The side-effects of political transition are not likely to subside anytime soon. There is a strong possibility that the fate of the proposed amendment in the Drug Act, 1979 will hang in the balance all this while. The ministry of law, understandably, is preoccupied currently. Probably it will not be able to spare time to vet the document forwarded by the ministry of health before the normalcy is restored.

Over the last week higher ups in Islamabad were too busy to offer comments. First there were farewells and then parting photo shoots with outgoing ministers. However, Dr Fernaz Malik, Drug Controller, ministry of health, confirmed to Dawn on Thursday from Islamabad, that the draft of legislation on data protection had been passed on to the relevant ministry for screening. No one was available in the ministry of law to comment on the progress made so far.

The proposed amendment seeks to induct the data protection clauses in the set of regulations that govern medicine sector. It seeks to allow research drug companies (multinational pharmaceutical companies) a separate period of market exclusivity (monopoly) through data protection. Thus all followers (companies using the formula after the expiry of the patent period) will be required to generate their own set of clinical trial data necessary for registration of a drug that a company intends to introduce in the market.

In Pakistan, like in other developing countries, local firms are followers. They get the raw material and use the freely available information on drugs for production. Later they use the same data when applying for registration by the regulatory authority with a new name under its brand. The drugs they make are ones that have completed their period of patent exclusivity.

The Trade-Related Intellectual Property Rights (TRIPS) Agreement, to which Pakistan is a signatory like all other WTO members, stipulates that undisclosed test data, submitted to the regulator for evaluating safety and efficacy of a drug, should be protected from unfair commercial use. It means that no company will be allowed access to this data for 20 years.

The representative of Pakistan Pharmaceutical Manufacturing Association, (PPMA) a grouping of Pakistani drug makers, saw the piece of the proposed legislation reflective of the clout that the lobby of western multinationals enjoy in Islamabad. They hinted that ex-Prime Minister Shaukat Aziz was particularly warm to this lobby.

The local pharmaceutical manufacturers consider the proposed law in direct clash with the interests of local generic companies.

The pharmaceutical sector has registered phenomenal growth over the last decade and a half. It has grown both in size and depth. Today there are total 664 pharma concerns of which 405 are registered manufacturing units including 31 multinational companies.

The composition of the sector, however, has undergone a change in favour of the local drug industry. It has quietly but steadily grown to claim a sizable share in the local market that is estimated to be of Rs86 billion ($1.4 billion). Today, Pakistani pharmaceuticals enjoy 48 per cent share in the market, up from 25 per cent in early 90s. The rate of growth of local companies at 30 per cent last year has been far above the average national manufacturing growth rate of 8.6 per cent.

”The industry in Pakistan has attained its current status by hard work and sophistication by investing in processes and trained manpower. It has contributed its bit to society by generating employment and enhancing the accessibility of cheaper medicines in the market besides contributing to the exchequer in form of taxes and other levies. We have also made a mark in exports”, said Khalid Mahmood of Getz Pharma.

“If allowed to be implemented in its current form, the proposed amendments in the Drug Act will blunt the edge of generic companies affecting the pace of its growth and hurt the interests of the country by making goals of achieving minimum health coverage for the people more difficult”, he said.

The PPMA has already conveyed its reservations over the circulated draft of the proposed amendments in the Drug Act to the relevant quarters through a detailed letter.

Tahir Iqbal, MD, Merck Sharp and Dohme Pakistan Ltd, (MSD) speaking on behalf of Pharma Bureau (a grouping of pharmaceutical multinational companies) defended the proposed legislation that he felt would ensure availability of quality drugs.

”Besides, being a signatory of TRIPS, it is obligatory on Pakistan to fulfil its commitment towards improving the regulatory framework including provisions relating to data protection in drug trade legislation”, he said.

On the issue of non-existence of such stringent rules in India, Brazil, Argentina and other countries ahead of Pakistan economically, Iqbal gave examples of Egypt and Jordan where, he said, data protection clauses have already been implemented. “India is taking more time but the process has started there as well”, he told Dawn.

Jurgen Konig, MD, CEO Merck, another MNC felt that it is unethical to be a free rider. He said it is not a fair practice of the Pakistani generic firms to use data produced by research pharma at a high cost for getting their products registered.

”It involves a budget of several hundred million dollars and research over a period that is extended at times to more than ten years to develop a new compound after which clinical trials go through different phases. On completion the background scientific data and results of research are handed over to the registration authority in their home country that checks its efficacy and accuracy before patenting it”.

He said: “The process of patenting starts years before a drug is actually launched for marketing that leaves it no more than six or seven years of exclusivity after which its generic production is allowed”.

He said that local companies who wish to enter the pharma market should be ready to make the requisite investment in development of clinical trial data and adhere to other standards necessary for pharmaceutical is a knowledge based sector.

Another MNC supporter who wished anonymity felt that the legislation s necessary to encourage foreign investment. If we value foreign direct investment and wish to persuade big brands to enlarge their operations and enter new fields we will have to create market conditions competitive with other probable investment destinations.

The representatives of local industry roughed up the argument by praying that big research pharma companies get premium returns during their patent period when they have exclusivity rights after which the research and related data becomes public property that can be accessed by whosoever wishes to use it.

They felt that the government needs to ensure the provisions of other ingredients necessary to create conducive investment environment such as dependable infrastructure facilities, law and order as political stability to attract long term investors.

”We must not sidetrack the real issue that is adverse impact of the proposed data protection provision in the Drug Act. Our next door neighbour India has never been overtly kind to pharma majors but it is the most preferred destination of foreign investors in the region”, he said.

Jurgen Konig argued that India and Pakistan are not comparable as situation for pharma industry is different there. “They have a huge local market of some one billion people; they produce a major share of raw material locally; they have a biggest pool of skilled manpower required for the sector; prices there are higher; making it an attractive destination for multinationals”, he said. “Still they must also introduce data protection to which they committed themselves when they signed Trips”, said another MNCs supporter.

The sad fact is that the sickly indicators of public health in Pakistan seem to have a weak link with the robust performance of pharmaceutical industry. As indicated in the current progress report of millennium development goals, the country is behind most health related targets that it set for itself and at the current pace would miss most if not all health related goals by the end of 2015.