This blog post was co-authored with Ana Santos Rutschman
The scarcity of life-saving medicines frequently slows government response to public health emergencies. During the COVID-19 pandemic, many countries were unable to obtain sufficient quantities of COVID-19 vaccines, remdesivir, and newer antiviral treatments. This problem is not new: similar problems occurred during the recent Ebola and H1N1 (swine flu) outbreaks. Nevertheless, when COVID-19 arose, the world was no better equipped to prevent scarcity.
Intellectual property (IP) rights, such as patents and trade secrets, contribute to this problem. On one hand, IP rights encourage pharma companies to invest in developing new drugs. Drug development and clinical trials are extremely expensive, requiring the investment billions of dollars for a drug that may never make it to market. IP rights ensures that pharma companies are incentivized by allowing them to recoup their investments.
On the other hand, IP rights slow down governmental response to scarcity. Under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS), World Trade Organization member countries are required to protect IP rights. This includes offering pharmaceutical-related patent protection and allowing companies to protect manufacturing processes as trade secrets. TRIPS does contain some safeguards for times of emergency. For example, it allows countries to utilize compulsory licensing, in which a government grants a third party a license to patented technology without the patent holder’s permission. However, there is no mechanism under TRIPS to compel companies to share the details for how to successfully recreate and effectively manufacture their technology. Nor do such provisions exist in national laws for high-income countries like the United States. This means that for complex products such as vaccines, it can take years to recreate the drug and then gain regulatory approval. During a public health crisis like COVID-19, such delays mean a greater disease burden and more deaths.
This problem is illustrated by Moderna’s mRNA vaccine, which it developed with $2.5 billion in public funding. Under U.S. law, the government may license Moderna’s patented vaccine to a third-party manufacturer without Moderna’s permission. However, without Moderna’s cooperation, it would take a third party many months to recreate the vaccine, because the tiniest changes in manufacturing conditions can have a dramatic impact on vaccine efficacy and safety. Moreover, third-party manufacturers may face logistical hurdles in accessing the raw materials needed to produce the vaccine. Even if Moderna’s vaccine were successfully replicated, the third-party producer would have to prove that its version is safe to gain approval from the U.S. Food & Drug Administration. A legal mechanism to compel companies like Moderna to cooperate with third-party manufacturers would be far more efficient.
We believe that governments that provide funding for pharmaceutical-related research possess an important tool that they can leverage: the terms of their contracts that provide the funds. Many drugs that are brought to market are derived from government-funded research. When offering drug development funding, governments could use contractual provisions obligating the recipient to address scarcity of medicines. This could work at two different levels.
First, governments that provide funding for pandemic-specific pharmaceutical research could add safeguards to prevent or alleviate scarcity. Pharma companies that accept such funds would agree that subsequently-developed medicines would be made available to the public in sufficient quantity. In the event of scarcity, a grace period would begin to give the company time to address the problem. Afterwards, the company would be required to share technology with third-party drug manufacturers until there is a sufficient supply, or for the duration of the public health crisis, whichever occurs first. The government would, in exchange, pay pre-determined compensation to the company. Any company subject to such an agreement that refuses to cooperate would face financial penalties under the contract.
Requiring this up-front commitment from pharma companies would offer several benefits. It would prevent delays in negotiating with the producer and allow third-party drug manufacturers to gain access to know-how that is needed to scale up production quickly. Moreover, the mere threat of triggering the provision may prompt companies to voluntarily license out their technology. Currently, such out-licensing tends to benefit only a subset of countries. For example, in 2020, Gilead Sciences voluntarily licensed production of remdesivir to several foreign manufacturers. However, the resulting medicine could only be used by citizens in low-income and a few middle-income countries, even though high-income countries were also impacted by shortages.
Second, governments could proactively deploy dormant licenses to promote access to medicines. Such a license would be made up of a set of contractual provisions, that impose certain requirements on funding recipients and take effect if and when an agreed-upon event occurs. In this case, the triggering event would be a pandemic or epidemic. To improve legal certainty, we suggest that the trigger should be a formal declaration by a trusted body, such as a pandemic declaration issued by the World Health Organization.
The obligations imposed by the dormant license may vary according to the government’s goals. Under an optimal approach, the license should mandate the timely transfer or commercialization of technologies covered by the license and establish affordable pricing of the resulting medicines. Where applicable, the license could also include an obligation to allocate medicines according to public health needs rather than to highest or first bidders. For example, in the case of pandemic vaccines, the agreement could commit a set percentage of doses to international procurement structures such as COVAX. It would be up to the individual government to decide how to tailor the dormant license.
Taken together, our proposals would create a legal framework to improve access to much-needed medicines during pandemics and epidemics. It could be utilized alone or in combination with other proposals to help ensure that when the next pandemic arises, we will be better prepared.
Ana Santos-Ruchman, mwandishi wa jarida la The Guardian, alisema kuwa upungufu wa dawa za kuokoa maisha mara nyingi hupunguza mwitikio wa serikali kwa dharura za afya ya umma. Wakati wa janga la COVID-19, nchi nyingi hazikuweza kupata kiasi cha kutosha cha chanjo za COVID-19, remdesivir, na matibabu mapya ya antiviral. Matatizo hayo yametokea mara kadhaa katika kipindi cha maambukizi ya Ebola na H1N1 (mwitu wa nguruwe). Hata hivyo, wakati COVID-19 ilipotokea, ulimwengu haukuwa na vifaa bora vya kuzuia upungufu. Haki za mali ya akili (IP), kama vile hati miliki na siri za kibiashara, zinachangia tatizo hili. Kwa upande mmoja, haki za miliki huchochea makampuni ya dawa kuwekeza katika kutengeneza dawa mpya. Majaribio ya kliniki na maendeleo ya dawa ni gharama kubwa sana, na inahitaji uwekezaji wa mabilioni ya dola kwa dawa ambayo inaweza kamwe kufanya hivyo kwa soko. Haki za IP zinahakikisha kwamba makampuni ya dawa yanachochewa kwa kuruhusu wao kupata uwekezaji wao. Kwa upande mwingine, haki za miliki hupunguza mwitikio wa serikali kwa upungufu. Mkataba wa TRIPS (Uhusiano wa Biashara na Mambo ya Haki za Maliasili) unawajibika nchi wanachama wa Shirika la Biashara Duniani kulinda haki za maliasili. Hii ni pamoja na kutoa ulinzi wa hati miliki zinazohusiana na dawa na kuruhusu makampuni kulinda michakato ya utengenezaji kama siri za kibiashara. TRIPS ina baadhi ya ulinzi kwa ajili ya nyakati za dharura. Kwa mfano, inaruhusu nchi kutumia leseni ya kulazimishwa, ambayo serikali inatoa chama cha tatu leseni ya teknolojia ya hati miliki bila ruhusa ya mmiliki wa hati miliki. Hata hivyo, hakuna utaratibu chini ya TRIPS kulazimisha makampuni kushiriki maelezo ya jinsi ya kufanikiwa recreate na ufanisi utengenezaji wa teknolojia yao. Wala hakuna masharti kama hayo katika sheria za kitaifa kwa nchi zenye mapato ya juu kama vile Marekani. Hii inamaanisha kwamba kwa bidhaa ngumu kama vile chanjo, inaweza kuchukua miaka kuunda tena dawa na kisha kupata idhini ya udhibiti. Wakati wa mgogoro wa afya ya umma kama COVID-19, ucheleweshaji kama huo unamaanisha mzigo mkubwa wa ugonjwa na vifo zaidi. Moderna imetoa chanjo ya mRNA kwa dola bilioni 2.5 kwa ajili ya utafiti huo. Kulingana na sheria ya Marekani, serikali inaweza kutoa leseni ya chanjo ya Moderna kwa mtengenezaji wa tatu bila ruhusa ya Moderna. Hata hivyo, bila ushirikiano wa Moderna, ingechukua mtu wa tatu miezi mingi kuunda chanjo, kwa sababu mabadiliko madogo zaidi katika hali za utengenezaji yanaweza kuwa na athari kubwa kwa ufanisi na usalama wa chanjo. Kwa kuongezea, wazalishaji wa tatu wanaweza kukabiliwa na vizuizi vya vifaa katika kupata malighafi zinazohitajika kutengeneza chanjo. Hata kama chanjo ya Moderna ingefanikiwa kuiga, mtengenezaji wa chama cha tatu angehitaji kuthibitisha kwamba toleo lake ni salama kupata idhini kutoka kwa Utawala wa Chakula na Dawa wa Marekani. Utaratibu wa kisheria wa kulazimisha makampuni kama Moderna kushirikiana na wazalishaji wa chama cha tatu ungekuwa na ufanisi zaidi. """Tunaamini kwamba serikali zinazotoa fedha kwa ajili ya utafiti unaohusiana na dawa zina chombo muhimu ambacho wanaweza kutumia: masharti ya mikataba yao ambayo hutoa fedha." Dawa nyingi zinazoletwa sokoni hutokana na utafiti unaofadhiliwa na serikali. Wakati wa kutoa fedha za maendeleo ya dawa, serikali zinaweza kutumia masharti ya mkataba yanayomlazimisha mpokeaji kushughulikia upungufu wa dawa. Hii inaweza kufanya kazi katika ngazi mbili tofauti. Serikali zinazotoa fedha kwa ajili ya utafiti wa dawa za kuambukiza virusi vya corona zinaweza kuongeza ulinzi ili kuzuia au kupunguza upungufu. Kampuni za dawa zinazokubali fedha hizo zitaruhusu dawa zilizotengenezwa baadaye zipatikane kwa umma kwa wingi wa kutosha. Katika hali ya upungufu, kipindi cha msamaha kingeanza kutoa kampuni wakati wa kushughulikia tatizo hilo. Baada ya hapo, kampuni hiyo itahitajika kushiriki teknolojia na wazalishaji wa dawa wa tatu hadi utoaji wa kutosha au kwa muda wa mgogoro wa afya ya umma, ambayo hutokea kwanza. Serikali, kwa kubadilishana, ingelipa fidia iliyowekwa kimbele kwa kampuni hiyo. Kampuni yoyote inayohusika na makubaliano kama hayo ambayo inakataa kushirikiana ingekabiliwa na adhabu za kifedha chini ya mkataba. Kuhitaji ahadi hii ya awali kutoka kwa makampuni ya dawa kungetoa faida kadhaa. Hii itazuia ucheleweshaji katika mazungumzo na mtayarishaji na kuruhusu wazalishaji wa dawa wa tatu kupata ujuzi unaohitajika ili kuongeza uzalishaji haraka. Zaidi ya hayo, tishio tu la kuamsha utoaji huo linaweza kuchochea makampuni kutoa leseni ya teknolojia yao kwa hiari. Kwa sasa, utoaji wa leseni kama hiyo hufaidi tu sehemu ndogo ya nchi. Kwa mfano, Gilead Sciences ilitoa leseni ya uzalishaji wa remdesivir kwa wazalishaji kadhaa wa kigeni. Hata hivyo, dawa hiyo inaweza kutumika tu na wananchi katika nchi zenye mapato ya chini na nchi chache zenye mapato ya kati, ingawa nchi zenye mapato ya juu pia zilichanganyikiwa na upungufu. Pili, serikali zinaweza kutumia leseni zisizotumika ili kukuza upatikanaji wa dawa. Leseni kama hiyo itaundwa na seti ya masharti ya mkataba, ambayo huweka mahitaji fulani kwa wapokeaji wa ufadhili na huanza kutumika ikiwa na wakati tukio lililokubaliwa linatokea. Katika kisa hiki, tukio linalochochea lingekuwa janga au janga. Ili kuboresha uhakika wa kisheria, tunapendekeza kwamba kichocheo kinapaswa kuwa tangazo rasmi na chombo cha kuaminika, kama vile tangazo la janga lililotolewa na Shirika la Afya Ulimwenguni. Wajibu uliowekwa na leseni ya kulala inaweza kutofautiana kulingana na malengo ya serikali. Chini ya mbinu bora, leseni inapaswa kuamuru uhamisho wa wakati wa teknolojia zinazofunikwa na leseni na kuanzisha bei ya bei ya dawa zinazotokana. Ikiwa inatumika, leseni inaweza pia kujumuisha wajibu wa kugawa dawa kulingana na mahitaji ya afya ya umma badala ya kwa wauzaji wa juu au wa kwanza. Kwa mfano, katika kesi ya chanjo za janga, makubaliano yanaweza kujitolea asilimia fulani ya dozi kwa miundo ya ununuzi wa kimataifa kama vile COVAX. Ingekuwa juu ya serikali ya mtu binafsi kuamua jinsi ya kurekebisha leseni ya kulala. Kwa pamoja, mapendekezo yetu yatatengeneza mfumo wa kisheria wa kuboresha upatikanaji wa dawa zinazohitajika sana wakati wa janga na janga. "Inaweza kutumika peke yake au kwa mchanganyiko na mapendekezo mengine kusaidia kuhakikisha kwamba wakati janga linalofuata litakapotokea, tutakuwa tayari zaidi. """