Tolak tuntutan harta intelek EU yang memanjangkan monopoli ubat / Reject EU’s intellectual property demands that prolong medicine monopolies

[ENGLISH VERSION BELOW] Pertubuhan masyarakat sivil telah memberi amaran kepada kerajaan Malaysia bahawa cadangan intellectual property yang dibentangkan oleh Kesatuan Eropah (EU) akan melemahkan industri generik Malaysia, menjejaskan persaingan dan meningkatkan harga produk farmaseutikal di Malaysia.

Rundingan pusingan keempat dijangka berlangsung pada 9-12 Jun 2026, menurut maklumat yang disediakan oleh EU.[i]

Empat puluh-enam pertubuhan masyarakat sivil dari Malaysia dan seluruh dunia, dalam surat yang ditujukan kepada menteri pelaburan, perdagangan dan industri, menteri kesihatan dan menteri perdagangan dalam negeri dan kos sara hidup, menyeru kerajaan Malaysia untuk menolak semua kewajipan intellectual property yang melampaui piawaian minimum yang ditetapkan dalam Perjanjian Pertubuhan Perdagangan Sedunia (WTO) mengenai Aspek Berkaitan Perdagangan Hak Harta Intelek, yang dikenali sebagai Perjanjian TRintellectual propertyS.

Pertubuhan masyarakat sivil juga menggesa lebih ketelusan dan akauntabiliti serta perundingan yang bermakna mengenai isu dan cadangan yang dibincangkan dalam setiap pusingan rundingan, memandangkan potensi kesan negatif terhadap persaingan pasaran yang sah, industri generik domestik dan akses kepada produk farmaseutikal mampu milik untuk rakyat.

Penandatangan surat itu termasuk Persatuan Pengguna Pulau Pinang (CAP), Gabungan Persatuan Pengguna Malaysia (Fomca), Persatuan Kanser Prostat Malaysia, Bersama Menentang Kanser, Malaysian Treatment Access & Advocacy Group, Rangkaian Dunia Ketiga (TWN), Médecins Sans Frontières, Health Action International (Belanda), Salud por Derecho (Sepanyol), Peoples’ Health Movement  (antarabangsa) dan Buko Pharma-Kampagne (Jerman).

Antara lain, EU menuntut pelanjutan tempoh paten melebihi tempoh standard 20 tahun, hak eksklusif ke atas data klinikal termasuk data dalam domain awam, eksklusiviti pasaran tambahan ke atas produk perubatan, perlindungan rahsia perdagangan yang meluas dan aktiviti penguatkuasaan sempadan yang berlebihan ke atas barangan yang disyaki melanggar intellectual property ke atas import, eksport dan barangan dalam transit.

Jenis-jenis langkah ini diketahui memanjangkan monopoli farmaseutikal, menangguhkan persaingan generik, meningkatkan kos penjagaan kesihatan dan menjejaskan kesihatan awam, pembangunan industri perubatan dan objektif dasar negara yang lain.

Pengalaman dengan rawatan virus Hepatitis C (HCV) jelas menggambarkan mengapa Malaysia tidak sepatutnya bersetuju dengan tuntutan EU.

Pada 2016, rawatan HCV pemula telah dijual di Eropah pada harga kira-kira €50,000 untuk siri selama 12 minggu, persaingan generik disekat secara berkesan sehingga 2024, disebabkan oleh perlindungan data yang meluas dan eksklusiviti pasaran.

Sebaliknya, pada 2017, Malaysia mengeluarkan lesen penggunaan kerajaan dan menggunakan perlindungan kesihatan awam yang tersedia untuk memudahkan akses kepada versi generik rawatan HCV dari Mesir dengan harga kurang daripada US$300 setiap siri rawatan, membolehkan kerajaan melancarkan rawatan HCV percuma melalui hospital awam.

Ini meluaskan akses secara mendadak dan meningkatkan hasil kesihatan awam kerana Kementerian Kesihatan kini boleh menyediakan rawatan HCV percuma.

Dengan mengurangkan kos rawatan HCV secara drastik, Malaysia telah membuka laluan untuk mencapai sasaran WHO untuk menghapuskan HCV menjelang 2030.

Selanjutnya, walaupun dalam EU, harga produk farmaseutikal di negara yang melaksanakan lanjutan tempoh paten adalah jauh lebih tinggi daripada yang tidak.

Sebagai contoh, truvada yang digunakan untuk rawatan dan pencegahan HIV, dilaporkan berharga sekitar €30 di Belanda (yang tidak memberikan lanjutan tempoh paten) dan kira-kira €800 di Switzerland, di mana lanjutan tempoh paten terpakai.

Kajian juga telah menekankan bahawa lapisan tambahan intellectual property, di luar piawaian WTO, tidak semestinya memberi insentif kepada R&D walaupun di Eropah.

Pertubuhan masyarakat sivil juga mengingatkan keperluan untuk kerajaan Malaysia memastikan ketersediaan pengecualian luas terhadap perlindungan rahsia perdagangan untuk memaksa pendedahan demi kepentingan awam, termasuk menyediakan akses tepat pada masanya kepada produk farmaseutikal mampu milik.

Surat tersebut mengimbau bahawa semasa pandemik Covid, beberapa pengeluar utama enggan mendedahkan rahsia perdagangan pembuatan yang kritikal dan pengetahuan untuk mencegah persaingan, walaupun tidak dapat memenuhi permintaan global untuk produk kesihatan penting.

Sebagai contoh, di Belanda, Roche hanya dapat membekalkan 30% daripada pesanan tetapi enggan mengeluarkan resipi rahsianya untuk penyelesaian yang digunakan dalam ujian Covidnya. Hanya selepas Roche diancam dengan siasatan oleh Suruhanjaya Persaingan EU, Roche dengan cepat bersetuju untuk berkongsi resipi dengan kerajaan.

Surat tersebut menekankan bahawa kerajaan Malaysia telah mengenal pasti industri farmaseutikal generik sebagai keutamaan strategik di bawah pelan induk perindustrian baharunya (NIMP) 2030, yang bertujuan untuk memperkukuh industri untuk meningkatkan kemampuan dan kebolehcapaian ubat-ubatan, meningkatkan sara diri negara, menyokong pembangunan ekonomi domestik, dan mengurangkan defisit perdagangan farmaseutikal negara.

Pada masa yang sama, Malaysia telah menerima pakai dasar kesihatan awam yang penting bertujuan untuk memudahkan akses kepada ubat-ubatan mampu milik, termasuk rangka kerja ubat generik kebangsaan, yang berasaskan dasar ubat nasional Malaysia dan menggalakkan penggunaan ubat generik yang terjamin kualitinya.

“Menerima tuntutan EU yang tidak wajar terhadap intellectual property, adalah tidak serasi dengan strategi industri dan kesihatan awam Malaysia serta keselamatan negara. Negara membangun lain seperti India telah berjaya menentang tuntutan ini, Miti dan Kementerian Perdagangan Dalam Negeri yang bertanggungjawab untuk intellectual property harus melakukan kerja rumah mereka dan menentang cadangan EU yang melangkaui Perjanjian WTO-TRIPS dan bertentangan dengan kepentingan negara”, kata pengarah eksekutif Third World Network, Chee Yoke Ling.

“Harga produk farmaseutikal yang tinggi merupakan cabaran berterusan bagi rakyat Malaysia. Pesakit membayar kos yang tinggi manakala kerajaan mesti memperuntukkan sumber yang besar, seterusnya mengekang perbelanjaan kesihatan awam. Jika kerajaan Malaysia bersetuju dengan mana-mana tuntutan EU yang memanjangkan atau mengembangkan monopoli farmaseutikal, ia akan menjejaskan kesejahteraan rakyat, terutamanya dalam menghadapi isu kemampanan perbelanjaan farmaseutikal, serta tekanan fiskal yang dihadapi Kementerian Kesihatan dengan pengumuman pemotongan bajet baru-baru ini”, kata Mageswari Sangaralingam, ketua eksekutif Persatuan Pengguna Pulau Pinang.

“Pesakit kanser tidak harus menderita kerana perjanjian perdagangan. FTA EU-Malaysia tidak harus memasukkan peraturan TRIPS-plus yang memanjangkan monopoli ubat, menangguhkan persaingan generik yang mampu, dan meningkatkan kos rawatan yang menyelamatkan nyawa. Bagi kebanyakan pesakit kanser, akses tepat pada masanya kepada ubat mampu milik bukanlah isu perdagangan – ia adalah soal kelangsungan hidup. Malaysia mesti mengekalkan ruang dasarnya untuk melindungi kesihatan awam dan memastikan akses kepada rawatan tidak tertakluk kepada kepentingan komersial,” kata Dr Nur Aishah Mohd Taib, presiden Bersama Melawan Kanser (Together Against Cancer).

Surat pertubuhan masyarakat sivil yang ditujukan kepada menteri pelaburan, perdagangan dan industri, menteri kesihatan dan menteri perdagangan dalam negeri dan kos sara hidup boleh didapati di pautan: Bahasa Melayu, Bahasa Inggeris

English version

Reject EU intellectual property demands that prolong monopolies and increase medicine prices

Civil society organisations have warned the Malaysian government that intellectual property proposals being tabled by the European Union (EU) will weaken Malaysia’s generic industry, undermine competition and increase prices of pharmaceutical products in Malaysia.

The fourth round of negotiations is expected to take place on 9-12 June 2026, according to information made available by the EU.

Forty-six civil society organisations from Malaysia and around the world, in a letter addressed to the investment, trade and industry minister, the health minister and the domestic trade and cost of living minister, called on the Malaysian government to reject all intellectual property obligations that go beyond the minimum standards set out in the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (commonly known as the TRIPs Agreement).

Civil society organisations also called for greater transparency and accountability,, as well as meaningful consultations on issues and proposals being discussed in each negotiation round, in view of the potential negative impact on legitimate market competition, the domestic generic industry and access to affordable pharmaceutical products for the people.

Signatories to the letter include the Consumers’ Association of Penang (CAP), the Federation of Malaysian Consumers Associations (Fomca), the Prostate Cancer Society Malaysia, Together Against Cancer, Malaysian Treatment Access & Advocacy Group, Third World Network, Médecins Sans Frontières, Health Action International (Netherlands), Salud por Derecho (Spain), the Peoples’ Health Movement (international) and Buko Pharma-Kampagne (Germany).

Among others, the EU is demanding an extension of the patent term beyond the standard 20-year duration, exclusive rights over the clinical data including data in the public domain, additional market exclusivity over medicinal products, expansive trade secret protection, and excessive border enforcement activities over goods suspected of infringing intellectual property over imports, exports and goods in transit.

These types of measures are well known to prolong pharmaceutical monopolies, delay generic competition, increase healthcare costs, and undermine public health, medical industrial development and other national policy objectives.

The experience with Hepatitis C virus (HCV) treatment clearly illustrates why Malaysia should not agree to EU demands. In 2016, the originator HCV treatment was sold in Europe for about €50,000 for a 12-week course, generic competition effectively blocked until 2024, due to its extensive data and market exclusivity protections.

In contrast, in 2017, Malaysia issued a government-use licence and used available public health safeguards to facilitate access to generic versions of HCV treatments from Egypt for less than $300 per treatment course, enabling the government to roll out free HCV treatment through public hospitals. This dramatically expanded access and improved public health outcomes, as the Ministry of Health can now provide free HCV treatment. By drastically reducing the cost of HCV treatment, Malaysia has paved a pathway to achieve WHO’s target of eliminating HCV by 2030.

Further, even within the EU, prices of pharmaceutical products in countries that implement patent term extension is far higher than those that do not.

For example, truvada used for the treatment and prevention of HIV, reportedly costs around €30 in the Netherlands (which did not grant patent term extension) compared to about €800 in Switzerland, where patent term extension is applicable.

Studies have also highlighted that additional layers of intellectual property, beyond WTO standards, do not necessarily incentivise research and development even in Europe.

Civil society organisations also cautioned the need for the Malaysian government to ensure the availability of broad exceptions to trade secret protections to compel disclosure in the public interest, including to provide timely access to affordable pharmaceutical products.

The letter recalls that during the Covid pandemic, several major manufacturers refused to disclose critical manufacturing trade secrets and know-how to prevent competition, despite being unable to meet global demand for essential health products. For example, in Netherlands, Roche was only able to supply 30% of the orders and yet refused to release its secret recipe for a solution used in its Covid tests. Only after Roche was threatened with investigation by the EU Competition Commission did Roche quickly agree to share the recipe with the government.

The letter highlights that the Malaysian government has identified the generic pharmaceutical industry as a strategic priority under its new industrial master plan 2030, which seeks to strengthen the industry in order to improve the affordability and accessibility of medicines, enhance national self-sufficiency, support domestic economic development, and reduce the country’s pharmaceutical trade deficit.

At the same time, Malaysia has adopted important public health policies aimed at facilitating access to affordable medicines, including the national generic medicines framework, which is grounded in the Malaysian national medicines policy and promotes the use of quality-assured generic medicines.

“Accepting EU’s unjustified demands on intellectual property, is incompatible with Malaysia’s industrial and public health strategies, as well as national security. Other developing countries such as India have successfully resisted these demands. Miti and the domestic trade ministry responsible for intellectual property should do their homework and resist the EU’s proposals that go beyond the WTO-TRIPS Agreement and are against national interest,” said Chee Yoke Ling, the executive director of Third World Network.

“High prices of pharmaceutical products are a persistent challenge for Malaysians. Patients pay high out-of-pocket costs while the government must allocate substantial resources, constraining public health spending. If the Malaysian government agrees to any of the EU’s demands that prolong or expand pharmaceutical monopolies, it would be a disservice to the rakyat (people), especially given the many concerns about the sustainability of pharmaceutical expenditure, and fiscal pressures facing the MoH with the recent announcement of budget cuts,” said Mageswari Sangaralingam, the chief executive of the Consumers’ Association of Penang.

“Cancer patients should not be asked to pay the price for trade deals. The EU-Malaysia FTA must not include TRIPS-plus rules that extend medicine monopolies, delay affordable generic competition, and increase the cost of life-saving treatments. For many cancer patients, timely access to affordable medicines is not a trade issue – it is a matter of survival. Malaysia must preserve its policy space to protect public health and ensure that access to treatment is never subordinated to commercial interests,” said Dr Nur Aishah Mohd Taib, the president of Together Against Cancer.

The civil society letter addressed to the investment, trade and industry minister, the health minister and the domestic trade and cost of living minister is available at: English version, Malay version

Support Aliran's work with an online donation. Scan this QR code using your mobile phone e-wallet or banking app: