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Regulatory News | 23 February 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The China Food and Drug Administration (CFDA) has begun a consultation on good supply practices and traceability after suspending the use of a drug monitoring system run by Alibaba-subsidiary Ali Health. In revising its traceability document, CFDA has removed references specific to the electronic drug monitoring system in favor of more general recommendations about good supply practices.
CFDA’s actions come nearly one month after it was sued by a pharmacy over the involvement of Ali Health in the electronic drug monitoring system. The lawsuit alleged the involvement of Ali Health is a conflict of interest. Over the weekend, CFDA formally responded to scrutiny of the platform with two statements, one of which confirmed it is suspending the Ali Health-run system. Reports that CFDA would transfer responsibility for supporting the program from Ali Health to a nonprofit have circulated since the regulator was served with legal papers, but its action goes a step further.
The action amounts to a complete suspension of the implementation of the system. CFDA’s revisions to its good supply practice document further the impression that it is looking to move away from the platform. In the revised text, CFDA has deleted references to the process of scanning barcodes and uploading data to an electronic drug monitoring system, the workflow that is at the heart of the platform built by Ali Health. The text retains the demand for traceability but shies away from setting out exactly how companies should achieve this goal.
In proposing this less prescriptive approach to traceability, CFDA has raised doubts about the future of the platform Ali Health created and the value of investments companies made to bring systems into line with traceability requirements that came into force at the end of 2015. Ali Health has said it is working with the regulator on the potential handover of the platform and is yet to receive a notice telling it to stop providing technical support and maintenance services. Some companies have made significant investments to comply with the Ali Health-focused traceability model.
Ali Health and its investors are already bracing for the loss of the electronic drug monitoring system business. Shares in Ali Health fell 14% following CFDA’s statements, which the company admits could negatively affect its business. Attention is now turning to the outcome of CFDA’s consultation, the feedback period for which is set to close on March 23.
CFDA Notice (Chinese), Ali Health Statement, Reuters, More (Chinese)
The Drug Regulatory Authority of Pakistan (DRAP) is planning to reject hundreds of requests to raise drug prices when it meets to discuss the proposals next month. Yet, with a handful of multinational drugmakers going through the courts to protect unapproved drug price increases, DRAP’s ability to cap the cost of medicines is in question.
Under the Drug Pricing Policy of 2015, control for setting prices should rest with DRAP, which proposed freezing or cutting the amount companies could charge for most drugs. Faced with opposition to its proposal, DRAP included a “hardship” mechanism through which companies could request increases to the prices of drugs in certain circumstances. The mechanism is designed to enable companies to secure higher prices in cases when the drug is economically unviable at the existing cap. DRAP is set to meet next month to discuss the price of 237 drugs that are going through the hardship process.
In each case, the manufacturer thinks it needs to increase the price if it is to keep supplying the drug. However, while the manufacturers are proposing more than doubling the prices of some medicines, DRAP is planning to reject most of the requests. GlaxoSmithKline, for example, has filed to increase the prices of more than 25 drugs, but in most cases DRAP is planning to retain the existing cap. DRAP is proposing to revise the prices of a couple of drugs upward, but even more are actually set to fall. The proposed price of 400 doses of GSK’s antibiotic Septran is 29% below the going rate today.
Faced with a system they see as economically unsustainable, some leading multinational companies have gone to court to protect unapproved price increases. Abbott Laboratories, GSK, Novartis and Sanofi are reportedly among the companies to pursue this strategy, which has been criticized by DRAP and government officials. “The government will not tolerate this injustice with the masses, and will not allow laws to be trampled upon,” Pakistani Health Minister Saira Afzal said in the National Assembly, The Nation reports.
DRAP is also seeking to control prices of certain products through another mechanism in the Drug Pricing Policy of 2015. Drugs including Lipitor are on the list of products facing price cuts.
DRAP Price List, The Nation, More
The Indian Ministry of Ayush is collaborating with the World Health Organization (WHO) on traditional medicines to begin the formation of a network of international regulators that collaborate on traditional and complementary medicine.
India wants to see such a regulatory network established to facilitate the spread of its native forms of alternative medicine. The collaboration, like the creation of the Ministry of AYUSH, an acronym of Ayurveda, yoga and naturopathy, Unani, Siddha and homoeopathy, is part of a drive by the Indian government to increase exports and challenge China in the global market for traditional medicines.
As a first step, India wants WHO to draft technical documents that set benchmarks for aspects of the mix of approaches covered by AYUSH, such as Ayurveda medicine. India sees the creation of these documents leading to increased acceptability of traditional medicines, which, as a whole, are yet to generate clinical trial data to support their widespread integration into clinical care pathways.
Countries are looking to WHO for help generating such data. In a WHO survey of member states in 2012, 65% respondents said there was a “great need” for technical guidance on evaluating the safety and efficacy of traditional medicines. Support with sharing of regulatory information also featured prominently, with 56% of respondents describing this as a great need.
CFDA has established a process to monitor the quality of drugs imported into China. The approach, which CFDA outlined in a letter to port authorities, calls for officials to strictly enforce requirements set out in the Pharmacopoeia of the People's Republic of China.
To support this work, CFDA is asking its regional outposts to strengthen their supervision of import records and management of port inspections, using the more stringent pharmacopoeia that came into force last year to guide their work. The overarching goal is to ensure the safety and quality of drugs coming into China, something CFDA has upped its focus on in recent months.
Having spent the past few years bolstering oversight of quality at drug producers within China, CFDA signaled its intent to go after overseas manufacturers last month when it issued warnings to India’s Aurobindo Pharma and three other manufacturers. At the time, CFDA told port officials to block the importation of drugs cited in its warnings.
CFDA Statement (Chinese)
Tags: Asia Regulatory Roundup, Ali Health, drug monitoring, drug prices, traditional medicine