (Article 70.8 of TRIPS Agreement ) 3. Because of the LDC countries are exempted from applying the TRIPS Agreement’s provisions other than above exemptions, LDC countries can copy and produce any patented pharmaceutical and agricultural chemical products without getting permission from the inventors. These provisions are helping billions of people from LDC countries to get medicine, fertilizer, and pesticides at cheap affordable prices. Benefits of TRIPS Agreement for LDC countries-
  5.  According to Article 3.1 of the TRIPS Agreement, the treatment of the nationals of other members shall not be less favorable than its nationals of a member.  On the other hand, Article 4 states that if a member grants any advantage, favor, privilege, or immunity to the nationals of any other country regarding intellectual property, it shall accord immediately and unconditionally to the nationals of all other members.  On account of the above provisions, LDC countries cannot grant any patent for pharmaceutical and agricultural chemical invention.  Once any LDC country grants any patent for pharmaceutical and agricultural chemical invention, simultaneously, it has to grant patents to the companies of developed countries and has to take regulatory measures for unauthorized producers of patented products.  For keeping the pharmaceutical and agricultural chemical prices at an affordable level LDC countries have been avoiding granting any patent for those products. Waivers of LDC countries for enjoying benefits of TRIPS-
  6.  Suggest strategy in developing local capacity and prepare to ensure availability of medicine, vaccine, and medical products after graduation. Development of local capacity can be gained by enhancement of investment in Research & Development (R & D). New policy formulation may be required to compel pharmaceutical companies to invest their certain portion of profit to R & D. Remarkable percentage of such investment should be allotted to universities. Universities should introduce institutional IP Policies to increase collaboration with industrial entities for research. Logics/proposals for assigned matters- Cont..
  7. In order to acquire the ability to prepare new medicine i.e. new molecule, placement-based goals and plans have to be adopted in the pharmaceutical industry. A policy may be adopted for government incentives to encourage the development of new drugs, such as the new molecules. Global accredited Drug Testing Laboratories should be establish under the DGDA to ensuring the quality of drugs.
  8.  If the waiver period is over in 2026 the impact on domestic industries and general public health might not be severe. All the common medicines (including antibiotics) are now public domain.  This means the patented period of these medicines has been expired. All patents period expire after twenty years from the filing date (article 33 of the TRIPS Agreement). So no private or sole ownership can not be claimed for the medicine which was patented 20 years back.  Probably only a few medicines for severe diseases like cancer and new diseases like Covid-19 will remain patented after 2026.  However, a study/ survey in this regard is required to find out the complete picture. Whatever findings come in that study will not change the fate of Bangladeshi nationals comparing other nationals of developing countries as they are also buying patented medicines at a higher price. Analyze the impact on domestic industries and general public health, if the waiver period is over in 2026.
  9. If the nationals of other developing countries enduring the higher price of patented medicines, it will not be unbearable for Bangladeshi nationals when they become a citizen of a developing country. ## Intellectual property laws particularly Patent & Design Act 1911 should be complied with the TRIPS Agreement. Traditional knowledge in Bangladesh may be protected. In this regard a new Traditional Knowledge Act may be formulated. Additionally Trade Secret and Integrated Circuit Layout Design Act may be considered to be formulated. Impacts
  10.  The transition periods enjoyed by Bangladesh as LDC to delay the implementation of the TRIPS Agreement have been a defining feature of LDC flexibility in the WTO  The access to manufacture and supply generic medicine  Access to Manufacture API  Manufacturing facilities must have to be compliant by defined regulatory authorities  Earning of foreign revenue by exporting generic drugs  Partnership with international companies  Access to essential life-saving medicines Graduation shall limit
  11. 1. If Waiver of TRIPS Agreement will not be effective up to 1st January 2033 then it will be a challenges for our small and medium size pharmaceuticals and they will be affected. 2. Cost of API will increase many fold due to proprietary rights and at the same time cost of generic drugs will be increased after graduation from LDC category. 3. Cost of the product and API will increase many fold and Affordability of medicine by common people will face difficulties. 4. Export of medicine to many countries will reduce due to proprietary rights or short of competitive biotech drugs like vaccines, biologics, and monoclonal antibodies instead of generic drug. Challenges
  12. 5. In case of antimicrobial resistance to antibiotic is a big challenges in the future if new molecule does not introduced or launched by the world or any country. 6. If our enlisted CRO’s will not fully active in clinical trials for bio-similar or biotech products introduced by the manufacturer then it will create a barrier for introduce new generation molecules. 7. Our respective academic institutions or universities need to develop or establish R&D lab for introduced new molecule or patented drug in the country. 8. We need to develop a facility three-tier direction among Government, academia and industries. 9. Facility to conduct Bio-Equivalance study is must need for Bangladesh Challenges
  13. What other’s are doing after graduation
  14. Constitutional protections for access to medicines It is the policy of the State to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to affordable quality drugs and medicines for all. Example: Philippines & Panama
  15. Using international treaties to promote access to medicines In some countries, the treaty obligations assumed by countries are enforceable through the domestic courts, providing members of the population with a legal pathway for seeking greater access to essential medicines at affordable prices. For example, Argentina’s Constitution refers to a number of human rights treaties which supersede domestic law. Example: Argentina
  16. On public interest grounds, the practice of WTO Members illustrate that national laws may authorize compulsory licenses on a number of additional grounds. For example, Zimbabwe’s Patent Act
  17. Article 31 of the TRIPS Agreement states that in circumstances where the national law of a WTO Member permits a compulsory license to be issued, the Member must first seek permission to use the patent from the patent holder on reasonable commercial terms. However, prior attempts to obtain access to the patented drug on commercial terms are not required in the case of a national emergency (which each Member is free to define), in other circumstances of extreme urgency, or in cases of public, non- commercial use – such as when a government is seeking to ensure universal access to essential drugs or is using the patent for other government purposes Example: “The operation of Article 31 is illustrated by the case of Thailand”
  18. Legislation authorizing the issuing of a compulsory license In order to establish a clear legal basis for exercising the flexibilities that are permitted under the TRIPS Agreement, WTO Member States should enact legislation that sets out the circumstances in which the government reserves the right to issue a compulsory license. Apart from the exceptions mentioned in Article 31(b), such legislation should provide for a reasonable, yet time-limited period for negotiating with the patent holder before the designated national authority issues the license Example: “Industrial Property Law of Brazil”
  19. Strategies we should adopt
  20. Strategies 01 Considering this paradigm shift Bangladesh should update the National lP Policy which was framed during the year 2008 and a National Health Strategy integrating long-term innovation and access objectives through the collaboration between universities, industries and government and public-private partnerships. 02 Registration of New Molecules must have to be facilitated/simplified so that our Pharmaceutical industries can register as many molecules as possible before the graduation. With respect to Article 31, if we register any drug before the originator, the need no compulsory license from originator for that molecule. 03 The Government of Bangladesh may also approach the WIPO, WHO and lP offices of leading developing countries for technical assistance in dealing with TRIPS-compliant patent regime, particularly pharmaceutical patents. 04 Bangladesh can still negotiate for increasing the threshold of LDC graduation or for extending the waiver by creating a new category like 'Newly Graduated Countries in Transition' to achieve SDG on global health and well-being.
  21. Strategies Bangladesh can also bargain for additional transition period during the process and even after being declared formally for some well- founded and duly motivated reasons. Bangladesh may refuse to accept the patent with respect to the 3 (three) reasons that may relate to the Public Health (Article 27.2, Article 27.3A, Article 27.3B of TRIPS agreement) Bangladesh can adopt measures necessary to protect Public Health as per Article 8 & Article 31 of TRIPS agreement Bangladesh should formulate the patent law with respect to future business perspective. 05 06 07 08
  22. 1. We need to add some line in the Patent Act like, “Bangladesh would not grant patent to any product already marketed before graduation to middle-income country.” 2. Bangladesh should provide “process patent” initially, not “product patent”. Bangladesh could use India as an example. India got a transition period until 2005 to fully comply with TRIPS. 3. No secondary patent, no patent term extension. Bangladesh could refer the Section 3d of Indian patent amendment act 2005 where it is stated that “The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable. For the purposes of this clause salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.” Points to be consider during drafting Patent Act
  23. 4. TRIPS safe guards like compulsory licensing, parallel imports, anti-competitive behavior, research exception etc. should be included in the revision of patent law. Also, in case of any emergency or pandemic, Govt. should have the power to decide on whether or not to grant a patent for any particular lifesaving medicine. 5. We need to avoid mailbox provision as it may allow MNC companies to get patent which was filed before the Patent implementation in Bangladesh. Points to be consider during drafting Patent Act:
  24. 1. Bangladesh should increase the number of patent examiners with knowledge of chemistry and pharmacokinetics to ensure that frivolous and ever greening patent claims over existing drugs are rejected in the light of robust patentability criteria to be applied by the patent examiners. 2. Our academic institutions like universities need to gear up their innovation and we need productive academia-industry collaboration for developing new technology and products. Government should implement Research Lab facility in all public university at respective department. 3. For research, clinical trial is a very important area. We need many more CRO who can take care of clinical trials for the Pharma companies who manufacture biological products, monoclonal antibodies, oncological products etc. 4. We have to start giving more focus on API manufacturing. This is very crucial for sustainability of the industry post Patent era. Points to be consider for capacity building on IPR:
  25. 5) After patent implementation, many of the local companies can tie up with patent holder companies to manufacture patented products by acting as Contract Manufacturing Organization (CMO). For this our local industry need to develop expertise in technology transfer process as well as expertise in in-licensing & out licensing legal procedures. 6) Biosimilar Drug, Blood Product, Plasma substitute & Hormone Drug may registered in the country who have the facility to manufacture this drugs before graduation. 7) Simultaneously Clinical Trial should continue with CRO for including High Tech introduced drugs like Biological Products, Monoclonal Antibodies (MABS) & Oncological Products before graduation. 8) Available molecule under patent which may be manufactured by capable industries in the country should be registered immediately. 9) Facility to conduct Bio-Equivalance study is must need for Bangladesh. Points to be consider for capacity building on IPR: