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- 2025-12-20 04:07:28
- Opinion
- [Reporter's view] Reflecting opinions on cold medicine
- by Lee, Hye-Kyung Aug 31, 2022 05:39am
- The Ministry of Food and Drug Safety has been monitoring the supply and demand of cold medicines since March. The targets for monitoring are NSAIDs and Expectorants such as complex cold medicines, Acetaminophen, Ibuprofen, Dexibuprofen, Loxoprofen, and Erdosteine. When pharmaceutical companies computer-report the production (import), sales, and inventory of products to the Drug Safety Country's Weekly Production and Import Status Report system, they have identified cold drugs in circulation and encouraged them to produce insufficient or unproduced items. However, there was a big difference between the results of monitoring the supply and demand status and the distribution of cold medicines felt at the front-line pharmacy site. The Ministry of Food and Drug Safety said that if there are items that are producing and distributing even a little, they are not "out of stock." It is an opinion that pharmacies cannot have inventory of cold medicines with certain ingredients. In the end, officials from the Ministry of Food and Drug Safety said they wanted to resolve the supply and demand of cold medicines only with monitoring results, and the Ministry of Food and Drug Safety established a quick response system for cold medicines using a small-packed drug supply guide system. The Korean Pharmaceutical Association selects 10 items of cold medicines requested by pharmacies and reports them to the Ministry of Food and Drug Safety every week, and when the Ministry of Food and Drug Safety groups the items requested and provides them to the Pharmaceutical Association, the pharmaceutical company enters the system. Although the cold medicine supply and demand monitoring and rapid response system are operating at the same time, the front-line pharmacies still complain that supply and demand are disrupted even if they check inventory in the system and ask wholesalers to supply supplies. The Ministry of Food and Drug Safety is also asking for cooperation from individual pharmaceutical companies and wholesalers in connection with pharmaceutical and distribution associations and distributed prescriptions for cold medicine ingredients that are smooth in supply and demand, but they have no significant effect. The operation of such a system has not caused the cold medicine to be sold out, which occurred during the re-proliferation of COVID-19 earlier this year. It is necessary to solve practical problems about the fact that the supply of cold medicines for specific ingredient preparation is not smooth, and pharmacists who have to prepare prescribed Rx are burdened with difficulties. Just as the public mask system was introduced during the mask crisis, the government plans to establish a public supply management system to actively prevent cold medicine from being sold out in the future. It is commendable that the Ministry of Food and Drug Safety has been continuously checking the distribution status by monitoring the supply and demand status since March in the wake of the cold medicine sold out earlier this year. However, if they respond only with statistics entered into the system, they will have no choice but to file complaints at the front-line sites. In the future, we look forward to actively preparing countermeasures to prevent the second cold medicine from being sold out by steadily reflecting the opinions of the site.
- Opinion
- [Reporter’s View] Unresolved insulin cold chain issue
- by Aug 24, 2022 05:56am
- With no clear alternative found for insulin distribution in Korea, on how to set the regulations for cold chain transport of insulin remains unresolved and beleaguered. Unlike other biological agents that are mainly prescribed in hospitals, insulin is often dispensed at outside pharmacies. And the lives of patients with Type 1 diabetes, who cannot produce insulin in their own bodies, may be threatened if this insulin is not readily available. However, on the pharmaceutical distribution companies’ part, insulin is a ‘white elephant.’ Although it is not a favored item on the companies' part due to its low distribution fee, it is an essential item when considering the companies' business relationship with patients and customers. For this reason, distributors refer to insulin as "a drug that is being distributed as a service item with little or no distribution margin." In other words, although the companies are currently distributing insulin, there is no reason or benefit for the company to distribute it at a loss. When the transport regulations for vaccines were revised earlier last year, and then extended application to all biological products, the government did not consider the difficulty and complexity the revised regulations would bring to insulin distribution. The fact that insulin would be included as biologics may not have even crossed their minds during the revision process. There Ministry of Food and Drug Safety had newly enacted guidelines thereafter to reflect the voices of the industry after receiving countless complaints from the distribution companies but to no avail. Although the newly enacted guidelines showed some progress, such as allowing insulin to be contained in various transport containers and not taking issue with temperature fluctuations during delivery to pharmacies as long as the company can verify the validity of the cold chain process. However, even these changes were not worth the excessively increased workload and cost required to maintain the thorough cold chain requested by the government. In fact, as of July 17th, when the revised regulation was implemented, instability in insulin supply and demand arose at distribution sites. Also, with orders piling up due to fears of stock shortages, this instability in supply and demand continued to deepen. The reduced number of insulin deliveries and extended terms between deliveries to pharmacies further heightened the anxiety of the patients. And due to railing opposition from diabetes patient groups, the MFDS granted an additional 6-month guidance period specifically for insulin distributions. However, anxiety continues to sweep through the industry with the sentiment that this problem cannot be resolved without further consideration of the fundamentals of the revision itself. Officials from distribution companies jointly voiced that “the guidance period is virtually meaningless.” With no distribution, an increased amount of insulin stock would be useless. Also, with the government holding a close eye over the issue, insulin may be better distributed in the short term during the guidance period, but it is clear that the same problem would return as soon as the eye moves away. In other words, there is no other viable option without the additional review of the revised regulations. However, how the revisions should be re-revised remains a further issue, and concerns deepen due to lack of reasonable grounds required for additional revisions of regulations. It is not easy to make further revisions because the regulations were not made after collecting sufficient data and identifying realistic situations in the first place. The government is continuing discussions with the industry, patient organizations, and relevant organizations, and the proposal for holding a public hearing is only now being discussed. It is odd that a public hearing, which should have been conducted before the revision was finalized, is only being discussed now, 8 months after the enforcement of the regulation. It is understandable how frustrated the patients would feel about the unresolvable insulin distribution issue.
- Opinion
- [Reporter's view] Legalization of Non-face-to-face Care
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- Non-face-to-face treatment has become a social topic beyond the health and medical community. Non-face-to-face treatment, which has been temporarily allowed since February 2020, has been on the rise for three years, and the public and domestic medical systems, which are users, have naturally become accustomed to non-face-to-face treatment. Non-face-to-face treatment, which has become a hot topic, is now beyond temporary permission and the need for legislation is emerging. This is because the current medical law and pharmaceutical law principles are shaking due to excessive expediency and some illegal acts of non-face-to-face treatment platform companies derived from temporary permission. The Ministry of Health and Welfare recently reiterated its willingness to institutionalize non-face-to-face treatment to the National Assembly's Health and Welfare Committee and submitted a position to strongly control illegal attempts by delivery pharmacies or non-face-to-face treatment platform companies. The Ministry of Health and Welfare plans to start legislating within the year based on the non-face-to-face treatment bill pending in the National Assembly, and believes that the current face-to-face treatment alone cannot solve the problem of access to medical services such as islands and wallpaper. One more thing is needed to strengthen the legislation of non-face-to-face care. It is an interest in non-face-to-face treatment of the power of the ruling people. Currently, two cases (Choi Hye-young, Kang Byeongwon) have been proposed in the main opposition Democratic Party of Korea alone, including the legislation of non-face-to-face treatment. Shin Hyun-young, the main opposition Democratic Party, also announced plans to propose additional non-face-to-face treatment bills. In the power of the people, the non-face-to-face treatment bill has not yet been proposed. The Ministry of Health and Welfare and the Democratic Party are waiting for the ruling party's representative to propose a bill to strengthen the legislation of non-face-to-face care, but no lawmaker is reportedly interested in the bill yet. Non-face-to-face treatment should start discussions on legislation to strengthen the management of platform companies and the current medical law and pharmacology law principles at the same time as the need to stipulate the system itself as a law. At a time when the number of users of non-face-to-face treatment and non-face-to-face treatment services is exploding, there may be many side effects that need not be experienced if related regulations are established too late. Starting with the representative presentation of the non-face-to-face treatment bill, the ruling party should make efforts to improve legislative completeness by widely accepting the needs of the Ministry of Health and Welfare, the medical community, the Pharmaceutical Association, and the platform companies. It is a way to improve the stability of the health care industry and to prevent the principles of medical law and pharmacology law from being disturbed. It is expected that the ruling party will make an agile move to prevent platform companies from making mistakes in shaking the domestic health care system by neglecting non-face-to-face treatment with some expedient and illegal methods.
- Opinion
- [Reporter’s View] Industry sullen over revised PE exemption
- by Eo, Yun-Ho Aug 17, 2022 05:52am
- The pharmaceutical industry is sullen despite the government's announcement of a measure to expand drug coverage, as the so-called measures for expanded coverage are closer to reductions from the industry’s point of view. The main issue lies in the improvement of the pharmacoeconomic evaluation (PE) exemption system that was included in the “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government. The goal of the improvement is to expand coverage for the pediatric patients. The government added a clause allowing PE exemption for "drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee." The added clause excluded the “life-threatening disease” condition required for PE exemptions in pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. Many multinational pharmaceutical companies and the Korean Research-based Pharmaceutical Industry Association have been requesting the ‘life-threatening’ condition be removed from the eligibility criteria for PE exemptions. In this sense, this exclusion, although limited to pediatric patients, is a valuable step forward. However, a major premise for PE exemptions had also been revised. The government had added the phrase “a small number of eligible patients ” in the revision. This condition had previously been an “OR clause" included in Article 2c of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. In other words, if the amendment is applied in the current state, all drugs that wish to take the PE exemption track would have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2c of the regulation. Multinational pharmaceutical companies have been criticizing that this has narrowed the pathway for PE exemptions rather than expanding it. In fact, the KRPIA had issued a statement immediately after the government announced the revision, criticizing that the amended measure “overlooks the fact that it can demotivate companies from developing innovative new drugs and impede access to severe rare disease treatments.” Although such industry complaints are common following government policy announcements, considering the fact that the new government promised prompt listing of anticancer and rare disease drugs upon inauguration, and the non-reimbursed blind spots still exist for drugs that apply for special exemptions, the government needs to consider whether this revision is achieving its original purpose.
- Opinion
- [Reporter’s View] MFDS opens up, discloses contact info
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The Ministry of Food and Drug Safety is changing. The ministry's efforts to transform into an ‘Open MFDS’ as emphasized by Minister Yu-Kyoung Oh since her day of appointment on May 27th, is showing results. After holding 7 ‘ultimate debate’ sessions in June this year, the MFDS also held 16 roundtable meetings and discussion sessions with the industry, associations, and academia, as well as 2 separate public debates for the medical and food sector to prepare '100 tasks for regulatory innovation.' Based on the feedback accrued, the MFDS announced the final 100 tasks for regulatory innovation on the 11th. The Korea Chamber of Commerce and Industry and the Korea National Council Consumer Organization attended the announcement, signifying the deep public-private communication that had been made in its process. A bigger change is that the contact information for each department in the organizational chart on the MFDS’s webpage that had been hidden since February 22nd last year was disclosed again. At the time, the MFDS deleted the contact information of the officials in charge, deciding that regular business was difficult due to the flood of inquiries and complaints made by the general public regarding COVID-19 vaccines and treatments. Complaints followed this deletion of contact information, but the MFDS only repeated its response that it has prepared a main representative number system for inquiries to resolve the difficulty of making contacts arising from the absence of officials in charge and to increase focus on the ministry's review work. Therefore, the inconvenience caused by the lack of communication was entirely borne by the complainant. The introduction of the ‘core time system’ to allow officials to focus on their regular work, had further caused hardships in reaching MFDS officials. However, the contact information for each department in the organizational chart on the MFDS’s webpage has been disclosed since the 8th. Although the core time system will still be in place, the MFDS decided to reduce its period from the previous 7 hours (10:00 a.m.-5:00 p.m.) to 4 hours (11:00 a.m.-3:00 p.m.). On the day of her appointment, Minister Oh said, “The MFDS needs to become a science and technology expert, crisis management expert, and public communications expert. Communications between ministries, departments, and various stakeholders, as well as internal inter-field and inter-function communication, must be encouraged for growth. I will create an open MFDS in which employees can actively communicate, and one that encourages public-private communication and cooperation." Minister Oh had constantly emphasized communication during her official appearances. She said she will listen to various opinions in the process of preparing and implementing the 100 tasks for regulatory innovation. In 100 days after her appointment, Oh’s determination for communication is coming to fruition in various ways. The reporter hopes that the MFDS’s efforts for ‘open communication’ continue.
- Opinion
- [Reporter’s View] Seek industry opinion before implemention
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Although the government announced measures to reinforce patient access to high-priced severe disease treatments on the 20th of last month, the pharmaceutical industry’s response to the new measures has been lukewarm at best. Moreover, the industry is ferociously criticizing how the government presented the measure without collecting industry opinion. The main point of implementing the new measure was to reduce the reimbursement period while reinforcing post-marketing management, however, the industry is claiming that the measure will have little effect in reducing the reimbursement period while focusing too much on drug price reduction, ultimately further impeding patient access. The government plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through the concurrent operation of reimbursement evaluation and pricing negotiations, among other measures. On this, the Korean Research-based Pharmaceutical Industry criticized, “Reducing 60 days from a review period that already takes up to 3 to 4 times the actual statutory period (210 days) will be insignificant from the patient’s perspective in feeling any improved access. The industry added, that preparing a pharmacoeconomic evaluation exemption regulation for treatments with a small number of patients and improving the maximum discount rate of the Price-Volume Agreement system from the current 10% will only lower motivation for new drug development or reimbursement. The problem is that the government did not seek the pharmaceutical industry’s opinion before announcing the measure. KRPIA also expressed concern regarding this matter, saying that “It is a shame that the government, which had been emphasizing private-public cooperation, disclosed a major policy that may affect the whole field without conferring it with the biopharmaceutical industry.” Since early last year, the government and pharmaceutical associations have been meeting every month through a private-public consultative body established to improve the drug pricing system. However, the measure for improving access to high-priced drugs that had been announced was found to have never been discussed at the meetings. It is difficult to properly implement or promote a policy that is unilaterally announced without collecting the opinions of its users and suppliers. The ‘Lowering the elementary school entry age to 5 years’ policy that was recently withdrawn due to opposition from the education community, was also aborted due to this non-collection of opinions from the education community. Why the Ministry of Health and Welfare, which lacks a head, made such a hasty decision to announce an important policy without collecting opinions from the industry remains in question. If the government respects the pharmaceutical industry as its future driver of growth, it should not exclude the industry in the process of making such serious policies.
- Opinion
- [Reporter's view] COVID-19 vaccination strategy
- by Aug 09, 2022 05:56am
- The MFDS has begun a preliminary review of the vaccine for COVID-19 in Moderna and Pfizer. The preliminary review is to review the submitted clinical data in advance and to quickly determine whether to grant permission when the company applies for an item permit by adding non-clinical and quality data in the future. The divalent vaccine, which Moderna and Pfizer applied for a preliminary review, is a vaccine that expresses each antigen for the initial coronavirus (Wuhan) and the omicron mutation virus BA. It is a combo vaccine that combines two antigens in half, and the two companies began developing it early this year and announced major clinical results in June. The two vaccines were found to have produced more neutralizing antibodies to omicron mutations than conventional vaccines. The problem is that BA.5, an omicron subvariant, spread rapidly and became dominant in Korea. According to the detection rate of major mutant viruses compiled by the Korea Centers for Disease Control and Prevention, the BA.5 detection rate in the fourth week of July was 66.8%, up 10.5 percentage points from the previous week. It became the dominant species 11 weeks after the first BA.5 stool confirmed in Korea on May 12. Modena and Pfizer's divalent vaccine basically expresses antigens against the circular omicron virus, so it has a higher preventive effect on sub-variations than conventional vaccines. However, it was relatively ineffective as it targeted BA.1. According to the announcement of the two companies, the neutralization value of the bivalent vaccine for BA.4/5 was one-third of the number shown in the BA.1 mutation. That's why the FDA has demanded that Moderna and Pfizer develop a new vaccine containing BA.4/5 which is included. At that time, sub-variations were spreading rapidly in the United States, so the FDA seems to have decided that it was necessary to target these mutations. The two companies are focusing their efforts on developing a new vaccine targeting submutation of omicron. South Korea should also consider what vaccination strategy to establish at a time when the omicron submutation has become the dominant species. The FDA is showing its willingness to inoculate vaccines targeting submutations even while minimizing clinical trials of the new vaccine. If there are more BA5 confirmed patients in Korea, the introduction of a BA4/5 vaccine should be accelerated. At the same time, there are differences between the U.S. and Korea. The United States, the mainland, spends the least time getting permits and vaccines. The U.S. health authorities have already signed a purchase contract for the BA.4/5 vaccine with Moderna and Pfizer. On the other hand, South Korea has relatively late permits, contracts, and domestic introduction schedules. A situation beyond the end of this year may occur. Unlike the United States, which has not been approved for a divalent vaccine, Korea needs to have an alternative solution called a divalent vaccine for omicrons. Health authorities should benefit the public most through reasonable choices within limited time and resources.
- Opinion
- [Reporter’s View] New guideline refrains off-label NOAC use
- by Eo, Yun-Ho Aug 02, 2022 06:02am
- Off-label refers to the use of drugs for an indication other than those approved by the Ministry of Food and Drug Safety. Although people may question the need for off-label use when the appropriate use for a drug has already been set by the health authorities, these off-label prescriptions are made at the doctor’s discretion. Often, off-label use of a drug is encouraged or shunned according the situation of each disease or drug. Voices on their necessity or non-necessity are also raised accordingly. The latter goes for new oral anticoagulants (NOACs). Relevant societies and specialists have continuously raised concerns over the prescription of low-dose NOACs, but still, this low-dose off-label prescription trend persists in Korea. Recently, the Korean Heart Rhythm Society (KHRA) published the revised “Guidelines for NOAC use in atrial fibrillation patients," which presented specific standards for NOAC use according to each situation. After collecting and discussing all data on the use of various doses, the KHRA guideline decided to recommend the use of on-label doses according to each indication. The first NOAC was approved in 2011 and listed for reimbursement in 2013. Currently, 4 NOACs have landed in the field in Korea. Quite a time has passed since NOACs landed in Korea, but still, off-label prescriptions of NOACs have not lessened much. According to the National Institute of Health, over half - 64.4% - of the patients that use NOACs in Korea are being prescribed low-dose NOACs. The leading cause of this off-label use is bleeding concerns. Asians have a smaller physique and different genetic characteristics than Westerners, therefore, worries that the bleeding risk may increase with the use of standard-dose NOACs is why doctors have been prescribing the low-dose NOACs against indications. Of course, off-label use of drugs is allowed at the doctor’s discretion according to his/her medical judgment. However, the indication of a drug is approved based on clinical research on a large number of patients that is conducted to identify the appropriate dose. The ultimate purpose of using NOACs is to prevent strokes. If prescribing low-dose NOACs in fear of bleeding rather increases the number of stroke patients, this in itself would be a huge loss. Off-label use of drugs is like a double-edged sword. It is this reporter's wish that the new guidelines will guide patients who are tired of using warfarin and practitioners that were reluctant to use anticoagulants due to lack of high-priced monitoring equipment and difficult prescription management to fully enjoy the benefits provided by NOACs.
- Opinion
- [Reporter’s View] MFDS minister wills regulatory innovation
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Ministry of Food and Drug Safety’s determination to seek regulatory innovation has surfaced with the inauguration of President Suk-Yeol Yoon’s administration. The MFDS had previously conducted 7 internal debates for each of its fields during the past 2 months to come up with a plan for ‘administrative innovation in food and drug at an international level', in line with the national goal of Yoon Suk-Yeol’s administration. In fact, regulatory innovation is the first assignment given to the MFDS by Yoo-Kyung Oh, the Minister of Food and Drug Safety that was appointed on May 27th. After holding internal debates and public forum for food and drug regulatory innovation on July 21st and 25th, respectively, the MFDS reported the administrative innovation measures for advancing into a global food and drug industry to become a core bio-digital healthcare country to the state affairs review and coordination meeting on July 28th. The MFDS plans to establish and present a ‘100 project roadmap’ to support its innovative measures on the 100th day of Yoon’s inauguration. Minister Oh’s determination for regulatory innovation was evident in the public debate. Oh sat through the public forum for food and drug regulatory innovation that had been conducted for 2 hours. Oh, who said she will humbly listen to the voices of the public rather than conduct a unilateral debate, closed the public forum saying that “We will make one step further from being an institution that answers questions asked by the public. We aim to enable a two-way communication where the MFDS also asks questions to the public for answers.” Also, the key Director Generals of bureaus that represent the drug area at MFDS appeared on the podium. An official from MFDS said, “During my over 20 years of service at MFDS, I have never seen a forum where 4 key Director Generals from major bureaus personally give presentations and answer questions.” This is because a comment made by MFDS Director Generals at such an event is like an oath made to the public. It needs to be kept, no matter what. Minister Oh’s determination had largely influenced the decision of MFDS Director Generals’ personal presentation of the regulatory innovative tasks under review. Oh is that much determined to achieve the national tasks set by the new government. Oh is expected to personally make the presentation on the 100 tasks that will be made in August. Industry expectations are also rising with the MFDS Minister’s personal interest in regulatory innovation. Among the various regulatory innovations planned, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association expressed that it was pleased by the MFDS’s plan to provide global support and reinforce the fast track system. However, the ministry would need to pull through with its plan to the end. As much as the MFDS had endeavored to identify tasks for regulatory innovations, the ministry would need to keep its determination to implement regulatory innovation measures that can lead to changes in the actual field in 5 or 10 years.
- Opinion
- [Reporter’s View] Secrecy no more in pricing negotiations
- by Eo, Yun-Ho Jul 18, 2022 06:06am
- The importance of providing a clear explanation about an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a regulation, which raises more questions than an introduction or abolition of a system. But the National Health Insurance Service and pharmaceutical companies have never provided an explanation on a drug that extended their drug pricing negotiation period after passing the set deadlines. This non-explanation of such events has persisted despite the increasing drug pricing negotiation extensions that are been made between the NHIS and companies to newly list or expand insurance benefits for select drugs. From the patient’s perspective, the drug pricing negotiations have become a stage of endless wait, a stage without promise. This is in part due to the fact that the negotiation expiry date, extension decision, and other matters discussed and set by the NHIS and the companies are all kept undisclosed under a confidentiality agreement. In other words, there is no way for the third party to know when the 60-day negotiation period has started or ended. This is why more and more patients and healthcare professionals are expressing feeling smothered by the increasing number of negotiation extensions. The NHIS needs to seriously contemplate why the Drug Reimbursement and Evaluation Committee and Cancer Disease Deliberation Committee decided to disclose their deliberation results. In the current “high-priced drug era,” there are plenty of very effective but expensive drugs being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set period of “50 days.” However still, the emphasis needs to be laid on the word, deadline. Deadline is a kind of promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new domestic drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise. Of course, both are to blame for the deadline extension. Negotiation extensions prevail due to a lack of a mindset to bring results within the set period as well as the vague underlying sentiment that the drug will not be listed on the first try because it is an expensive and difficult drug to negotiate. Such sentiment and mindset are what lead to the repetition of exceptional cases. Also, the companies’ time-wasting acts due to delays in communication with their HQ and the administrative department’s complacency of delaying the imminent “negotiation breakdown” due to the fear of the flood of complaints filed by patients obscure the purpose of the system itself. The HIRA’s review process, during which a drug is evaluated based on clinical efficacy and cost-effectiveness, and the drug pricing negotiations, which will directly affect fiscal spending on the authorities’ part, would have to be a sensitive issue for both parties involved. However, on how long the ‘confidentiality’ clause will be considered justifiable must be considered. Times have changed. The patients and patient families will not wait idly anymore.
