Amendments in patent laws should be done carefully - Hafiz Azizur Rehman


5th Pakistan Pharma Summit proceedings –V
Amendments in patent laws should be
done carefully - Hafiz Azizur Rehman
We do not have Bioequivalence Centers, there
should be no price control-Sultan Ghani

ISLAMABAD: One of the sessions during the 5th Pakistan Pharma Summit organized by PPMA here on February 19th was devoted to Patent Laws and Access to Medicines. Dr. Hafiz Azizur Rehman Assistant Professor of Law and Legal Advisor to the president of International Islamic University Islamabad was the first speaker. All new drugs, he said, enjoy patent protection and these laws have to be honoured. For pricing and financing policies application and management of intellectual property is essential to contribute to innovation and promote public health. He also referred to Procurement and Supply Chain management, appropriate prescribing and dispensing, regulatory system that assures the quality, safety and efficacy of medicines and vaccines has to be in place. One also has to be prepared to meet any emergencies. This is possible with good governance, monitoring and using key data. Intellectual property organizations are creating hurdles. He was of the view that we should not regulate generic drugs, lobby for change in patent laws.

Amendments in patent laws, he opined, should be done carefully. The issues which needs to be discussed include whether the grant of drug marketing approval by the Drug Regulatory Authority amounts to patent infringement and whether the DRA should act as a patent police to enforce private rights of individuals We have to be mindful of monopoly of innovators which they do not deserve. Post grant patents are very expensive and they are not feasible for the pharmaceutical industry in Pakistan. He suggested that the pharma industry should work together. Speaking about the training of patent office officials, he said that they are trained with a particular mindset. PPMA, he opined, should play a proactive role. Patent monopoly will hit us badly. They should keep in mind the challenges of Licensing and Channing World of Patent Licensing. They must make investment in Human Resource and Research, he added.

Mr. Haroon Qasim moderating a session with Mr. Sultan Ghani who
was the guest speaker in this panel discussion.

In the next session, Mr. Magnus Lindkvist from Trendspotting and a Futurologist made a presentation was on Reclaiming the Future- Taking Back Tomorrow from Lazy futurists, scaremongers. Silicon Valley and Donald Trump. He pointed out that it takes four failures to have a career. If you are enjoying what you do it is a success. He emphasized the importance of planning ahead. Cost of doing things is going down but cost of waiting was going up. Now you need few people and less money to start a company. The traditional ways of doing business are going to disappear. There are seven ways to the future and fist of them was to look elsewhere. He defined R & D, as Rip-off and Duplicate. One should travel where others are not travelling, look good and smell good and say the right things. The next thing was Experimentation. Here, he coined the word “Wedeas”. Be a loser, success is toxic. One must believe in strange logic, he remarked.

The next thing he discussed was growing automation, use of Robots and the use of Artificial Intelligence. Telemarketer, he said, will be replaced by Robots in fifteen years’ time, however least likely to be replaced will be the Dentists and Priests. He quoted Neil Gaiman who had said, “Life is always going to be stronger than fiction because fiction has to be convincing and life does not”. Have an open relationship with rules. Everything starts with failures. If you want to create something new, you have to be willing to misunderstand for a long time. The last way to Future was surviving Three Sorrows. That is how the future begins. He concluded his presentation by saying that “There is an idiot in every company and if you do not know about him, it is you”.

Mr. Zahid Saeed presenting mementoes to Ms. Zeba Ahmad Shuja and Mr. Nadeem Rehmat during the
Pharma  Summit held at Islamabad during February 2020.

Fireside Chat

Mr. Sultan Ghani, Advisor to the Health Minister was the Guest in this session which was moderated by Mr. Haroon Qasim. The topic which came under discussion was the relationship between the pharma industry and the regulatory bodies. Mr. Sultan Ghani clarified that whatever he was saying here were his personal views and it does not represent the viewpoint of the Government. For better growth, he opined, we need a strong industry, better regulations and we need to build bridges. We have to develop a good relationship. The present relationship was unacceptable. Responding to a question as to what motivated him to come back to Pakistan after spending so many years in Canada, Mr. Sultan Ghani remarked that he saw India entering Canadian market. I thought we must have a similar activity from Pakistan. It was the real Trigger. When I got an opportunity, I came here to do something. I wanted to help DRAP. Since 2012 to 2019 I have been struggling to work. Now I got a chance, hence I decided let me change something.

Answering yet another question from Mr. Haroon Qasim as to what DRAP was doing these days, Mr. Sultan Ghani said since the last few years, there has been a trend to change. DRAP is changing but there are roadblocks and he was facing some issues. We can never be successful in shortest possible time. We have a policy which is out of the World. We need to remove those small hurdles. We have to maintain highest standards of quality following Good Manufacturing Practices. Asking drug manufactures to bring down the prices, there are conflicting expectations. Drugs just comprise 15-20% of the total healthcare cost. There could be some balance. Drug prices, he admitted, were very low in Pakistan. He also referred to the importance of bioavailability and bio equality study of Generics which the industry was not doing. We do not have Bioequivalence Centers. There should be no price control. We should have Formulary drugs, health insurance or some other mechanism whereby people should get all essential drugs free.

Mr. Asim Rauf Chief Executive Officer of DRAP who was the Guest of Honour pointed out that in DRAP they review the drugs and approve the drugs. DRAP was currently busy in devising new rules which are based on risks. We believe that the whole process should be undertaken after consulting all the stake holders. If we do not do that, it will create problems. Non-compliance companies should not produce drugs but only those companies who ensure compliance with rules will be allowed to produce drugs. He also disclosed that if they start implementing GMP today, many companies will close down. We give an opportunity to the companies to make up the deficiencies. We intend to have inspection once in three years. Non-compliance companies will be given time and we will revise the Bar, he added.

Mr. Tariq Ikram said that we must know how to build good relationship with the Government. Don’t assume that all those government officials who are occupying coveted positions are fools, they are not. But they must listen to you what is the problem. They are prepared to listen. Similarly the bureaucrats should think how they can help the industry but at times they don’t listen to you. We need to find out what are the reasons. We need to work to gradually build Trust. You will be told where the shoe pinches. He emphasized that the pharma industry must try to build Trust. I have some concerns with hospital pharmacy. For the pharmaceutical industry it is difficult to take the pharmacists and then train them in drug manufacturing. It is the pharmacists who are working in the Regulatory affairs. Pharmacy Council should play its role. During the discussion it was also pointed out that the industry can do a lot as there was great potential for growth but it comes with investment. Do not worry about setting up new plants, old plants can also be approved. Small processes and systems like water system, compressed air and quality management systems needs to be looked into. The industry should not go for too many drugs but opt for diversification. It must focus on Niche products which are needed. These products may not offer more profit. Mr. Sohail Matin said that Control and De-control both systems should work together. There was a need to ensure greater cooperation between the DRAP and the pharmaceutical industry.

Mr. Asim Rauf and Mr. Abdul Razzak Dawood presenting mementoes to Mr. Tauqeer-ul-Haq from Sante and Syed
Jamshed Ahmed from PharmEvo during the 5th Pakistan Pharma Summit held at Islamabad during February 2020.

Panel Discussion
on Patient Safety

Dr. Zakiuddin Ahmad moderated the panel discussion on Patient Safety. The panelists included Mr. Nadeem Rehmat Chief Operating Officer PharmEvo, Ms. Zeba Ahmad Shuja Director Technical Schazoo Zaka, Mr. Abdul Latif Sheikh President and CEO Pakistan Society of Health System Pharmacists, Mr. Hashim Hassan CEO Authentik, Mr. Arshad Mahmood CEO Welwred Pharmaceuticals and Dr. Rizwan Mahmood Director Quality Operations in CCl Laboratories. Mr. Asif Rauf CEO DRAP chaired this session.

In his introductory remarks Dr. Zakiuddin Ahmed said that Medical Errors which are preventable account for 98,000 deaths every year in United States. Studies have shown that one in ten patients are harmed during their stay in the hospital. Fourteen out of every hundred patients are affected by Hospital Acquired infections. This IOM report also revealed that about 2% patients are subjected to surgical complications for the 234 million surgical operations performed every year. Not only that 20-40% of health spending are wasted due to poor quality of care and safety failures and 20% of the hospital costs was due to patient harm caused by adverse events.

One year after this IOM report, yet another landmark study was published by Dr. Barbara who questioned whether the US Healthcare was really the Best in the World. His findings were that about twelve thousand deaths occur due to un-necessary surgeries, seven thousand deaths in hospitals occur due to medical errors and another twenty thousand deaths occur due to other errors in hospitals. Not only that about eighty thousand deaths take place due to infections which the patient acquire in hospitals and all this account for almost two lac twenty five thousand death caused due to medical treatment in hospitals every year. The total number of Americans dying prematurely from medical efforts was about four hundred thousand every year. Hence, this epidemic of patient harm in hospitals needs to be taken more seriously if it has to be reduced. Studies have also showed that adverse events in hospitals may be ten times more than it was previously measured. It is the third leading cause of death in USA. Fundamentals of healthcare include that it must be Safe, Timely, Effective, Efficient, Equitable and Patient centered. Currently more than seven hundred thousand deaths were taking place worldwide due to antibiotic resistance. It is said that almost 50% of antibiotics given in United States are un-necessary and 45% of drugs are given for conditions for which these drugs do not work.

Photographed during the panel discussion at Pharma Summit from (L to R) are Mr. Hashim Hasan, Mr. A. Latif 
Sheikh, Mr. Nadeem Rehmat, Mr. Arshad Mahmood, Dr. Rizwan Mahmood, Ms. Zeba Ahmad Shuja.

Mr. Hashim Hassan opined that patient safety can be enhanced through digitalizing and taking care of the unregistered healthcare facilities. Lot of digital applications are available globally. Mr. Latif Sheikh referred to medical issues, medication issues and pointed out that there were issues with supply chain management and monitoring. Improper use of drugs in healthcare set up cost seventy to ninety billion US Dollars. He also referred to the improper use of drugs in healthcare set up, the issues related to packing of drugs, injectable being filled in similar looking ampoules with different drugs.

Mr. Nadeem Rehmat said that the industry was also concerned about these issues. There is a major risk to the patients. He also referred to the Thalidomide tragedy, the Punjab Institute of Cardiology tragedy in Lahore which resulted in death of numerous precious lives. These are serious issues. They start with the APIs, during quality management systems in manufacturing, how we label and transport the products.

Mr. Arshad Mahmood said that the issues starts with the APIs. He laid emphasis on following international standards of drug manufacturing. Dr. Rizwan remarked that they were the part of this Triangle which consists of DRAP, Pharmaceutical industry and the Patient. We all should be passionate. Every effort should be made to ensure WHO advocated Good Manufacturing Standards are maintained. With the new Generics, we will have to be more careful than before. At present fifty two countries are members of PICS. We should develop people, invest in human resource to ensure better quality.

Dr. Zeba referred to the adverse effects of drugs and the lack of ADR reporting in the country. She opined that initiation of therapy should start with proper diagnosis. Culture and Sensitivity test should be mandatory before the start of antibiotic. In this respect, Bangladesh, she pointed out is much ahead of us. Studies have shown that the child also becomes multi drug resistant (MDR) if mother is multi drug resistant. Pharmacists are custodians of medicines. They must oversee pharmacotherapy. With appropriate medical therapy, patient safety can be enhanced. Quality drugs alone, she remarked, won’t ensure patient safety. Systems controls should be in place to ensure patient safety. Pharmacists can contribute a lot to ensure Patient Safety. Ethical marketing can also promote patient safety. She was of the view that we must implement Quality Management Systems, Pharmacovigilance, ADR monitoring, educate the doctors, nurses. It is unfortunate that at present we do not have a proper ADR monitoring system.

Summing up the discussion Mr. Asim Rauf said that Patient Safety has become much more importance during the last few years. It is essential that safe and effective drugs are researched. Both Drug Regulators and Pharma Industry should come up with Pharmacovigilance studies. At present over seventy drug manufacturers are registered with DRAP. Let us all talk about Pharmacovigilance and find out where does Pakistan stands today. Doctors, he said, do not report ADR and it needs to be encouraged. Discussing patient safety is considered a crime. Media, he felt should also play a positive role. We need to continue with the awareness campaign about ADRs as it is for the benefit of the patient. This issue is interlinked with Drug Regulators, Pharmaceutical Industry and the Prescriber and we need to carry this campaign forward. Patient Safety is a System issue and we must ensure that the Systems are safe, he concluded.

Dr. Shahzad Khan Managing Director and Chief Executive Officer of CCL Pharmaceuticals talked about increasing exports and patient access through Strategic Alliances. He discussed in detail the regulatory compliance, bargaining powers of the suppliers, Threat of new entity, bargaining power of customers, substitutes and the rivalry among the existing companies. Speaking about proportionate allocation of revenue he pointed out that manufacturing account for 31%, Accessibility cost which includes marketing and distribution 27%, profits about 19%, Taxes 6% and Research 1%. The primary function of the pharma industry is to create value by discovering and producing effective medicines, vaccines and services that improve patient’s wellbeing and can be sold in the market at profit. Regulatory challenges increase drug prices. Then there are issues of accessibility, legal challenges, short product life cycle and increase cost pressure.

Speaking about the challenges which require Strategic Alliance, Dr. Shahzad Khan said that at present there are 712 drug manufacturers. The top hundred companies have a total market share of 97.5% and the remaining 2.49% is shared by the remaining 612 pharmaceutical companies. In these circumstances how a company can operate profitably, he asked? In pharmaceutical export market, there is an increasing cost of distribution, cost of regulatory and legal affairs and the cost of branded generic marketing. A smaller organization, he said, is more successful in alliance. CCL, he said was the second biggest exporter of drugs and we have the firsthand knowledge and experience of the challenges one has to face. Nobody is helping us to reduce the cost but we can reduce the cost through strategic alliances, mergers and takeovers. We must work together in collaborative alliance. PICS is an umbrella organization of fifty two countries. We need to build strategic alliances with other countries. Greater number of alliances with result in greater revenues. We can share the competencies through Strategic Alliances. The size of the company matters. Producing drugs or marketing drugs offer lot of opportunities for Strategic Alliances, he remarked.

Dr. Faisal Khan CEO Averos & Cofounder Peshawar made a presentation on The Century of Biology and how Life Sciences has transformed into Engineering Discipline. Biology, he said, has been digitalized. He then referred to the DNA sequence data and pointed out that living organisms are now text file. DNA sequencing cost has been decreasing. Now it is possible to print DNA synthesis. One can copy, paste and edit it. DNA cost has come down to just ten thousand US Dollars. Synthetic Biology, he said, was a new Genetic Engineering and Biotechnology. He then gave details of a Precision Medicine Laboratory set up at Rehman Medical Institute Peshawar in collaboration with some other institutions. Biology, he said, has transformed, its molecular and it is data driven. Costs are like software’s now and there was a big opportunity to reset our Research and Development agenda. We can manufacture APIs which we import and we can have our own clinical trials. All this, he pointed out was happening in Peshawar in Pakistan. This century belongs to Biology and Pakistan should get ready for that. We will soon start clinical trials and try to produce personalized healthcare medicine and for this we are looking for visionary partners in the pharmaceuticals industry, he remarked.

Mr. Ashraf Ul Kabir from HealthTech IBM was the last speaker in this session who discussed can data heal healthcare. Speaking about the disruptive forces he pointed out that market forces were escalating the cost, quality and experience crisis across health systems everywhere. Humans plus Artificial Intelligence was equal to augmented intelligence. We are now witnessing the diabetes epidemic in the 21t century. Daily monitoring of glucose levels have become important. One can use Artificial Intelligence to manage diabetes. We can now track counterfeit drugs. FDA believes in interoperation monitoring of the drugs from manufacturing to the time of patient taking it. Artificial Intelligence is useful for entire drug supply chain and it was particularly useful for Pakistan. If we use it, it will also ensure patient safety, he remarked.

Mr. Haroon Qasim in his concluding remarks pointed out that we have been fortunate to have two federal ministers besides experts like Mr. Latif Sheikh, Mr. Sultan Ghani who are advising the government or are members of different Task Forces and we hope they will convey our feelings to the authorities so that we can have a conducive favorable environment for the pharmaceutical industry to grow and increase drug exports as well.

Dr. Uzair Nagra Zonal Chairman PPMA North and Chief Executive of Medisearch Pharma presented the vote of thanks.