   
  
IP/C/W/666  
 
17 July 2020  
(20-4963) Page: 1/4 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
INTELLECTUAL PROPERT Y AND PUBLIC INTERES T: 
 
BEYOND ACCESS TO MED ICINES AND MEDICAL T ECHNOLOGIES TOWARDS A MORE 
HOLISTIC APPROACH TO  TRIPS FLEXIBILITIES  
COMMUNICATION FROM S OUTH  AFRICA  
1  INTRODUCTION  
1.  A main focus at the WTO has been how to facilitate access to medicines in the context of the 
Doha Declaration on TRIPS and Public Health. The amendment of the TRIPS Agreement entered into 
force in 2017. In the usual way, the term 'TRIPS flexibilities ' has been emphasised in the context of 
access to medicines and medical technology through compulsory licenses or government use and 
even in that context remains under -utilized.  
2.  The High -Level Panel Report on Access to Medicine observes that: "…WTO Members reta ined 
important public health flexibilities that can be used to adapt their intellectual property law, policies 
and practices to meet human rights and public health objectives. These include the ability to 
determine patentability criteria, issue compulsory licences, authorise parallel importation, apply 
general exceptions and employ competition laws to limit and remedy the abuse of intellectual 
property rights in domestic legislation. "1 In this regard, there are still a significant number of 
countries that d o not make full use of available flexibilities under the TRIPS Agreement.  
2  TOWARDS AN INTEGRATE D APPROACH TO TRIPS FLEXIBILITIES  
3.  The use of TRIPS flexibilities to address a public health concern is usually seen as a matter 
concerning patents. However, the COVID -19 pandemic requires a more integrated approach to 
TRIPS flexibilities that include other various types of intellectual property (IP) rights including 
copyrights, industrial designs and trade secrets. The use of TRIPS flexibilities in other areas of 
intellectual property, beyond patents, is less understood at the national level. In fact, in other fields 
of IP, national IP laws may not even provide for sufficient flexibilities to address issues of access. A 
variety of IP rights are relevant in the figh t against COVID -19.  
4.  The COVID -19 crisis created the need to produce essential equipment and medical supplies, there 
is a growing need to be able to manufacture essential medical devices such as masks, ventilators 
and other personal protective equipment. A s the debate over COVID -19 moves beyond medical 
issues, the nature of the pandemic requires non -medical approaches to detect, diagnose and trace 
the coronavirus. Studies have found that levels of neutralizing antibodies against SARS -CoV-2 
remain high for a  few weeks after infection, but then typically begin to wane.2 So far, only one 
infectious disease comparable to COVID -19 in its broad geographic distribution has been eradicated, 
this disease is smallpox.  
5.  According to GAVI, even if eradication of COVID -19 is ultimately technically feasible, it will likely 
be extremely challenging.3 It cautions that given the uncertainty around the technical feasibility of 
 
1 Report of the United Nations Secretary -General 's High -level Panel on Access to Medicines - Promoting 
innovation and access to health technologies (2016) , at p. 22.   
2 Ling Ni, Fang Ye, Meng -Li Cheng et al Detection of SARS -CoV-2-Specific Humoral and Cellular 
Immunity in COVID -19 Convalescent Individuals  Immunity 52, 971–977, June 16 , 2020.  
3 See the GAVI Vaccine Alliance < https://www.gavi.org/vaccineswork/could -covid-19-ever-be-
eradicated >  IP/C/W/666  
 
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  eradicating COVID -19, the global community also needs to plan for the possibility that COVID -19 
will be in global circulation indefinitely. In the absence of prophylaxis through a vaccine and more 
effective treatments, non -medical measures have been an important priority in dealing with the 
devastating impacts of COVID -19. 
6.  Other goods and services that ar e needed to tackle the epidemic include protective equipment 
such as masks, face shields, and hand sanitizers. Such equipment and material remain in critical 
shortage in many countries around the world. Many WTO Members lack domestic manufacturing 
capacity  and would be dependent on imports to meet their medical needs.  
7.  When an exporting country is producing under a compulsory license mainly for export, the 
mechanism established by the 30 August 2003 decision, and later translated into an amendment of 
the TR IPS Agreement as Article 31 bis, would be applicable. This mechanism waives the condition in 
Article 31(f) that a compulsory license should be predominantly for the supply of the domestic 
market. It should be noted that the implementation of the Article 31 bis mechanism at a national 
level is very limited and may not achieve its intended objectives.4 In any event, many developing 
countr y Member s may also face legal, technical and institutional challenges in using TRIPS 
flexibilities. This is especially true f or countries that have never utilized flexibilities such as 
compulsory licenses.  
8.  The World Health Organization has launched the COVID -19 Technology Access Pool (C -TAP) inter 
alia calling on intellectual property holders to voluntarily license such rights on a "non-exclusive and 
global basis to the UNITAID -established and supported Medicines Patent Pool and/or through other 
public health research and development mechanisms, consortia or initiatives that facilitate global 
and transparent access; and/or volun tary non -enforcement of intellectual property rights, as 
appropriate, during the COVID -19 pandemic, to facilitate the widescale production, distribution, sale 
and use of such health technologies throughout the world ". However, to date no company has 
commit ted to doing so. Instead limited, exclusive and often non -transparent voluntary licensing is 
the preferred approached of pharmaceutical companies, which will be insufficient to address the 
needs of the current COVID -19 pandemic.  
3  SOME EXAMPLES  
3.1  Example 1: Bi g data  outside of the health system  
9.  Smartphones, mobile data, artificial intelligence, databases and algorithms have been used in 
the COVID -19 pandemic to leverage the detection and control and control of the virus. Different 
types of IP rights are relevan t to protect AI algorithms, some may be protected by copyright and 
trade secrets while other technology is protected by patents while database rights and trade secrets 
may also be relevant.  
10.  While these approaches help with efforts to contain the spread of the virus, they can raise issues 
about the right to privacy and personal freedoms. National security concerns may also arise in the 
context of Article 73 of the TRIPS Agreement.  
3.2  Example 2: 3D printing technology  
11.  During this COVID -19 outbreak, an Italian hospital ran out of ventilator valves (which cost 
USD 11,000 each) and their regular supplier could not produce them on time. A duo after scanning 
an existing valve, 3D printed replacement valves which only cost about USD 1 each, saving ten lives 
as of the time of the article.  
12.  According to a news report, the original manufacturer was actually approached by the duo in 
hopes to ask for the valve 's blueprints in an urgent attempt to save them time and produce the 
valves to in stantly save the critical COVID -19 victims but they were declined.5 The pair then 
 
4 WIPO CDIP/5/4 Annex II Categories of Different  Provisions o n Specific Flexibilities:  
<https://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4 -annex2.pdf#page=1 > 
5< https://www.techtimes.com/ar ticles/248121/20200317/maker -ventilator -valves -threatens -sue-
volunteers -using -3d-printedcoronavirus.htm > IP/C/W/666  
 
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  proceeded to manufacture the replicas by manually measuring the valves and 3D printing three 
different versions to see which one worked best.  
13.  According to another news repor t, "potential legal and medical issues have stopped Fracassi 
from distributing the digital design file more widely, despite receiving hundreds of requests for the 
3D-printed valves ".6  
14.  Following this case, a law firm warned "…manufacturers should be aware of the complex 
intellectual property issues concerned with this 3D printing technology. Parts such as valves or other 
medical devices and equipment are capable of protection by patent and/or registered design. 
Unregistered design rights and copyright will also apply to the part itself and/or the digital model or 
CAD file. Some or all of these rights might apply in respect of a single component ".7  
15.  The firm cautioned "In scanning a component such as a valve, and manufacturing a part using 
3D printing equipme nt, there is a risk that this action will infringe an existing patent, design or 
copyright which protects the component, leading to an injunction or claim from the rights holder for 
damages or other remedies (such as delivery up of infringing parts) ".8 Furthermore the firm advises 
that any person or company intending to manufacture parts using 3D printing should carry out some 
due diligence to identify:  
• who ultimately holds the intellectual property rights in the component;  
• whether the part is protected by patent or registered design; and  
• whether the rights holder is willing to permit the parts to be manufactured in return for a 
small or nominal royalty for the wider public benefit;  and 
• whether any regulatory approval is needed for supply of the parts.  
16.  This case clearly demonstrates the interface between IP and new technologies such as 3D 
printing and may require a better understand of how a balance may be achieved between rights 
holders and third parties. More collaborative approaches have been achieved thro ugh various pooling 
mechanisms for access to medicines, this is also true for more generic IP pledges that covers a broad 
range of equipment, software, network and device applications useful in healthcare, containment, 
tracking, diagnostics, emergency resp onse and social distancing. Such approaches nonetheless are 
limited and may require action on the side of national authorities to ensure access to such 
technologies where pledges or voluntary licenses cannot be secured on commercially reasonable 
terms.  
3.3  Example 3: Trade Secrets  
17.  Trade secrets encompass vast quantities of information needed to discover, test, create, and 
manufacture diagnostics, treatments, and vaccines.  
18.  Potential trade secrets include manufacturing processes, test data, medical formulas, and  more. 
For vaccines and other biologic medicines, cell lines, genomic information, and other biological 
material can also be held as trade secrets. Data about the effectiveness of medicines and vaccines 
are trade secrets. Even so -called negative informatio n — information about what does not work — 
can be a trade secret.  
19.  Article 39.2 of TRIPS Agreement requires Members to protect undisclosed information which is 
secret, has commercial value and has been subject to reasonable steps to be kept secret. Both 
voluntary and compulsory licenses, though common in other forms of IP are unusual in trade secrets.  
20.  Professor David. S Levine9 posits that: "Clearly, there should be times when trade secrecy 's 
ability to lock down information gives way to broader national and  international information sharing 
concerns. If there were ever a case for re-examining  trade secrecy 's unquestioned dominance, a 
public health crisis on the scale of Covid -19 would be the time. " He concludes by saying: "What 
 
6 <https://www.forbes.com/sites/amyfeldman/2020/03/19/talking -with-the-italian -engineers -who-3d-
printed -respirator -partsfor -hospitals -with-coronavirus -patients -for-free/#1529841378f1 > 
7<[https://www.shoosmiths.co.uk/insights/articles/3d -printing -social -responsibility -vs-legal-risks> 
8 Ibid. 
9 'Covid -19 should spark a re -examination of trade secrets ' stranglehold on information. '  
< https://www.statnews.com/2020/07/10/covid -19-reexamine -trade -secrets -information -stranglehold/ > IP/C/W/666  
 
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  seems initially like a narrow issue involving intellectual property law and innovation may actually be 
a critical barrier to our ability to rapidly, effectively, affordably, and safely solve the Covid -19 
pandemic. The time is now to examine, and re-examine , trade secrecy 's hold on info rmation and 
our collective health. "10 
4  QUESTIONS  
1. To what extent are TRIPS flexibilities embedded in areas outside patent protection well 
understood? If so, how are Members implementing such understandings in their national and 
regional laws?  
 
2. What are the likely difficulties that Members may face in dealing with a changing technology 
landscape where embedded IP rights may affect the dichotomy between IP rights as private rights 
and the public interest dimensions recognised in the TRIPS Agreement?  
 
3. What are the benefits and limitations of initiatives such as voluntary licenses and pledges to 
access much needed technology to deal with the COVID -19 pandemic?  
 
4. Are there circumstances where trade secrets can be shared more broadly? If so, what are those 
circumstances? Would national or international health pandemics fall within this category?  
 
__________  
 
10 Ibid. 