111 510 510 libonline@riphah.edu.pk Contact

Law and medicine

The coronavirus is a greater threat to national and global security than terrorism ever was. If we legislated, reinterpreted, and even twisted laws for antiterrorism, we must similarly explore the frontiers of legality in combating this pandemic.

As a developing country, with an already weakened economy, Pakistan is facing a grave threat to its healthcare infrastructure. The dearth of available hospital beds, ventilators, and personal protective equipment (PPE) for healthcare providers is public knowledge. While the government is moving to address these issues in the short-term, a tangible long-term policy remains unaddressed.

The global search for a cure for SARS-CoV-2, the virus strain that causes Covid-19, is well underway. Several existing drugs, originally innovated to treat other ailments, are being trialled for their curative effect on Covid-19 patients. Pakistan must ensure that its medical community has adequate resources to handle the likely number of critical and severe patients. This requires that the government dismantle existing barriers to access for crucial pharmaceuticals.

First, Pakistan must immediately utilize the compulsory licensing provisions in international and domestic intellectual property law. This will allow us to obtain patented drugs and medical equipment at a lower, and perhaps manageable, cost. Second, the state must invoke emergency measures to manufacture and distribute drugs that have shown efficacy in treating acute Covid-19 cases.

Pakistan is not a centre of pharmaceutical innovation. In pharmaceuticals, like with so much else, the global regime has chosen the grant of exclusive licences as the preferred means of kick-starting innovation. In fact, it was with the intention of spreading this orthodoxy that trade and intellectual property protections were tied together when the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement first came into operation in 1996 as part of the WTO regime. However, thereafter, certain expansive provisions were included and clarified to allow developing countries to circumvent the granting of exclusive licenses, particularly in cases of national emergency.

Article 31 of the Trips Agreement allows governments to act “in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use” in such a manner as to make use of the subject matter of a patent without the authorization of the patent holder.

India triggered this exception to patent protection in 2012 for the drug Nexavar, originally developed by the German pharmaceutical company, Bayer AG, for the treatment of liver and kidney cancer. As the patentee, Bayer had complete pricing control and this resulted in Nexavar being sold at a price well beyond the reach of most patients who needed it. India operated under the compulsory licence regime and assigned a licence to an Indian generic manufacturer, who produced its equivalent of Nexavar at a 97pc reduction in price.

A more famous case is of South Africa’s battle to secure the right not only to produce generic versions of antiretrovirals, but also to jump start the process for countries to be able to trade in drugs produced under such compulsory licensing regimes. This has allowed the South African government to fund the treatment of its entire HIV positive population.

A number of states have already started looking to the compulsory licensing regime as a way to ensure the provision of affordable cures for SARS-CoV-2. On March 17, the Chilean parliament passed a unanimous resolution stating that the current pandemic justified the use of compulsory licensing; three days later, Ecuador approved a resolution for issuance of compulsory licenses over patents for coronavirus technologies. These actions of developing countries are particularly necessitated at a time when far richer countries are able to stockpile and dry up reserves of potentially lifesaving pharmaceuticals.

In Pakistan, the Patent Ordinance of 2000 authorizes the federal government to assume or to confer a compulsory license in “the public interest, in particular, national security, nutrition, health” or even to support a “vital section of the national economy.”

While a magic cure is not yet found, the government could deploy such powers towards drugs that have been identified as promising by the WHO. For instance, the WHO has now commented on the promise shown by an experimental drug called Remdesivir, developed by Gilead Sciences Inc, a US company, as an antiviral drug to cure Ebola. The company holds the patents for the drug, both in the US and in several other countries.

Pakistan can follow the precedents on compulsory licensing to procure Remdesivir and other promising patent protected drugs in time and at a cost it can afford. The same rationale can also be used to develop or obtain lifesaving equipment such as respirators.

The DRAP Act 2012 empowers the federal government to enforce the procurement and manufacture of pharmaceuticals and technologies in the public interest. In particular, section 7 (c) (xi) provides for the enforcement of manufacturing; section 7 (c) (vii) enables price setting; and section 7 (g) provides for procurement of foreign expertise in the public interest. The enforcement of manufacturing and pricing can ensure the availability of not only patent protected drugs, but also generic drugs such as hydroxychloroquine sulfate (HCQ), which are already critical for treating malaria, and may prove useful for treating Covid-19.

DRAP and the Competition Commission of Pakistan have the authority to ensure low cost, competitive production of essential medicines and, we would argue, medical equipment. In fact, we could leverage our ability to produce medicines such as HCQ to barter for other essential inputs, as we have reason to believe that the federal government has already begun doing.

Unlike in other places, we have yet to see private industry volunteer to shift production in a manner that addresses the current need. It is therefore incumbent upon the government to act to spur on manufacture as well as combat any hoarding or price gouging.

Pakistan must resolve to act swiftly, decisively, and perhaps not in the most conventional of ways. The WTO, DRAP, and competition laws must be interpreted in the most permissive ways, to allow for both prophylaxis and rapid responses to this evolving threat.

Sadaf Aziz, Uzair Kiyani, Sikander Shah, "Law and medicine," The News. 2020-04-02.
Keywords: Health sciences , Medical equipment , Public interest , Medical community , Global security , National security , National economy , Terrorism