Multi-national Companies (MNCs) have an objective of increasing investment in Pakistan, in improving its economy and act as ambassadors to attract FDI, but stressed that a continued weak IPR environment was not a positive message to investors.
Major IPR issues included the availability of counterfeits, Patents infringements, slow progress on mail-box applications and the absence of Data Exclusivity Law as per TRIPS Article 39.3.
He stated that counterfeit medicines posed health and safety risk to consumers and severe penalties should be included in the laws against violators as present penalties were meagre. He showed report of a survey that was published in British Medical Journal, a medical journal of esteem repute, in February 2004 that stated that nearly 40-50 percent of medicines available in the market in Nigeria and Pakistan were counterfeits.
Setting up a special IPR Investigation Force for quick investigation and establishment of special IPR Tribunals for speedy trials were recommended. Patent Ordinance 2000 should be restored as the present Amendments 2002 is not TRIPS compliant and should therefore be repealed.
Citing examples of copies that have been registered in violation of patent rights, he emphasised Patent linkage needs to be incorporated in the Drugs Act 1976 to ensure that registration of copies of patent products do not result in patent infringements, and rights of the patent owner are upheld. He reinforced that the rights of the patent holder should be honoured by Ministry of Health at the time of registration of copies, as patent rights were granted by the Government of Pakistan.
The process of granting of patents related to Mail Box application also needs to be expedited as till now only 20 patents have been granted and of these only one is a product patent.
There should be a Law on Data Exclusivity (DE) as per TRIPS Article 39.3. In the absence of a DE Law, local manufacturers were using the scientific data of Originals while submitting registration applications of their copies with Ministry of Health (MOH) and MOH was relying on this data in granting registration to copies.
It takes nearly 15 years to bring a molecule to the market as a drug, at a cost of over 1.4 billion US dollars, and nearly 41 percent of this amount was due to expenses incurred in conducting extensive safety and efficacy studies. WHO did not require extensive studies on generics provided validated Bioequivalence data was submitted in comparison to Original.
In Pakistan, where Bioequivalence studies are not done, it was therefore inappropriate on part of Ministry of Health to consider copies being equivalent in quality to Originals simply on the basis of common molecules.
A major question that arose was, in the absence of Bioequivalence studies and considering that it is not appropriate for local manufacturers to use the scientific data of Originals', what kind of safety and efficacy data should they be submitting to MOH at the time of registration of their products?
There was a dire need for capacity building on IP and it is through awareness that misconceptions can be removed. Contrary to the belief that a IP regime, including DE, would highly restrict the development of the local industry, it was shown that the largest flourishing generic market in the world is in USA, where strict IP laws are in effect.
This supports the fact that a strong IP regime encourages development of local R&D, and if demonstrated in USA, there was little reason to believe why this would not follow suit in Pakistan.
IP rights were rights of any investor who has dedicated time and resources in bringing out a discovery/invention and it should not be perceived as an issue of Local versus Multinationals. We should look forward to the time when the local industry, through development of their R&D, would be submitting patent application for their discoveries.
Regarding patent protection resulting in monopoly by MNCs and thereby result in high price of drugs, it needs to be remember that the pharmaceutical market was highly regulated by the Government and prices of all drugs are fixed by Ministry of Health and no Company could arbitrarily fix the price of its own medicines.
Similarly, with regards to questions that all medicines should be "affordable" and seeking reduction in prices to control healthcare costs, one needs to realise that the term "affordable" was relative and cited costs of common consumer items as an example.
He stated that affordability was determined by different economic elements and what was more important was to see if different therapeutic class options were always available to choose from, to treat diseases.
Government and private healthcare institutions, are dependent on ones' socio-economic status, individuals have access to different levels of health care facilities, and this demonstrated that "healthcare affordability" was linked to income. The last price increase was in December 2001 and that too was only 3 percent.
Since December 2001, prices of medicines have remained fixed whereas prices of commodities in all other sectors have gone up. What needs to be reviewed were the doctors' fee, hospital service charges, costs of diagnostic tests, etc as these are the main factors that are presently contributing to yearly increase in healthcare costs.