Experts have raised alarms over emerging changes in the legal framework governing the production, distribution, and export of medicines, as well as timely public access to advanced drugs.

Pakistan is reportedly close to acceding to the Patent Cooperation Treaty (PTC). At the same time, there is a move to require pharmaceutical companies seeking drug registration to obtain prior clearance from the Intellectual Property Organisation, a condition not mandated under the agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), to which Pakistan is a signatory.

“If Pakistan accedes to the Patent Cooperation Treaty and introduces patent linkage prematurely, it could compromise the country’s ability to address its already grave public-health challenges by delaying access to advanced medicines. It would also tilt the playing field in favour of multinational pharmaceutical companies, some of whom may not even have a presence in Pakistan,” noted a senior Islamabad-based source closely tracking the moves and counter moves of key stakeholders.

Pakistani patients deserve not only safe and high‑quality medicines but also timely access to innovative therapies

When asked why the government appears inclined towards options that may not fully align with public interest, key members of the ruling team did not respond before the deadline. The Drug Regulation Authority of Pakistan (Drap) declined to comment on the PTC, stating that the matter falls within the jurisdiction of the ministries of health and commerce. However, it shared a detailed position opposing patent linkage.

Meanwhile, Pharma Bureau, a platform representing multinational, research-based pharmaceutical companies, indirectly supported patent linkage and argued in favour of Pakistan acceding to the PTC.

An insider familiar with these developments said that, in addition to active lobbying by foreign investors, the government has also been nudged by the International Monetary Fund to accede to the PTC.

The issue of patent linkage came into focus after courts ruled that only drugs free from patent protection could be legally registered in Pakistan. The decision was subsequently challenged in the Lahore High Court by three local companies, the Pakistan Pharmaceutical Manufacturers Association and the Drap. The case is yet to conclude.

Amir Lateef, Director Legal, Drap, explained that ‘patent linkage’ refers to the practice of tying a drug’s marketing approval to the patent status of the originator’s product. Under such a system, regulatory approval for a generic medicine cannot be granted before the expiry of the patent unless consented by the patentee. It effectively requires generic manufacturers to prove that the drug for which they seek approval is not protected by a valid patent.

He noted that patent linkage is widely regarded as a TRIPS-Plus mechanism and is not mandated under the actual TRIPS Agreement. Pakistan has also not entered into any bilateral or regional trade agreement that obligates it to adopt such a framework.

Mr Lateef emphasised that Drap’s statutory role is confined to evaluating medicines for safety, quality and efficacy, and granting regulatory approval does not amount to the manufacture, sale, or commercial exploitation of a patented invention. Any dispute regarding patent infringement must be pursued through remedies provided under the Patents Ordinance, 2000, rather than by interfering with the regulatory approval process.

The legislative framework governing pharmaceutical regulation and patent protection in Pakistan, including the Patents Ordinance, 2000 and the Drug Regulatory Authority of Pakistan Act, 2012, clearly maintains a separation between patent enforcement and drug regulatory approval, thereby reflecting the deliberate policy choice of the state not to incorporate a patent linkage regime.

Pakistan’s legal framework, including the Patent Ordinance, 2000 and the Drap Act, 2012, deliberately maintains a separation between patent enforcement and drug regulation. The country also recognises Bolar-like exemptions, which allow generic manufacturers to undertake research, testing and regulatory steps before patent expiry so that generics can enter the market immediately afterwards.

According to Mr Lateef, “Introducing patent linkage could delay the entry of generics and restrict access to affordable medicines, effectively extending patent monopolies beyond the intended intellectual property framework. Drap, therefore, opposes any move to link drug registration with patent status.”

Ayesha T Haq, Executive Director, Pharma Bureau, supported Pakistan’s accession to the PCT, arguing that it would streamline patent filing and strengthen the country’s innovation ecosystem. The PTC allows innovators to submit a single international patent application recognised in 156 member countries, eliminating the need to file separate applications in each jurisdiction. For Pakistani applicants, this offers a more efficient pathway with standardised procedures and wider international patent protection.

“Joining the PCT would signal Pakistan’s commitment to modern intellectual property norms, predictable patent administration, and an innovationfriendly environment that attracts hightechnology and researchdriven investment across all sectors,” she said.

Ms Haq noted that while Pakistan already has a defined patent regime, persistent efforts to dilute existing protections risk undermining it. The Pharma Bureau, part of the Overseas Investors Chamber of Commerce and Industry, has raised these concerns with the relevant ministries.

She maintained that Pakistani patients deserve not only safe and highquality medicines but also timely access to innovative therapies. Weakening patent protection, she argued, could discourage research-based companies from introducing new treatments in Pakistan, potentially reducing the availability of highquality, patentprotected medicines in the market.

Ms Haq declined to comment on the ongoing case on patent linkage but offered, “Linking of the two makes perfect sense. It is more efficient and helps prevent the inadvertent registration of a product that is still under patent protection.”

Pakistan faces a complex public health challenge where infectious diseases persist alongside a rapidly rising burden of non-communicable ones. Limited resources, environmental degradation, and uneven healthcare access worsen outcomes. Urban areas struggle with pollution and overcrowding, while rural communities face severe gaps in medical services.

Published in Dawn, The Business and Finance Weekly, March 16th, 2026